Clinical Evidence
By decision places trials and approvals in date order under the clinical decision they inform. By trial lists each trial with its bottom line and headline result, linked to a full appraisal of its design, results, harms, limitations and guideline context. The area filter applies to both views.
Trials and approvals in date order, grouped by the clinical decision they inform. Retropubic tension-free vaginal tape and colposuspension had 66% versus 57% six-month objective cure in first-surgery stress incontinence; the difference was not statistically significant. TVT shortened recovery but caused more bladder injuries, and the trial was too small to establish equivalence. In women with stress-predominant incontinence and urethral hypermobility, autologous rectus fascial pubovaginal sling improved 24-month overall and stress-specific success over Burch colposuspension (47% versus 38%; 66% versus 49%), with more urinary tract infections and voiding dysfunction. Retropubic TVT and transobturator TVT-O or Monarc had equivalent objective success at 12 months (80.8% versus 77.7%) under TOMUS's ±12-point margin; subjective success (62.2% versus 55.8%) did not meet equivalence. Complication patterns differed by route. Polyacrylamide hydrogel (Bulkamid) injection was compared with retropubic tension-free vaginal tape in women with primary stress incontinence; 1-year satisfaction of at least 80/100 was 59.8% versus 95.0%, missing the 20% noninferiority limit, while most perioperative complications and all six complication-related reoperations followed tape. Adjustable anchored Ajust or Altis single-incision mini-slings were noninferior to standard retropubic or transobturator midurethral slings for patient-reported improvement at 15 months (79.1% versus 75.6%; adjusted risk difference 4.6 percentage points, 95% CI −2.7 to 11.8). In women with stress-predominant incontinence, behavioral pelvic-floor therapy produced fewer bothersome stress symptoms than a fitted continence pessary at three months, but global improvement did not significantly differ. Adding a pessary to behavioral therapy did not meet the prespecified superiority rule. Before surgery for uncomplicated, demonstrable stress-predominant incontinence, office evaluation alone was noninferior to office evaluation plus multichannel urodynamics for 12-month patient-reported treatment success: 200/259 (77.2%) versus 203/264 (76.9%), with an 11-percentage-point prespecified margin. In women with moderate-to-severe stress urinary incontinence, initial midurethral sling surgery gave higher 12-month subjective improvement than initial pelvic floor physiotherapy (90.8% versus 64.4%) in a modified intention-to-treat analysis; 49.0% of the physiotherapy group crossed over to surgery. In women with mixed urinary incontinence, perioperative behavioral and pelvic floor muscle therapy plus midurethral sling improved 12-month UDI symptoms slightly more than sling alone (adjusted difference −13.4 points, P=.04), below the prespecified 35-point threshold for clinical importance. In stress-continent women having open abdominal sacrocolpopexy for prolapse, adding a standardized Burch colposuspension lowered the composite rate of stress incontinence at 3 months (33.6% versus 57.4%) without a significant difference in urge symptoms; enrollment stopped at the first interim analysis. In stress-continent women undergoing vaginal prolapse repair, adding a retropubic Gynecare TVT sling rather than sham incisions reduced composite urinary incontinence or treatment at 3 months and incontinence at 12 months, with more bladder perforations, urinary infections, bleeding, and incomplete emptying. In 197 older women with urge or mixed incontinence, 8 weeks of biofeedback-assisted behavioral training reduced diary incontinence episodes by a mean 80.7%, versus 68.5% with titrated oxybutynin and 39.4% with placebo; behavioral training beat oxybutynin (P = .04), and both beat placebo. In adults with overactive bladder, vibegron 75 mg daily reduced daily micturitions (1.8 versus 1.3 fewer) and, with urge incontinence, its episodes (2.0 versus 