Bladder and prostate
What research found here. What was shown to help comes first, then the risks reported, most common first.
Bladder and prostate
Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on
Shown to help16
Urinary symptoms from an enlarged prostate
Shown to lower prostate symptom scores more than placebo in men with an enlarged prostate, by about 1 to 3 points, with small gains in urine flow.
Compared with placebo [1][2][3][4][5][6][7]
The numbers and sources
- Effect
- Against placebo, tamsulosin 0.4 mg lowered the Boyarsky symptom score 1.1 points more (95% CI 0.72 to 1.49, a 12% improvement) and 0.8 mg 1.6 points more, and raised peak urine flow 1.1 mL/sec more [1]. Silodosin lowered urologic symptom scores 2.65 points more than placebo (95% CI 2.08 to 3.23) [2]. A review of newer drugs found silodosin improved symptoms more than placebo, with moderate strength evidence [3]. In the label trials, the AUA symptom score fell 8.3 points on tamsulosin 0.4 mg and 5.5 on placebo over 13 weeks in one study [4], the IPSS fell 6.5 and 6.3 points on silodosin 8 mg against 3.6 and 3.4 on placebo over 12 weeks [5], and it fell 3.6, 6.9 and 6.5 points on alfuzosin 10 mg against 1.6, 4.9 and 4.6 on placebo in three trials [6]. Doxazosin raised maximum flow 2.3 to 3.3 mL/sec against 0.1 to 0.7 on placebo, and 34 to 42% gained 3 mL/sec or more against 13 to 17% [7].
- Population
- 4,122 men in 14 tamsulosin trials of 4 to 26 weeks, mean age 64 [1]; 1,968 men in 4 silodosin placebo trials [2]; over 9,000 men in 23 trials of newer drugs [3]; 1,486 men in two US tamsulosin trials [4]; 923 men in two silodosin trials [5]; about 1,150 men in three alfuzosin trials [6]; 609 men in three doxazosin trials [7].
- Sources
- [1], [2], [3], [4], [5], [6], [7]
- Caveats
- Trials were short, mostly 12 to 13 weeks, and no placebo trial in [1] ran past 13 weeks. The Cochrane review rated the silodosin symptom evidence low quality [2]. Label trials were run by the makers.
Passing a ureteral stone
Shown to raise stone passage, about 116 more per 1,000 in placebo-controlled trials, mainly for stones over 5 mm. Stones of 5 mm or less showed no clear benefit.
Compared with placebo or standard therapy [9]; placebo or control [10]
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- Across all trials, stone clearance rose on an alpha-blocker (RR 1.45, 95% CI 1.36 to 1.55, low quality). In the higher-quality placebo-controlled trials the effect was smaller (RR 1.16, 95% CI 1.07 to 1.25), or 116 more clearances per 1,000. For stones 5 mm or smaller the RR was 1.06 (95% CI 0.98 to 1.15). Expulsion took 3.40 fewer days and hospital stays were fewer (RR 0.51) [9]. A second meta-analysis found more passage overall (RR 1.49, 95% CI 1.39 to 1.61), no clear benefit for smaller stones (RR 1.19, 95% CI 1.00 to 1.48) and 57% more passage for larger ones (RR 1.57, 95% CI 1.17 to 2.27), with less surgery (RR 0.44) [10].
- Population
- 10,509 adults in 67 trials, 5,787 of them in 15 placebo trials, with stones 1 cm or smaller [9]; 55 randomized trials [10].
- Sources
- [9], [10]
- Caveats
- Many trials were small and at risk of bias, and effects shrank in placebo-controlled trials [9]. Most trials used tamsulosin.
Stone fragments after shock wave lithotripsy
Shown to raise clearance of stone fragments after lithotripsy, from 69% to about 80%, in evidence a Cochrane review rated low certainty.
Compared with usual care alone or with placebo [13]
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- Stone fragment clearance rose on an alpha-blocker plus usual care (RR 1.16, 95% CI 1.09 to 1.23), from 69.3% to an estimated 80.4%, or 111 more per 1,000. Auxiliary treatments fell from 9.7% to 6.5% (RR 0.67, 95% CI 0.45 to 1.00), major adverse events fell from 25.8% to 15.5% (RR 0.60), and clearance came 3.74 days sooner [13].
- Population
- 4,793 adults in 40 trials, only 4 of them placebo-controlled, mean stone size 7.1 to 13.2 mm [13].
- Sources
- [13]
- Caveats
- Low certainty evidence with high heterogeneity (I² 78%) [13]. Most trials used tamsulosin.
Urinating again after a catheter for urinary retention
Shown to help men urinate after catheter removal for acute urinary retention, 60% against 38% on placebo.
Compared with placebo [14]; no treatment [14]
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- 366 of 608 men (60.2%) on an alpha-blocker urinated without a new catheter, against 185 of 486 (38.1%) on placebo (RR 1.55, 95% CI 1.36 to 1.76). Repeat acute retention was less frequent (RR 0.69, 95% CI 0.60 to 0.79), significant for alfuzosin, tamsulosin and silodosin but not doxazosin. Adverse effects did not differ significantly (RR 1.19, 95% CI 0.75 to 1.89) [14].
- Population
- Men in 9 randomized trials, 8 against placebo and 1 against no treatment, with the catheter removed after 1 to 32 days of the drug [14].
- Sources
- [14]
- Caveats
- Moderate quality evidence, and trials defined success differently [14]. Later surgery was not reported.
Bladder infection in women
Shown to cure uncomplicated bladder infections in women far more often than placebo, about 5 times the odds, while amoxicillin-clavulanate cured fewer than ciprofloxacin, 58% against 77%.
Compared with placebo [8]; ciprofloxacin [9]
The numbers and sources
- Effect
- Clinical success (OR 4.81, 95% CI 2.51 to 9.21), cure (OR 4.67) and clearing bacteria at the end of treatment (OR 10.67) were more likely on antibiotics than placebo, and reinfection or relapse less likely (OR 0.27). Adverse events were more frequent (OR 1.64), and kidney infection did not differ [8]. A 3-day course of amoxicillin-clavulanate cured 58% against 77% on ciprofloxacin, and 60% against 77% even with susceptible bacteria, with vaginal E. coli remaining in 45% against 10% [9].
- Population
- 1,062 nonpregnant adult women with confirmed cystitis in 4 trials [8]; 370 women aged 18 to 45 [9].
- Sources
- [8], [9]
- Caveats
- The placebo trials did not single out the drugs on this page [8].
