Types of urethral catheters for management of short-term voiding problems in hospitalized adults: a short version Cochrane Review

Abstract

Aims: This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim1 Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). Methods: Enrolled subjects discontinued OABmedications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (?2 leaks/72 hr) and/or urgency-frequency (?8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months betweenSNMandSMT.Results: Overall, 147 subjects were randomized (70 toSNMand 77 to SMT);93%were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in theSNMgroup (61%) than theSMTgroup (42%; P¼0.02). In the as treated analysis,OABtherapeutic success was76%forSNMand49%forSMT(P¼0.002). TheSNMgroup showed significant improvements in quality of life versus the SMT group (all P<0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. Conclusions: This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms.