optimizing overactive bladder treatment

Conditions: Overactive Bladder

Summary: purpose: this is a pilot randomized double-blind placebo controlled trial of anticholinergic or beta-3 agonist medication with or without concomitant probiotic therapy in women initiating medication therapy for overactive bladder (oab). the aims of this study are to: 1. explore how concomitant probiotic therapy influences response to medication for oab in a randomized controlled trial 2. investigate whether 4 weeks of probiotic therapy alters the urinary microbiome 3. assess for predictors of response to therapy participants: women 18 years of age or older presenting to the division of urogynecology and reconstructive pelvic surgery clinic with oab/uui or uui-predominant mixed incontinence who desire nonsurgical therapy will be eligible for participation. procedures (methods): the study will be conducted over a two-year time frame and the primary outcome will be subjective improvement in symptoms as assessed by the patient global impression of improvement (pgi-i) validated questionnaire at 4 weeks after initiating anticholinergic or beta-3 agonist medication and study drug. the study aims to recruit up to 140 participants randomized in a 1:1 ratio to either concomitant probiotic or placebo medication.

overactive bladder (oab) is a highly prevalent condition that negatively impacts the lives of millions of adults in the united states. anticholinergic and beta-3 agonist medications are commonly used to treat oab but compliance is low due to variable efficacy and bothersome side effects. the existence of a urinary microbiome was recently discovered and early investigations have revealed that lower lactobacillus load is correlated with the presence of oab symptoms and a poorer response to anticholinergic therapy. this proposed pilot study is a randomized double-blind placebo-controlled trial (rct) of concomitant probiotic therapy in women initiating medication therapy for oab to explore how probiotics influence response to anticholinergic and beta-3 agonist medications, investigate whether probiotic therapy alters the urinary microbiome, and assess for predictors of response to therapy. primary aim: to explore how concomitant probiotic therapy influences response to medication for oab in a rct secondary aims: 1. to investigate whether 4 weeks of probiotic therapy alters the urinary microbiome. 2. to assess for predictors of response to therapy

Eligibility criteria:
inclusion criteria: * women age ≥ 18 years * english-speaking * oab/uui or urge-predominant mixed incontinence per the medical epidemiologic and social aspects of aging (mesa) questionnaire exclusion criteria: * neurogenic bladder or urinary retention (postvoid residual (pvr) \>150 ml) * probiotic use within the past 4 weeks * inflammatory bowel disease or history of bariatric surgery * pelvic organ prolapse past the hymen * current symptomatic uti or systemic antibiotic exposure within 4 weeks * current treatment for recurrent uti or history of recurrent uti in the last 6 months * immunosuppressive therapy (i.e., prednisone or chemotherapy) * contraindication to anticholinergic or beta-3 agonist medication (including pregnancy) * prior neuromodulation therapy for oab * inability or unwillingness to comply with study protocol

Keywords: overactive bladder probiotic anticholinergic beta-3 agonist