Urinary incontinence in women, added to pelvic floor training
Shown to raise the share of women reporting cure or improvement when biofeedback was added to pelvic floor muscle training, though biofeedback groups often had more contact time.
Compared with pelvic floor muscle training alone [13]
The numbers and sources
- Effect
- Women given biofeedback with pelvic floor muscle training were more likely to report their incontinence cured or improved than those given training alone; the review reports a risk ratio of 0.75 (95% CI 0.66 to 0.86) [13].
- Population
- 1,583 women with stress, urgency or mixed urinary incontinence in 24 trials [13].
- Sources
- [13]
- Caveats
- Women in biofeedback arms often had more contact with a health professional, and many trials were at moderate to high risk of bias [13].
Prostate cancer and other cancers
Linked to more prostate cancer at higher levels, 29% more in the top fifth across pooled prospective studies, with mixed directions for other cancer sites.
The numbers and sources
- Effect
- In pooled individual data from prospective studies, men in the highest fifth of IGF-1 had an odds ratio for prostate cancer of 1.29 (95% CI 1.16 to 1.43) against the lowest fifth, and the association did not differ by time to diagnosis or by tumor stage or grade [8]. In UK Biobank, each 5 nmol/L higher IGF-1 had a hazard ratio of 1.03 for cancer overall in both men and women (1.01 to 1.06), 1.10 for breast, 1.09 for prostate, 1.07 for colorectal and 1.22 for thyroid cancer. It was 0.91 for lung, 0.86 for ovarian and 0.32 for liver cancer [9].
- Population
- Up to 10,554 men with prostate cancer and 13,618 controls in 17 prospective and 2 cross-sectional studies [8]. 412,645 adults followed for a median 7.2 years [9].
- Sources
- [8], [9]
- Caveats
- Observational. The inverse association with lung cancer appeared only in people who had ever smoked [9].
Overdiagnosis in trials of screening
Shown in screening trials to find cancers that would not have caused harm, estimated at 20.7% to 50.4% of the cancers screening detected.
The numbers and sources
- Effect
- The evidence review for the US Preventive Services Task Force estimated that overdiagnosis occurred in 20.7% to 50.4% of screen-detected cancers [15]. The National Cancer Institute defines overdiagnosis as detecting tumors that would not have caused problems during a person's lifetime [2]. In the European trial at 9 years, 1,410 men had to be screened and 48 additional cancers treated to prevent one prostate cancer death, and its authors reported a high risk of overdiagnosis. At 16 years, 18 men had to be diagnosed per death prevented [16][9]. Screening raised the detection of low-grade cancer: Gleason score 6 or lower in 2.2% of invited men against 1.6% of controls in the UK trial, and a rate ratio of 1.17 (95% CI 1.11 to 1.23) for Gleason 2 to 6 disease in the US trial [8][11].
- Population
- 63 studies with 1,904,950 participants in the evidence review [15]. 162,243 men in the core age group of the European trial [16]. 415,357 UK men [8]. 76,683 US men [11].
- Sources
- [15], [2], [16], [9], [8], [11], [5]
- Caveats
- Overdiagnosis cannot be observed in one man and is estimated from groups. The AUA/SUO guideline states that estimates depend on the population, design and method, that estimates based on excess incidence in trials generally overstate the long-term risk, and that the risk rises with age [5].
Death from prostate cancer decades later, by PSA in midlife
Linked to later death from prostate cancer: 90% of deaths by age 85 were in men whose PSA at 60 was above 2 ng/mL.
The numbers and sources
- Effect
- In Swedish men who gave blood at age 60 and were followed to 85, PSA predicted death from prostate cancer with an area under the curve of 0.90 (95% CI 0.84 to 0.96). Men in the top quarter, above 2 ng/mL, accounted for 90% of the deaths (78% to 100%), though only a minority of them died of the disease. Men at the median or lower, 1 ng/mL or below, had a 0.5% risk of metastasis and a 0.2% risk of death from prostate cancer by 85 [17]. In men who gave blood at 45 to 49, the top tenth of PSA (1.6 µg/L or above) accounted for 44% of later prostate cancer deaths (34% to 53%). Below the median of 0.68 µg/L, the 15-year risk of metastasis was 0.09% [18]. The AUA/SUO guideline cites a US cohort in which 82%, 71% and 86% of lethal cases arose in men above the median at ages 40 to 49, 50 to 54 and 55 to 59 (medians 0.68, 0.88 and 0.96 ng/mL) [5].
- Population
- 1,167 men aged 60 who gave blood in 1981 [17]. 21,277 men aged 27 to 52 who gave blood from 1974 to 1984, with a median follow-up of 27 years [18].
- Sources
- [17], [18], [5]
- Caveats
- Observational, from one Swedish city where PSA testing was rare during follow-up, plus a US cohort described in a guideline. The cut points are medians and upper fractions of a distribution, not reference limits.
Stress urinary incontinence
Shown to reduce weekly leaks in women by about 14 percentage points more than placebo on duloxetine, with one in seven stopping for side effects.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- In clinical study reports for duloxetine, weekly incontinence episodes fell 13.56 percentage points more than on placebo (95% CI 5.53 to 21.59). The number needed to treat for feeling much or very much better was 8 (95% CI 6 to 13). The number needed to harm was 7 for stopping because of an adverse event and 7 for what the authors called an activation event. The authors concluded the harms outweighed the benefits [21].
- Population
- Women with stress urinary incontinence in placebo-controlled trials analyzed from clinical study reports [21].
- Sources
- [21]
- Caveats
- Not an approved use in the US. The abstract does not give the number of trials or women [21].
Prostate cancer
Linked to 29% lower prostate cancer with higher total soy food intake in pooled studies of men, 10% lower in cohort studies alone, with no link to advanced disease.
Compared with the lowest soy intake [13]
The numbers and sources
- Effect
- Total soy food intake was linked to lower prostate cancer (RR 0.71, 95% CI 0.58 to 0.85), 0.61 in case-control studies and 0.90 (95% CI 0.82 to 0.99) in cohort studies. Tofu gave 0.73 and miso 1.01. Total isoflavone intake, fermented soy and blood isoflavone levels were not linked, nor was soy food with advanced prostate cancer (RR 0.87, 95% CI 0.74 to 1.06) [13].
- Population
- Men in 30 articles, 16 of them on total soy intake [13].
- Sources
- [13]
- Caveats
- Observational, and case-control studies gave the strongest results [13]. One review.
