Urinary and prostate
Everything in the library studied for it, medical and holistic together. Within each kind, what was shown to help comes first, strongest evidence first. What was tested and not shown to help stays on the list.
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
Medication
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].
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].
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.
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].
Kidney stone prevention
Mixed results: a pooled analysis of 10 trials found 37% fewer stone recurrences on thiazides, and the largest trial found no difference from placebo.
The numbers and sources
- Effect
- A meta-analysis of 10 randomized trials found fewer stone recurrences on thiazides than placebo (RR 0.63, 95% CI 0.49 to 0.83), with substantial heterogeneity (I² 65%) [12]. In the largest trial, symptomatic or radiologic recurrence occurred in 59% on placebo and in 59%, 56% and 49% on hydrochlorothiazide 12.5, 25 and 50 mg, with no relation between dose and recurrence (P = 0.66) [13].
- Population
- 650 people on thiazides and 672 on placebo in 10 trials [12]; 416 people with recurrent calcium-containing kidney stones followed a median 2.9 years [13].
- Sources
- [12], [13]
- Caveats
- The pooled trials are mostly older and smaller than [13]. Not an FDA-approved use [14].
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].
Supplements
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].
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].
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.
Therapies
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].
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].
Practices
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.
Lab markers
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.
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].
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].