1.4 fewer) more than placebo over 12 weeks; tolterodine extended release, the active reference, gave 1.6 and 1.8. In 1,105 men with persistent overactive bladder symptoms despite an α-blocker for BPH, adding vibegron 75 mg reduced daily micturitions and urgency episodes more than placebo at 12 weeks (differences −0.74 and −0.95 per day); urinary retention occurred in under 1% of either arm. Among 100 adults with OAB randomized to weekly PTNS or extended-release tolterodine, mean daily voids fell by 2.4 and 2.5 at 12 weeks (41 and 43 diaries); PTNS did not meet its noninferiority margin (P = 0.44). Patient-rated cure or improvement was 35/44 versus 23/42. In adults with overactive bladder symptoms after failed conservative care, 12 weekly sessions of percutaneous tibial nerve stimulation (Urgent PC) produced moderate or marked global improvement at 13 weeks in 54.5% versus 20.9% with sham stimulation; no serious device-related adverse events were reported. In patients with neurogenic detrusor overactivity from multiple sclerosis or spinal cord injury, intradetrusor onabotulinumtoxinA 200 U and 300 U cut weekly incontinence episodes at week 6 by 21 and 23 versus 9 with placebo; catheterization for retention rose with dose. In women with idiopathic urgency urinary incontinence, one 100 U onabotulinumtoxinA injection and six months of oral solifenacin (with escalation or a switch to trospium XR) reduced daily episodes similarly (3.3 versus 3.4 fewer); toxin gave more complete resolution but more urinary infection and catheterization. In overactive bladder with urgency incontinence inadequately managed by anticholinergics, intradetrusor onabotulinumtoxinA 100 U reduced daily incontinence episodes more than placebo at week 12 (−2.65 versus −0.87) and produced more positive treatment benefit responses (60.8% versus 29.2%); retention within 12 weeks was 5.4%. In adults with refractory overactive bladder, sacral neuromodulation (InterStim) achieved higher 6-month therapeutic success than standard medication (61% versus 42%, intention to treat), with greater quality-of-life gains; device-related adverse events occurred in 18 of 59 implanted participants (30.5%). In women with refractory urgency urinary incontinence, one 200 U onabotulinumtoxinA injection reduced daily episodes slightly more over six months than staged InterStim sacral neuromodulation (3.9 versus 3.3 fewer; mean difference 0.63), with more urinary tract infections and intermittent catheterization. In 129 adults with urgency urinary incontinence, single-stage implantation of the rechargeable Axonics sacral neuromodulation system without a test phase gave 90% responders at 6 months (episodes 5.6 to 1.3 per day) and no serious device-related adverse events; there was no comparator. In 151 women with urgency urinary incontinence in a single-arm pivotal study, the Revi implantable tibial neuromodulation system, powered by an external ankle wearable, produced a 76.4% intention-to-treat responder rate (at least 50% fewer episodes) at 6 months, above the 50% performance goal. In women having vaginal apical prolapse repair with a midurethral sling, bilateral uterosacral ligament suspension and unilateral sacrospinous ligament fixation had similar 2-year composite surgical success (64.5% versus 63.1%) and serious adverse events; perioperative behavioral therapy with pelvic floor muscle training did not improve outcomes. In women with stage 2 or higher uterine prolapse, vaginal sacrospinous hysteropexy was noninferior to vaginal hysterectomy with uterosacral ligament suspension for apical failure with bothersome bulge or repeat surgery at 12 months (0/102 versus 4/100; difference -3.9 points, 95% CI -8.6 to 0.7). In women with symptomatic uterovaginal prolapse, sacrospinous hysteropexy with Uphold LITE vaginal mesh did not significantly lower 36-month composite treatment failure versus vaginal hysterectomy with uterosacral ligament suspension (24% versus 36%; adjusted hazard ratio 0.61, 95% CI 0.37–1.02; P = .06); mesh exposure was 8%. In two parallel UK trials, uterine preservation did not differ from vaginal hysterectomy (563 women analyzed) and abdominal did not differ from vaginal vault suspension (208) in 12-month Pelvic Organ Prolapse Symptom Score or serious adverse events; abdominal repair cost £570 more. In a first uterus-preserving operation for uterine descent not beyond the hymen, sacrospinous hysteropexy failed the 9% noninferiority margin against the Manchester procedure: 2-year composite success was 77.0% versus 87.3% (difference −10.3%, 95% CI −17.8 to −2.8). Among 360 operated women with symptomatic vault prolapse after hysterectomy, sacrocolpopexy had lower modeled 36-month composite failure than transvaginal native-tissue repair (28% versus 43%); Uphold LITE transvaginal mesh (29%) was noninferior to sacrocolpopexy but not superior to native-tissue repair after multiplicity adjustment. Trocar-guided Gynecare Prolift anterior polypropylene mesh repair increased one-year composite anatomic and symptom success versus traditional anterior colporrhaphy (60.8% versus 34.5%); surgery was longer, bleeding and bladder perforation were more frequent, and mesh exposure required reoperation in 3.2%. Adding a polypropylene mesh inlay or a biological graft to primary transvaginal anterior or posterior prolapse repair did not improve 1-year Pelvic Organ Prolapse Symptom Scores versus native-tissue repair alone; 51 of 434 women who received synthetic mesh had a mesh complication within 2 years. In a randomized crossover comparison with planned three-month periods, ring-with-support and Gellhorn pessaries each improved pelvic floor symptom distress and life impact at follow-up, including early assessments when use stopped; the report found no clinically significant between-device difference in the measured scales. In 447 women with symptomatic stage I to III prolapse, five one-to-one sessions of individualized pelvic floor muscle training over 16 weeks reduced prolapse symptoms more than a lifestyle advice leaflet alone at 12 months (adjusted POP-SS difference 1.52 points on a 28-point scale). Perioperative vaginal conjugated estrogen cream did not improve 12-month composite surgical success versus placebo after native-tissue vaginal apical repair; model-estimated failure was 19% versus 9% (adjusted HR 1.97, 95% CI 0.92–4.22). In 340 UK women using a pessary for prolapse, taught self-management and clinic-based care gave the same 18-month PFIQ-7 score (adjusted difference −0.03 points, 95% CI −9.32 to 9.25); self-management had lower mean cost and women reported fewer pessary complications. In men undergoing surgery for stress incontinence after prostate surgery, a fixed transobturator synthetic sling met the 15-percentage-point noninferiority margin versus an artificial urinary sphincter for strict patient-reported continence at 12 months; symptom scores favored the sphincter. In 115 men receiving the AMS 800 artificial urinary sphincter at 17 centers, 94% (91/97 with pad weights) had at least a 50% reduction in 24-hour pad weight at 12 months, exceeding the 65% performance goal; 60% used no pads and 7.8% had a revision. In 3,047 men with LUTS from BPH followed a mean of 4.5 years, doxazosin plus finasteride cut overall clinical progression risk by 66% versus placebo, more than doxazosin (39%) or finasteride (34%) alone; only finasteride and the combination significantly reduced acute retention and invasive therapy. Over 4 years, dutasteride plus tamsulosin lowered acute urinary retention or BPH surgery versus tamsulosin (4.2% versus 11.9%) but not significantly versus dutasteride alone (5.2%) in men with prostates of 30 mL or more, and improved symptoms more than either drug. Adding invasive urodynamics to routine noninvasive tests in men with bothersome LUTS considering prostate surgery gave an 18-month IPSS noninferior to routine tests alone (adjusted difference −0.33, 95% CI −1.47 to 0.80; margin 1 point) and did not reduce surgery (38% versus 36%). The prostatic urethral lift (UroLift) reduced the AUA symptom index more than sham at 3 months (11.1 versus 5.9 points) in men 50 or older with BPH-related LUTS and 30 to 80 cc prostates without a median lobe; no de novo sustained