Kidney stones
Linked to more kidney stones in men in one large Korean cohort, 72% more at 10 mg/dL or above, with no such pattern in women.
The numbers and sources
- Effect
- In 239,331 Korean adults having health checkups, men with higher uric acid developed more kidney stones in a dose-response pattern. Against below 6.0 mg/dL, adjusted hazard ratios were 1.06 (95% CI 1.02 to 1.11) at 6.0 to 6.9 mg/dL, 1.11 (1.05 to 1.16) at 7.0 to 7.9, 1.21 (1.13 to 1.29) at 8.0 to 8.9, 1.31 (1.17 to 1.46) at 9.0 to 9.9 and 1.72 (1.44 to 2.06) at 10.0 or above. No dose-response association was seen in women [13]. An umbrella review found that the one trial outcome with robust evidence for urate-lowering treatment was fewer recurrences of kidney stones [12].
- Population
- 239,331 adults with 18,777 new cases of kidney stones found on ultrasound [13]. 31 meta-analyses of randomized trials within the umbrella review [12].
- Sources
- [13], [12]
- Caveats
- The cohort is observational, had no dietary data and did not use CT to confirm stones [13].
4 more
Stress urinary incontinence, electroacupuncture
One trial of 504 women found electroacupuncture cut urine leakage by 9.9 g against 2.6 g with sham after 6 weeks.
Compared with sham electroacupuncture without skin penetration [19]
The numbers and sources
- Effect
- At week 6, urine leakage on a 1-hour pad test fell 9.9 g with electroacupuncture and 2.6 g with sham (difference 7.4 g, 95% CI 4.8 to 10.0). Incontinence episodes fell by 1.0 more in weeks 1 to 6 and by 2.1 more in weeks 27 to 30. Treatment-related adverse events occurred in 1.6% and 2.0%, all mild [19].
- Population
- 504 women with stress urinary incontinence, mean age 55, at 12 hospitals in China [19].
- Sources
- [19]
- Caveats
- One trial. The authors call for more research on long-term effects [19].
Long-term progression of an enlarged prostate
One trial found doxazosin cut overall BPH progression 39% against placebo over 4.5 years, but not urinary retention or the need for surgery. Doxazosin with finasteride cut it 66%.
Compared with placebo, finasteride, and doxazosin with finasteride [8]
The numbers and sources
- Effect
- Overall clinical progression, defined as a rise of at least 4 points in the AUA symptom score, acute urinary retention, incontinence, kidney insufficiency or recurrent urinary infection, fell 39% on doxazosin, 34% on finasteride and 66% on the combination against placebo. Acute urinary retention and the need for invasive therapy fell on the combination and on finasteride but not on doxazosin. Symptom scores improved in all three groups, most with the combination [8].
- Population
- 3,047 men with BPH followed a mean 4.5 years in a double-blind trial [8].
- Sources
- [8]
- Caveats
- One trial, and only doxazosin among the alpha-blockers. The abstract gives relative reductions without absolute rates.
- Why limited
- This rests on one trial, of 3,047 people. Strength counts independent studies that agree, so one trial is limited at any size.
Prostate cancer prevention
One trial found prostate cancer in 18.4% on 5 mg against 24.4% on placebo over 7 years in men aged 55 or older.
The numbers and sources
- Effect
- Over 7 years on finasteride 5 mg, prostate cancer was found in 18.4% against 24.4% on placebo, a 24.8% relative reduction in prevalence (95% CI 18.6 to 30.6). Urinary symptoms were less common and sexual side effects more common on finasteride [7].
- Population
- 18,882 men aged 55 or older with PSA of 3.0 ng/mL or lower [7].
- Sources
- [7]
- Caveats
- One trial, at 5 times the hair loss dose, in older men. High-grade tumors were more common on finasteride (see Risks) [7]. Funded by the National Cancer Institute [7].
- Why limited
- This rests on one trial, of 18,882 people. Strength counts independent studies that agree, so one trial is limited at any size.
Overactive bladder
One uncontrolled study found lower overactive bladder symptom scores after 12 weeks of pumpkin seed oil in 45 adults.
Compared with before the oil, in the same people [5]
The numbers and sources
- Effect
- In 45 people with overactive bladder, oil from Cucurbita maxima pumpkin seeds at 10 g a day for 12 weeks significantly lowered the Overactive Bladder Symptom Score at 6 and 12 weeks [5].
- Population
- 45 adults with overactive bladder in Japan [5].
- Sources
- [5]
- Caveats
- No placebo or control group, so the fall cannot be separated from time or expectation. The abstract does not give the size of the change. The oil came from a different pumpkin species, Cucurbita maxima, than most other trials on this page [5].
Reported risks22
False positive results and complications of biopsy
Shown to give false positive results to 17.8% of men screened in the European trial, with 0.5% to 1.6% of men biopsied afterward admitted to hospital.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- Of 61,604 men screened in the European trial, 17.8% received a false positive result. In three cohorts, complications needing hospital admission occurred in 0.5% to 1.6% of men who had a biopsy after an abnormal screening result [15]. The National Cancer Institute reports that about 6% to 7% of men have a false positive result on any one screening round, and that about 25% of men biopsied for a raised PSA are found to have prostate cancer [2]. A meta-analysis estimated by modeling that for every 1,000 men screened, about 1 more would be admitted to hospital for sepsis, 3 more would need pads for urinary incontinence and 25 more would report erectile dysfunction [13].
- Population
- 61,604 screened men in the European trial, and three cohorts with 15,136 men who had a biopsy [15].
- Sources
- [15], [2], [13]
- Caveats
- The frequency band is for a false positive result among men screened in the European trial. Hospital admission after biopsy was uncommon to common, at 0.5% to 1.6%. The meta-analysis notes that direct trial data on biopsy and treatment complications were limited, so its figures are modeled [13].
Harms of treating a cancer found by screening
The US Preventive Services Task Force states about 1 in 5 men have long-term urinary incontinence after radical prostatectomy and 2 in 3 long-term erectile dysfunction.
The numbers and sources
- How common
- Very common: more than 1 in 10 people.
- Effect
- The task force lists erectile dysfunction, urinary incontinence and bowel symptoms as harms of prostate cancer treatment. It states that about 1 in 5 men who have a radical prostatectomy develop long-term urinary incontinence and 2 in 3 experience long-term erectile dysfunction [14]. In a trial of men with screen-detected cancer, neither surgery nor radiation was associated with significantly lower prostate cancer mortality than active monitoring, though each lowered the risk of metastatic disease [15].
- Population
- Men treated for prostate cancer in the studies the task force reviewed [14]. 1,643 men with screen-detected prostate cancer [15].
- Sources
- [14], [15]
- Caveats
- These are harms of treatment, which follow a test result only when a cancer is found and treated. The frequency band applies to men who have a radical prostatectomy, not to all men tested.
Genital yeast infections
Shown to raise genital yeast infections about fivefold, to about 4% to 6% of people against about 1% on placebo, and to about 11% of women on canagliflozin.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- Across trials, genital tract infections were more common on SGLT2 inhibitors than comparators (OR 5.06, 95% CI 3.44 to 7.45) [14], and all three drugs raised the odds by a similar amount (ORs 4 to 6 against placebo) [15]. In pooled empagliflozin trials, genital mycotic infections occurred in 4.1% on 10 mg and 3.7% on 25 mg against 0.9% on placebo. In women the rates were 5.4% and 6.4% against 1.5%, and in men 3.1% and 1.6% against 0.4% [20]. In pooled dapagliflozin trials the rates were 5.7% on 5 mg and 4.8% on 10 mg against 0.9% [23]. On canagliflozin, 10.6% and 11.6% of women had an infection against 2.8% on placebo, and 4.2% and 3.8% of men against 0.7% [24].
- Population
- Placebo and active-controlled trials in type 2 diabetes [14][15]; 1,976 adults on empagliflozin and 995 on placebo in five trials [20]; a 12-trial dapagliflozin pool [23]; four placebo-controlled canagliflozin trials [24].
- Sources
- [14], [15], [20], [23], [24]
- Caveats
- People with a past genital yeast infection had them far more often during the trials (23.1% to 25.0% on dapagliflozin against 10.0% on placebo) [23]. Under 1% stopped treatment over these infections [20][24].
Urinary hesitation and erectile problems in adults, atomoxetine
Shown to raise urinary hesitation to 5.6% against 0.5% and urinary retention to 1.7% against none in adults, and erectile dysfunction to 8% of men against 1%.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- In adult trials, urinary hesitation occurred in 5.6% (30 of 540) against 0.5%, and urinary retention in 1.7% (9 of 540) against 0%. Erectile dysfunction occurred in 8% of men against 1%. Rare cases of priapism, an erection lasting over 4 hours, were reported after approval in children and adults [9].
- Population
- 540 adults on atomoxetine and 402 on placebo, and 943 men on atomoxetine against 869 on placebo [9].
- Sources
- [9]
- Caveats
- Priapism reports have no denominator.
Frequent urination
Shown to raise excessive urination in placebo-controlled trials, 6.7% on torsemide against 2.2% on placebo, and 15% at 10 mg for blood pressure.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- In US placebo-controlled trials, excessive urination occurred in 6.7% on torsemide and 2.2% on placebo. In hypertension trials it rose with dose, 1% on placebo, 4% on 5 mg and 15% on 10 mg [1].
- Population
- 564 people on torsemide and 274 on placebo, treated 1 to 52 days [1].
- Sources
- [1]
- Caveats
- Excessive urination was generally not reported as an adverse event in people treated for heart, kidney or liver failure [1].
Urinary tract infections
Mixed results: an early review found more urinary tract infections, while a 2026 trial-level meta-analysis found no significant rise in any or serious infections.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- An early meta-analysis found urinary tract infections more common on SGLT2 inhibitors (OR 1.42, 95% CI 1.06 to 1.90) [14]. A 2026 meta-analysis of outcome trials found a pooled RR of 1.14 for any urinary tract infection (95% CI 0.99 to 1.32) and 0.99 for serious or complicated infection (95% CI 0.78 to 1.27) [25]. In pooled empagliflozin trials, urinary tract infection was reported by 9.3% on 10 mg and 7.6% on 25 mg against 7.6% on placebo. The labels list urosepsis and kidney infection among postmarketing reports [20].
- Population
- Trials in type 2 diabetes [14]; 62,542 participants in 11 trials across type 2 diabetes, heart failure and chronic kidney disease [25]; 2,971 adults in five empagliflozin trials [20].
- Sources
- [14], [25], [20]
- Caveats
- Heterogeneity was substantial in the 2026 analysis (I² 76.0%) [25]. Among people aged 75 and over, rates were higher in every group including placebo [20].
Increased urination
Shown to cause more frequent urination in about 3% on empagliflozin against 1% on placebo in pooled trials.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- In pooled empagliflozin trials, increased urination was reported by 3.4% on 10 mg and 3.2% on 25 mg against 1.0% on placebo, and thirst by 1.7% and 1.5% against 0%. In a 5-day study, daily urine volume rose by 341 mL on day 1 and 135 mL on day 5 [20].
- Population
- 2,971 adults with type 2 diabetes in five trials [20].
- Sources
- [20]
- Caveats
- The figures are for empagliflozin.
Complications of bowel surgery for deep endometriosis
Case series: after removal of a bowel segment for deep endometriosis, rectovaginal fistula averaged 2.3% to 3.6%, anastomotic leak 1.7% and urinary retention about 5%.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- Rectovaginal fistula averaged 3.6% (range 0 to 16.6%) with conventional resection and 2.3% (0 to 10.5%) with nerve-sparing resection. Anastomotic leak averaged 1.7% with both. Urinary retention occurred in 4.5% and 4.9%, and long-term bladder catheterization in 4.9% and 5.6% [17].
- Population
- 7,549 women in 63 studies of segmental bowel resection for colorectal endometriosis [17].
- Sources
- [17]
- Caveats
- Uncontrolled series with inconsistent reporting. This applies to deep bowel disease, not to excision or ablation of superficial lesions [17].
High-grade prostate cancer and PSA
One trial found high-grade prostate tumors in 6.4% on 5 mg against 5.1% on placebo. The label warns of this risk and of lowered PSA.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- High-grade tumors (Gleason 7 to 10) were found in 6.4% of men on finasteride 5 mg against 5.1% on placebo over 7 years [7]. The Propecia label carries a warning on an increased risk of high-grade prostate cancer with 5-alpha reductase inhibitors and on the drug lowering PSA [10].
- Population
- 18,882 men aged 55 or older [7].
- Sources
- [7], [10]
- Caveats
- One trial, at 5 times the hair loss dose, in older men.
- Why limited
- This rests on one trial, of 18,882 people. Strength counts independent studies that agree, so one trial is limited at any size.
