Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Inclusion Criteria:

• Women ≥ 21 years

• Bothersome SUI (PFDI-20 Q:#17 of somewhat, moderately or quite a bit) or stresspredominant MUI (PFDI-20 Q:#16 < Q:#17)50 for > 3 months with well-controlled UUI onstable medication treatment through baseline and follow-up.

• A positive cough stress test or urodynamic SUI within the past 18 months.

• Normal voiding function as demonstrated by PVR < 150 mL

• Candidate for either study procedure as determined by treating surgeon (i.e., failedor unable to perform conservative management for SUI including pelvic floorstrengthening and failed or declines pessary option for SUI)

• Available for up to 3 years.

• Agrees to randomization.

Exclusion Criteria:

• Anterior/apical vaginal prolapse beyond the hymen (>0 on POPQ) - Advanced prolapsemay require additional surgery or potentially increase the risk of postoperativeurinary obstruction and confound the results of the study.

• Urge-predominant mixed UI by UDI-6 despite stable therapy - Urge predominant UIwould not be expected to improve after TBA or SIS and may bias results ofinterventions designed specifically for stress urinary incontinence.

• Planned hysterectomy, urethral or anterior/apical surgeries - additional surgerybeyond TBA or SIS has potential to confound the results. Additionally, theseprocedures generally require general anesthesia and indwelling catheterizationimmediately post operatively. The impact of urethral instrumentation after TBA isunknown and could impact the efficacy of the urethral coaptation.

• Malignancy or history of radiation of the pelvis - The risk of foreign materialrejection and mesh complications may be higher in women with pelvic radiation andother treatment for pelvic malignancy may impact primary outcomes.

• Pregnant, breast feeding or plans for pregnancy within 1 year - subsequent vaginaldelivery and hormonal changes of breast feeding prior to primary outcome couldimpact the efficacy of either treatment.

• Incomplete emptying (PVR > 150mL) - SUI surgery may increase the risk of urinaryretention.

• Prior anti-incontinence procedure - the aim of the study is to identify the role ofTBA and SIS in primary, uncomplicated SUI or stress predominant MUI management.

• Neurogenic bladder - the aim of the study is to identify the role of TBA and SIS inprimary, uncomplicated SUI or stress predominant MUI management.

• Prior adverse reaction to synthetic mesh or polyacrylamide - to minimize risk ofpost procedure complications.

• Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painfulbladder syndrome, fibromyalgia, chronic pelvic pain, etc.) - given the known risksof postoperative pain with SIS and higher risks of pain in those with baselinechronic pain, we aim to minimize post operative complications.

• Active 3rd line treatment for OAB/UUI with botulinum toxin, sacral neuromodulationstimulation (SNS) or percutaneous tibial nerve stimulation (PTNS) within 12 monthsor plan for 3rd line or new OAB/UUI treatment within 1 year of SUI surgery. Forthose on stable medication OAB/UUI treatment, participants should be on stabletreatment for 3 months with adequate symptom control prior to baseline measures andplan to remain on stable therapy without 3rd line treatment plans within 1 year ofSUI surgery. Those who have received 3rd line treatment (Botox. PTNS or SNS) shouldhave a washout of 1yr from and no plans for restarting within the primary outcometimeframe of 1 year post procedure. Those using SNS for bowel leakage only and noUUI symptoms do not require minimum 3 months. Participants with MUI on OAB/UUImedication therapy will still need to have SUI worse than UUI at baseline.Randomization will be stratified based on presence of UUI treatment component.

• Active treatment for SUI with a pessary. For those using a pessary or other SUIsupport device, a 3-week washout period should occur prior to assessing baselinemeasures.