sexual dysfunction occurred. In 281 men with benign prostatic obstruction and prostates up to 100 g, 180-W GreenLight XPS laser vaporization was noninferior to TURP for 6-month IPSS, Qmax and complication-free proportion, with shorter catheterization and hospital stay. In 197 men with BPH symptoms and 30–80 cc prostates, convective water vapor thermal therapy (Rezūm) reduced IPSS by 11.2 points versus 4.3 with sham rigid cystoscopy at 3 months (p < 0.0001); controls then crossed over, and no de novo erectile dysfunction was reported. Aquablation, an image-guided robotic waterjet resection, was compared with TURP in men with 30 to 80 mL prostates: it was noninferior for 6-month IPSS reduction and had fewer persistent grade 1 or grade 2 or higher complications at 3 months (26% versus 42%). Prostatic artery embolisation was compared with monopolar TURP in 103 randomized men with refractory BPH symptoms: 12-week IPSS fell 9.23 versus 10.77 points, but noninferiority within the 3-point margin was not shown (95% CI −1.45 to 4.52), and TURP improved flow and obstruction more. In 410 UK men with benign prostatic obstruction randomized under anesthesia, thulium laser vaporesection (ThuVARP) and TURP were equivalent for IPSS at 12 months, but TURP gave a higher Qmax; hospital stay and complication rates were similar. In men with BPH-related lower urinary tract symptoms, Optilume BPH paclitaxel-coated balloon dilation improved IPSS by 11.5 points at 12 months versus 8.0 points with a sham procedure at 3 months, but missed its primary endpoint, which added a 25% margin to the sham effect. In 210 men randomized to optical internal urethrotomy (104) or filiform dilation (106) as outpatient treatment for urethral stricture, recurrence-free survival did not differ significantly; recurrence risk rose with stricture length (hazard ratio 1.22 per centimeter, 95% CI 1.05 to 1.43). In 222 randomized UK men with recurrent bulbar urethral stricture, open urethroplasty and endoscopic urethrotomy did not differ in 24-month voiding symptom score (mean difference -0.36), but urethroplasty had fewer reinterventions (15 versus 29 men; hazard ratio 0.52, 95% CI 0.31 to 0.89). In men with recurrent anterior urethral strictures of 3 cm or less after at least two endoscopic treatments, Optilume paclitaxel-coated balloon dilation improved 6-month anatomical success over standard dilation or urethrotomy (74.6% versus 26.8%) and 1-year freedom from repeat intervention (83.2% versus 21.7%). In men with bulbar urethral strictures of 2 cm or less, buccal mucosa graft urethroplasty was followed by fewer patient-reported penile complications than transecting excision and primary anastomosis at 12 months (16% versus 33%); IIEF-5 scores and recurrence (12.9% overall) did not differ. Oral sildenafil versus placebo in 861 men with erectile dysfunction: in a 24-week fixed-dose study, IIEF penetration and erection-maintenance scores rose with 25, 50 and 100 mg; in a 12-week flexible-dose study, 69% versus 22% of intercourse attempts succeeded (P<0.001). In two placebo-controlled trials of stable Peyronie's disease with 30° to 90° curvature, intralesional collagenase clostridium histolyticum with plaque modeling reduced curvature and bother more than placebo with modeling at 52 weeks (pooled curvature 34% versus 18.2%); three corporal ruptures needed surgical repair. In 423 men after bilateral nerve-sparing radical prostatectomy, tadalafil 5 mg daily or 20 mg on demand for 9 months did not improve unassisted erectile function after a 6-week washout versus placebo (20.9%, 16.9%, 19.1%); daily tadalafil improved drug-assisted function and reduced penile length loss. In 110 men with Peyronie's disease, RestoreX penile traction for 30 to 90 minutes daily had only transient, mild adverse events over 3 months and, versus no therapy, increased penile length (1.5 versus 0 cm) and improved composite curvature (−11.7 versus +1.3 degrees). In a retrospective analysis of voluntarily filed manufacturer forms for 39,005 first inflatable penile prostheses, minocycline- and rifampin-impregnated implants had initial revision for