Bladder and urinary symptoms
Limited evidence: esketamine raised urinary frequency slightly, 3% against 0.5%. Severe bladder damage is described mainly in long-term recreational ketamine users.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- Urinary frequency occurred in 3% on esketamine vs 0.5% on placebo, and no esketamine-related interstitial cystitis was seen in trials up to a year. The label reports ulcerative or interstitial cystitis with long-term off-label use or misuse of ketamine [4]. A review of psychiatric treatment studies found urinary symptoms in 0% to 24.5% of patients, mostly mild, with no change in urinary measures [13]. In recreational users with ketamine uropathy, frequency affected 77.1%, urgency 69.9% and hydronephrosis 30.2%, and bladder capacity averaged 95 mL [14].
- Population
- Label trials [4]; 27 studies of ketamine for psychiatric disorders [13]; 4,921 patients with ketamine-associated uropathy in 45 studies [14].
- Sources
- [4], [13], [14]
- Caveats
- The uropathy rates are among people who already had the condition, not a rate of harm in users [14]. Most treatment studies did not assess long-term use [13].
Kidney stones
The label reports kidney stones in 1.5% of adults in add-on epilepsy trials, about 2 to 4 times the rate expected in a similar untreated population.
The numbers and sources
- How common
- Common: between 1 in 100 and 1 in 10 people.
- Effect
- Kidney stones occurred in 1.5% of adults in add-on epilepsy trials, more often in men. In an open-label extension in infants aged 1 to 24 months, 7% developed kidney or bladder stones within a year. Topiramate lowers urinary citrate and raises urinary pH [3].
- Population
- Adults in epilepsy trials and 284 infants in an open-label extension [3].
- Sources
- [3]
- Caveats
- Compared with an expected rate, not a placebo group.
Prostate cancer
Linked to slightly more prostate cancer in men, 7% per extra 400 g a day of total dairy and 9% per 50 g of cheese, in pooled cohorts.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Per extra 400 g a day of total dairy, the relative risk of prostate cancer was 1.07 (95% CI 1.02 to 1.12). It was 1.03 (95% CI 1.00 to 1.07) per 200 g of milk, 1.06 per 200 g of low-fat milk and 1.09 (95% CI 1.02 to 1.18) per 50 g of cheese. Dietary and dairy calcium were linked, and nondairy or supplemental calcium were not [16].
- Population
- Men in 32 prospective studies [16].
- Sources
- [16]
- Caveats
- Observational. The review covers total prostate cancer, and few studies reported results by subtype [16].
10 more
Cancer
Mixed results: IARC classes night shift work as probably carcinogenic, mainly from case-control and animal studies, while ten prospective cohorts found no rise in breast cancer.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- IARC found limited evidence in humans, with positive associations between night shift work and cancers of the breast, prostate, colon and rectum in the largest case-control studies but inconsistent results in cohort studies. It found sufficient evidence in animals for altered light-dark schedules, and classed night shift work as probably carcinogenic to humans (Group 2A) [12]. In 10 prospective studies, any night shift work had a breast cancer RR of 0.99 (95% CI 0.95 to 1.03), and 20 or more years an RR of 1.01 (95% CI 0.93 to 1.10) [13].
- Population
- Studies of cancer in exposed people and lifetime studies in mice, reviewed in 2019 [12]. 1.4 million women in 10 prospective studies, 4,660 breast cancers in night shift workers [13].
- Sources
- [12], [13]
- Caveats
- IARC gave case-control studies more weight because they measured shift work in more detail [12]. Group 2A describes the strength of evidence that a hazard exists, not the size of any risk.
Urinary tract injury with laparoscopic hysterectomy
Shown to raise urinary tract injuries in laparoscopic compared with abdominal hysterectomy. Laparoscopic and vaginal routes allowed return to normal activities about 11 to 13 days sooner.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Urinary tract injuries were more likely in laparoscopic than abdominal hysterectomy (OR 2.16, 95% CI 1.19 to 3.93, 18 RCTs, 2,594 women). If ureter injury occurs in 0.2% of abdominal hysterectomies, it would occur in 0.2% to 2% of laparoscopic ones. Return to normal activities was 13.01 days sooner after laparoscopic and 10.91 days sooner after vaginal hysterectomy than after abdominal hysterectomy. Adverse events were rare overall [16].
- Population
- 63 RCTs with 6,811 women having hysterectomy for benign disease [16].
- Sources
- [16]
- Caveats
- Not limited to fibroids. Rare events make the comparisons imprecise [16].
Glaucoma, urinary retention and seizures
The label warns that amitriptyline's atropine-like action can trigger angle-closure glaucoma and urinary retention, and lists caution in people with seizures. It gives no rates.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Pupil widening may trigger an angle-closure attack in people with narrow angles, and even average doses may precipitate an attack in people with angle-closure glaucoma. The label calls for caution in people with a history of seizures or urinary retention [13].
- Population
- Labeling statements [13].
- Sources
- [13]
- Caveats
- No rates are given.
Urinary retention
The levocetirizine label reports urinary retention after marketing, and the diphenhydramine sleep-aid label asks people with prostate enlargement to consult a doctor first. Neither gives a rate.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The levocetirizine label reports urinary retention and names spinal cord lesions and prostate enlargement as predisposing factors [1]. The diphenhydramine sleep-aid label lists difficulty urinating from prostate enlargement, glaucoma and breathing problems such as emphysema as reasons to ask a doctor before use [13].
- Population
- Postmarketing reports and labeling statements [1][13].
- Sources
- [1], [13]
- Caveats
- No rate is given.
Prostate cancer
Linked to slightly higher prostate cancer risk in men with higher total, dietary or dairy calcium intake, in cohort studies. Calcium supplements were not significantly linked.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In 21 prospective cohorts, supplemental calcium was not significantly associated with prostate cancer. Higher total (effect size 1.08, 95% CI 1.01 to 1.15), dietary (1.16, 95% CI 1.08 to 1.24) and dairy calcium (1.13, 95% CI 1.02 to 1.24) intakes were associated with higher risk [19].
- Population
- Men in prospective cohort studies [19].
- Sources
- [19]
- Caveats
- Observational intake data, not trials. Highest against lowest intake comparisons [19].
Gallbladder disease and incontinence
Limited evidence: one trial reported more gallbladder disease and urinary incontinence during estrogen plus progestin, with most risks fading after stopping.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- During estrogen plus progestin treatment, the WHI reported more gallbladder disease and more urinary incontinence. Most risks faded after stopping [5].
- Population
- WHI trial participants aged 50 to 79 [5].
- Sources
- [5]
- Caveats
- The abstract lists these without event counts.
