Intravesical Lactobacillus rhamnosusGG versus saline bladder wash: A randomized, controlled, comparative effectiveness clinical trial

Our study objective is to compare the effect of intravesical Lactobacillus rhamnosusGG (LGGÒ) mixed with normal saline, to that of a normal saline bladder wash (BW) in the self-management of urine and bladder symptoms. We have utilized an efficient, two-phase design with separate tests of efficacy: in the first 6-month phase, we test the efficacy of LGGÒ+BW in response to the trigger symptoms of “more cloudy and/or more foul-smelling urine” (treatment phase), while in the second 6-month phase we test its efficacy as a prophylactic intervention (prophylactic phase). In the treatment phase, participants will instill 1 or 2 doses over 24 hours when the trigger symptoms occur. In the prophylaxis phase, participants will initiate prophylaxis with one instillation every 3 days at the first occurrence of trigger symptoms. In both phases, the effects of BW alone are also studied, representing the first ever opportunities for estimation of its effect as an intervention and as prophylaxis. Primary outcomes include urine and bladder symptom burden and secondary outcomes include number of instillations; missed days of work, school, rehabilitation or other activity due to urinary symptoms; engagement with the health care system; number of presumed urinary tract infections; and number of days taking antibiotics.