infection in 1.1% of 35,737 men versus 2.5% of 3,268 with nonimpregnated implants at up to 7.7 years. In women with a simple fistula closed 7 days after repair, removing the bladder catheter at 7 days was noninferior to 14 days: breakdown from 8 days after catheter removal to 3 months occurred in 10/250 (4.0%) versus 8/251 (3.2%), within a 10-point margin. In 300 women with fecal incontinence, loperamide did not beat oral placebo and anorectal manometry-assisted biofeedback did not beat an education pamphlet for 24-week St Mark's score change; the combination was not significantly better than either component, and constipation was more frequent with loperamide. In women with recurrent urinary tract infection, methenamine hippurate was noninferior to daily low-dose nitrofurantoin, trimethoprim or cefalexin over 12 months (1.38 versus 0.89 antibiotic-treated episodes per person-year; difference 0.49, margin 1), in an open-label trial. In a double-blind trial of 598 women with recurrent UTI in UK primary care, daily D-mannose 2 g for 6 months did not reduce medically attended, clinically suspected UTI versus placebo (51.0% versus 55.7%; risk difference −5 points, 95% CI −13 to 3). In patients with an ileal orthotopic neobladder after radical cystectomy (3-year renal data in 260 of 484 randomized), the antireflux T-pouch did not preserve renal function better than the Studer pouch (eGFR change −6.6 versus −6.4 mL/min/1.73 m²; p=0.35) and needed more diversion-related secondary surgery. In eight hospitals, introducing the WHO 19-item Surgical Safety Checklist was followed by lower in-hospital death (1.5% to 0.8%) and major complications (11.0% to 7.0%) within 30 days than care before implementation, in a prospective before-and-after study of 7,688 patients having noncardiac surgery. Skin cleansing with a 2% chlorhexidine–70% isopropyl alcohol scrub lowered 30-day surgical-site infection versus aqueous 10% povidone–iodine scrub and paint after clean-contaminated surgery in 849 adults (9.5% versus 16.1%; relative risk 0.59, 95% CI 0.41–0.85). Continuous small-bites fascial closure (5 mm bites, 2-0 polydioxanone) was compared with large-bites closure (1 cm bites, looped size 1 polydioxanone) in elective midline laparotomy: incisional hernia at 1 year was 13% versus 21% (adjusted OR 0.52), with similar complications and 4 minutes longer closure. ChEETAh randomized 81 hospitals in seven low- and middle-income countries to routine glove and instrument change before abdominal wound closure versus current practice; 30-day surgical site infection was 16.1% versus 18.9% (adjusted risk ratio 0.87, 95% CI 0.79–0.95).Female stress incontinence
Which operation should treat primary stress incontinence in women?
What testing and nonsurgical care belong before or around SUI surgery?
Should continence surgery be added to prolapse repair?
Overactive bladder
Which behavioral and drug treatments improve overactive bladder symptoms?
Which third-line therapy for refractory OAB or neurogenic detrusor overactivity?
Pelvic organ prolapse
Which apical suspension, and should the uterus be preserved?
Does mesh or graft augmentation improve vaginal repair?
Which nonsurgical treatments help, and do perioperative adjuncts improve surgery?
Male incontinence
Sling or artificial urinary sphincter after prostate treatment?
BPH and male LUTS
Do alpha-blockers, 5-alpha-reductase inhibitors or both prevent progression?
Does urodynamic testing before surgery improve outcomes?
Which procedure relieves BPH symptoms?
Urethral stricture
Endoscopic treatment, drug-coated balloon or urethroplasty?
Sexual medicine
Which treatments work for erectile dysfunction and Peyronie's disease?
Do coated devices reduce penile prosthesis infection?
Fistula
How long should the bladder be drained after fistula repair?
Bowel
Do loperamide or biofeedback improve fecal incontinence?
Urinary infection
Which agents prevent recurrent urinary tract infection?
Urinary diversion
Does an antireflux limb protect the kidneys after orthotopic diversion?
Perioperative care
Which perioperative practices reduce wound complications and surgical harm?