Gut and urinary effects, discoloration and monitor interference
Limited evidence: gut and urinary effects were the most common reasons for stopping a related compound. The label warns it interferes with pulse oximetry readings.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- Gastrointestinal and urinary effects were the most common adverse events at both higher LMTM doses and the most common reasons for stopping [1]. In the bipolar trial, side effects were described as transient and mild [5]. The label warns that methylene blue interferes with pulse oximetry readings [6].
- Population
- Trial participants in [1] and [5]; label [6].
- Sources
- [1], [5], [6]
- Caveats
- The trials were not designed to rank side effects.
Fournier's gangrene
Case reports: FDA identified 55 cases of a necrotizing infection of the genital area in people on SGLT2 inhibitors over six years, with no rate.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- FDA staff identified 55 cases of Fournier gangrene in people taking SGLT2 inhibitors between March 2013 and January 2019, in 39 men and 16 women aged 33 to 87. All had surgical debridement, and three died. For comparison, FDA identified 19 cases with other diabetes drugs between 1984 and January 2019 [30]. The labels warn of necrotizing fasciitis of the perineum and describe it as rare and life-threatening [23].
- Population
- Spontaneous postmarketing reports to FDA [30].
- Sources
- [30], [23]
- Caveats
- The authors state that spontaneous reports cannot establish cause or incidence [30].
Trouble passing urine
The duloxetine label reports cases of urinary retention after approval, some needing a hospital stay or a catheter. It gives no rate.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The label states that duloxetine belongs to a class of drugs known to affect urethral resistance and that cases of urinary retention have been observed in postmarketing experience [18].
- Population
- Postmarketing reports summarized in labeling [18].
- Sources
- [18]
- Caveats
- No denominator.
Prostate cancer
One trial found about 17% more prostate cancer on vitamin E in healthy men aged 50 or older, 1.6 more cases per 1,000 person-years.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- With extended follow-up, 620 men on vitamin E developed prostate cancer against 529 on placebo (HR 1.17, 99% CI 1.004 to 1.36), an absolute increase of 1.6 cases per 1,000 person-years. Vitamin E plus selenium did not significantly differ (HR 1.05) [4].
- Population
- 34,887 relatively healthy men aged 50 or older in the US, Canada and Puerto Rico [4].
- Sources
- [4]
- Caveats
- One trial. The Physicians' Health Study II, at 400 IU every other day, found no difference [5].
- Why limited
- This rests on one trial, of 34,887 people. Strength counts independent studies that agree, so one trial is limited at any size.
Mixed results4
Death from prostate cancer in trials of screening
Mixed results: an invitation to screening cut prostate cancer deaths by 20% in the European trial and 8% in a UK trial, with no significant change in the US trial.
The numbers and sources
- Effect
- In the European trial, the rate ratio for death from prostate cancer at 16 years was 0.80 (95% CI 0.72 to 0.89), an absolute difference of 0.18%. To prevent one death, 570 men had to be invited and 18 diagnosed [9]. In the US trial the rate ratio was 1.04 (0.87 to 1.24) at a median of 15 years and 0.93 (0.81 to 1.08) at about 17 years [10][11]. In the UK trial of a single invitation, it was 0.96 (0.85 to 1.08) at 10 years and 0.92 (0.85 to 0.99) at 15 years, when 0.69% of invited men and 0.78% of control men had died of prostate cancer [12][8]. A meta-analysis of five trials found screening probably has no effect on death from any cause (incidence rate ratio 0.99, 0.98 to 1.01) and may have no effect on prostate cancer death (0.96, 0.85 to 1.08), or a small effect in the trial at lower risk of bias (0.79, 0.69 to 0.91), about one fewer prostate cancer death per 1,000 men screened over 10 years [13]. The US Preventive Services Task Force estimates that screening men aged 55 to 69 may prevent about 1.3 prostate cancer deaths per 1,000 men over about 13 years [14].
- Population
- 162,389 men aged 55 to 69 in eight European countries [9]. 76,683 US men aged 55 to 74 [10][11]. 415,357 UK men aged 50 to 69 at 573 primary care practices [12][8]. Five trials with 721,718 men [13].
- Sources
- [9], [10], [11], [12], [8], [13], [15], [14], [5]
- Caveats
- The trials tested an invitation to screening followed by biopsy and treatment, not a PSA level. They differed in ways that bear on the results. In the US trial an estimated 86% of control men had some PSA testing, its biopsy cut-off was 4 ng/mL against 3 in the European trial, and 34% of men with a raised result were biopsied against over 90% [10][5]. In the UK trial 36% of invited men had the single test [12]. Deaths from any cause did not differ in the US trial, the UK trial or the pooled analysis [10][8][13].
Chronic prostatitis and pelvic pain
Mixed results: alpha-blockers lowered chronic prostatitis symptom scores about 5 points more than placebo, but a Cochrane review rated the evidence very low certainty.
Compared with placebo [15]
The numbers and sources
- Effect
- Total NIH Chronic Prostatitis Symptom Index scores fell 5.01 points more than on placebo in the short term (95% CI 2.61 to 7.41, 18 studies) and 5.60 points more in the long term (95% CI 0.32 to 10.89, 4 studies). The review set its clinically important difference at a six-point drop or 25% of baseline. Sexual function, quality of life, anxiety and depression differed little [15].
- Population
- 2,061 men with chronic prostatitis or chronic pelvic pain syndrome in 24 trials [15].
- Sources
- [15]
- Caveats
- Very low quality evidence, and the review authors were uncertain of the effect [15].
PSA density, a different quantity
Mixed results: proposed PSA density cutoffs run from 0.07 to 0.15 ng/mL per cc, with lower cutoffs finding more cancers and higher ones raising fewer false alarms.
The numbers and sources
- Compared with
- Prostate biopsy
- Effect
- PSA density is serum PSA divided by the volume of the prostate measured on imaging [5][7]. The AUA/SUO guideline states that numerous studies tie a higher density to the risk of clinically significant cancer on biopsy, that lower thresholds such as 0.07 have higher sensitivity and lower specificity than higher thresholds such as 0.15, and it cautions against using a threshold in isolation [5]. The European guideline reports that several studies found a density over 0.1 to 0.15 ng/mL/cc predictive of prostate cancer, and that men below 0.09 were unlikely (4%) to be diagnosed with clinically significant cancer [7]. In men without cancer, PSA rose with prostate volume (r = 0.55) [4].
- Population
- Studies summarized in two guidelines [5][7]. 471 men aged 40 to 79 [4].
- Sources
- [5], [7], [4]
- Caveats
- PSA density is a different quantity from total PSA and needs a measurement of prostate volume, so the ranges on this page do not apply to it.
Percent free PSA, a different quantity
One study found a free PSA cutoff of 25% detected 95% of cancers and avoided 20% of unnecessary biopsies in men with a total PSA of 4.0 to 10.0 ng/mL.
The numbers and sources
- Compared with
- Prostate biopsy
- Effect
- Free PSA is the share of PSA in blood that is not bound to other proteins, reported as a percentage of total PSA [3]. In men aged 50 to 75 with a total PSA of 4.0 to 10.0 ng/mL and a prostate that felt benign, a cutoff of 25% free PSA or less detected 95% of cancers while avoiding 20% of unnecessary biopsies. The risk of cancer ran from 8% to 56% across the range of percent free PSA, higher at lower percentages [24]. The AUA/SUO guideline states that a lower percent free PSA is associated with a greater likelihood of finding prostate cancer on biopsy [5].
- Population
- 773 men, 379 with prostate cancer and 394 with benign prostatic disease, at seven US medical centers [24].
- Sources
- [24], [5], [3]
- Caveats
- Percent free PSA is a different quantity from total PSA, so the ranges on this page do not apply to it. The study covered only men with a total PSA of 4.0 to 10.0 ng/mL [24].
Not shown to help8
Urinary symptoms from an enlarged prostate
Not shown to improve urinary symptoms or quality of life in men with an enlarged prostate, even at three times the standard dose.
The numbers and sources
- Effect
- In 27 trials (4,656 men), limited to low risk of bias studies, saw palmetto made little to no difference in symptom scores at 3 to 6 months (IPSS MD -0.90 on a 0 to 35 scale, 95% CI -1.74 to -0.07, 9 studies, 1,681 men) or at 12 to 17 months (MD 0.07, 95% CI -0.75 to 0.88), and little to no difference in quality of life, all at high certainty [1]. In 225 men given 160 mg twice a day for a year, symptom scores (MD 0.04, 95% CI -0.93 to 1.01) and urine flow did not differ from placebo [2]. In 369 men given up to 3 times the standard dose over 72 weeks, symptom scores fell 2.20 points on saw palmetto and 2.99 on placebo [3].
- Population
- Men mostly over 50 with moderate symptoms [1][2][3].
- Sources
- [1], [2], [3]
- Caveats
- Ten of the 27 Cochrane trials were industry funded [1]. A meta-analysis limited to one hexanic extract, Permixon, and funded by its maker's Spanish arm, Pierre Fabre Ibérica, reported 0.64 fewer voids a night and 2.75 mL/s more peak flow than placebo [4].
Symptom relief, one alpha-blocker against another
Not shown to differ in symptom relief between silodosin and tamsulosin or naftopidil in men with an enlarged prostate. Alfuzosin did slightly better than silodosin in two small trials.
Compared with tamsulosin, naftopidil and alfuzosin [2]; other alpha-blockers and the saw palmetto extract Permixon [1]
The numbers and sources
- Effect
- Against tamsulosin, silodosin made little to no difference in urologic symptom scores (MD -0.04, 95% CI -1.31 to 1.24, 13 studies) or quality of life. Against naftopidil the difference was -0.85 points (95% CI -2.57 to 0.87). Against alfuzosin, symptom scores were 3.83 points higher on silodosin (95% CI 0.12 to 7.54) [2]. Tamsulosin 0.2 to 0.4 mg improved symptoms and flow about as much as other alpha-blockers [1].
- Population
- 2,129 men in 13 silodosin against tamsulosin trials, 763 against naftopidil and 155 against alfuzosin [2]; men in 14 tamsulosin trials [1].
- Sources
- [2], [1]
- Caveats
- Low-quality evidence for these comparisons [2]. Naftopidil is not sold in the US. The alfuzosin comparison rests on two small trials.
Small ureteral stones in large placebo-controlled trials
Not shown to help small ureteral stones pass in two large trials, where tamsulosin and placebo gave the same rates, 81% against 80% and 50% against 47%.
Compared with placebo and nifedipine [11]; placebo [12]
The numbers and sources
- Effect
- In a UK trial, 81% on tamsulosin 400 µg, 80% on nifedipine and 80% on placebo needed no further intervention by 4 weeks (adjusted risk difference for tamsulosin 1.3%, 95% CI -5.7 to 8.3) [11]. In a US emergency department trial with a mean stone size of 3.8 mm, 50% passed the stone by day 28 on tamsulosin 0.4 mg and 47% on placebo (RR 1.05, 95.8% CI 0.87 to 1.27), and no secondary outcome differed [12].
- Population
- 1,136 adults aged 18 to 65 with a single ureteral stone of 10 mm or less at 24 UK hospitals [11]; 497 adults with stones under 9 mm at 6 US emergency departments [12].
- Sources
- [11], [12]
- Caveats
- Most stones in both trials were small, the group where the meta-analyses also found little effect [9][10]. The US trial excluded people lost to follow-up before stone passage [12].
No single cut point against biopsy
Not shown to separate men with and without prostate cancer at any one cut point: a 4.1 ng/mL cutoff found 20.5% of cancers with 93.8% specificity.
The numbers and sources
- Compared with
- Prostate biopsy
- Effect
- In the placebo group of a US prevention trial, cutoffs of 1.1, 2.1, 3.1 and 4.1 ng/mL detected 83.4%, 52.6%, 32.2% and 20.5% of prostate cancers, with specificities of 38.9%, 72.5%, 86.7% and 93.8%. The area under the curve was 0.678 for any cancer and 0.782 for Gleason grade 7 or higher [19]. Among men in the same trial whose PSA never exceeded 4.0 ng/mL and who had a biopsy after seven years, 15.2% had prostate cancer: 6.6% at 0.5 ng/mL or below, 10.1% at 0.6 to 1.0, 17.0% at 1.1 to 2.0, 23.9% at 2.1 to 3.0 and 26.9% at 3.1 to 4.0. Of those cancers, 14.9% had a Gleason score of 7 or higher [20].
- Population
- 8,575 men aged 55 or older, 5,587 of whom had at least one biopsy [19]. 2,950 men aged 62 to 91 [20].
- Sources
- [19], [20]
- Caveats
- Both analyses come from one trial, whose men entered with a PSA of 3.0 ng/mL or lower. The authors describe a continuum of risk at all values of PSA [19].
One test to the next
Shown to vary from test to test: 44% of men with a result above 4 ng/mL had a result at or below it at a later yearly visit.
The numbers and sources
- Compared with
- The same man's later results
- Effect
- In men tested five times over 4 years, 68 of 154 (44%) with a PSA above 4 ng/mL had a normal result at one or more later visits, as did 116 of 291 (40%) with a PSA above 2.5 [21]. The AUA/SUO guideline states that a newly raised PSA returns to a normal level in 25% to 40% of men on retesting, and cites a study in which 283 of 1,686 men (17%) with a PSA of 3 to 10 ng/mL had a result below 3 eight weeks later [5]. The European guideline reports that one-third of men with a PSA below 10 ng/mL differed by more than 1.0 ng/mL at a second measurement [7].
- Population
- 972 men with a median age of 62 in a trial unrelated to the prostate [21].
- Sources
- [21], [5], [7]
- Caveats
- The AUA/SUO guideline lists urinary tract infection and recent instrumentation of the urinary tract among causes of a temporary rise [5].
Cancer prevention
Not shown to lower cancer in trials mostly of men. One large trial found more prostate cancer on vitamin E.
The numbers and sources
- Effect
- Prostate cancer did not fall. In SELECT, it rose on vitamin E (HR 1.17, 99% CI 1.004 to 1.36) [4]. In the Physicians' Health Study II, prostate cancer (HR 0.97, 95% CI 0.85 to 1.09) and total cancer (HR 1.04, 95% CI 0.95 to 1.13) did not differ [5]. In HOPE, cancer incidence (RR 0.94, 95% CI 0.84 to 1.06) and cancer death did not differ [2].
- Population
- 34,887 men in SELECT [4]; 14,641 male physicians [5]; 9,541 people with vascular disease or diabetes [2].
- Sources
- [2], [4], [5]
- Caveats
- Trials were mostly in men and used synthetic or natural alpha-tocopherol at 400 IU.
Assay calibration
Small studies found one assay read about 20% lower with WHO calibration than with the older Hybritech calibration, and four WHO-calibrated assays still differed by up to 23%.
The numbers and sources
- Compared with
- The same samples measured with another calibration or another assay
- Effect
- In 106 samples, total PSA was 20.3% lower with the World Health Organization calibration than with the Hybritech calibration of the same assay. Applied to 5,865 men, that meant 19% to 20% fewer biopsies and 19% to 20% fewer cancers detected at cutoffs of 3.0 or 4.0 [22]. In 50 patients measured with four assays that were all WHO-calibrated, median total PSA ran 3% to 23% higher on three of them than on the fourth, and free PSA differed by 22% to 49% [23].
- Population
- 106 serum samples and a cohort of 5,865 men [22]. 50 patients at four study sites [23].
- Sources
- [22], [23]
- Caveats
- The cancer detection figures come from a simulation, not from men retested with both calibrations [22]. A cut point set with one assay or calibration may not carry over to another.
Urinary symptoms in men
Not linked to the development or course of lower urinary tract symptoms in 1,306 Finnish men followed for 10 years.
The numbers and sources
- Effect
- Sauna frequency showed no clear association with the prevalence, incidence or remission of 9 of 10 urinary symptoms, or with medication or surgery for them. Feelings of incomplete emptying were less common with frequent sauna use [33].
- Population
- 1,306 men aged 50, 60 or 70 in 1994 who answered questionnaires in 1994, 1999 and 2004 [33].
- Sources
- [33]
- Caveats
- Observational. Of 3,163 men invited, 41.3% answered all three rounds.
Checked, no increase found2
Prostate cancer
Prostate cancer was about as common as on placebo in short to mid-term trials of men. After prostate cancer treatment, recurrence was low in observational data.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- In a meta-analysis of 41 RCTs, testosterone did not raise prostate cancer events (OR 0.88, 95% CI 0.52 to 1.51) or clinically significant prostate cancer (OR 1.13, 95% CI 0.39 to 3.26) [11]. In men treated with testosterone after prostatectomy for prostate cancer, the pooled biochemical recurrence rate was 3.5% (95% CI 1.5 to 8.5) [14]. Across observational studies, recurrence ranged from 0% to 7% after prostatectomy and 0% to 6% after radiotherapy, and progression on active surveillance did not differ from untreated men [15]. Among 295 treated men on active surveillance, no prostate cancer deaths or metastases were reported [16].
- Population
- 11,161 men in 41 RCTs [11]; 398 men in 7 retrospective studies, mean follow-up 29.6 months [14]; 19 observational studies [15]; 295 treated men and 6,826 untreated comparators on active surveillance in 7 observational studies, followed 2.3 to 6.1 years [16].
- Sources
- [11], [14], [15], [16]
- Caveats
- The RCT data are short to mid term [11]. Data in men with prostate cancer are retrospective, mostly in low-risk disease, with no randomized trials [14][15][16].
Saccharin and bladder cancer
Not found in people: FDA states more than 30 human studies did not reproduce the bladder cancer seen in rats, and the warning label was dropped.
The numbers and sources
- How common
- How often is not known: the sources give no rate.
- Effect
- The FDA states that saccharin was linked to bladder cancer in laboratory rats in the early 1970s, that more than 30 human studies since then found the rat results irrelevant to humans, and that in 2000 the National Toxicology Program removed saccharin from its list of potential carcinogens and products no longer carry the warning [3].
- Population
- Human studies summarized by the FDA [3].
- Sources
- [3]
- Caveats
- A regulator's summary. The underlying studies are not cited individually here.
Not studied in people1
Prostatitis
Not studied in people. In lab and animal work its plant sterols block prostaglandin production in the prostate, which a review links to the inflammation of chronic prostatitis.
No study in people. This rests on lab studies, animal studies, how it acts in the body, documented traditional use.
The numbers and sources
- Effect
- A 2023 review of the literature from 1971 to 2021 reports that pygeum bark has been taken traditionally as a decoction for enlarged prostate and urinary and kidney diseases. It attributes most of its activity to phytosterols, mainly beta-sitosterol compounds, which inhibit prostaglandin production in the prostate, and links this to suppressing inflammatory symptoms of enlarged prostate and chronic prostatitis. It reports anti-inflammatory and antimicrobial activity in lab and animal studies [3].
- Population
- Lab and animal studies and ethnobotanical records, reviewed [3].
- Sources
- [3]
- Caveats
- A narrative review of lab, animal and traditional-use evidence. No trial of pygeum in men with prostatitis was located.