What clinical trials exist for devices or gene therapies targeting urinary incontinence?
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Executive summary
Multiple device trials — from implantable tibial neuromodulation (eCoin, Altaviva) to digital pelvic‑floor therapeutics and traditional slings/sphincters — are active and have published trial data or FDA actions; implantable tibial systems reported ≥50% reductions in episodes in pivotal trials and eCoin studies showed ~75%+ marked improvement [1] [2]. Gene therapies are in early clinical testing: URO‑902 completed a randomized phase 2a with statistically and clinically relevant reductions in micturitions and urge‑incontinence episodes at 12 weeks, and HSV‑vector EG110A and other vectors have entered dose‑escalation trials for neurogenic bladder [3] [4] [5] [6].
1. Device renaissance: neuromodulation moving from clinic visits to implants
Implantable tibial‑nerve neuromodulation has become a major focus: Medtronic’s Altaviva device gained FDA clearance supported by the TITAN‑2 pivotal trial showing “over 50% reduction in incontinence episodes” as the primary outcome in 188 patients, and smaller capsule‑plus‑bracelet systems (described as paper‑clip‑size implants controlled by an ankle bracelet) are being adopted and studied for patient convenience [1] [7]. Earlier clinical work on eCoin — an implanted tibial stimulator — reported that “upward of 75% of patients saw marked improvement” and high satisfaction in prior studies, and eCoin remains an example of trials that translated into clinical availability [2].
2. Digital and wearable approaches: randomized evidence for non‑implant options
Digital therapeutics and motion‑sensor pelvic‑floor devices have randomized trial data: a virtually executed 8‑week RCT of a motion‑based intravaginal digital device (Leva) randomized 363 women and showed superior symptom improvement at 6 and 12 months versus home training, establishing an evidence base for non‑invasive device therapies [8] [9]. Wearable sensor detection and other non‑invasive monitoring devices are under active study to detect leakage and support behavioral therapies [10].
3. Traditional devices and mechanical supports remain in trials and practice
Surgical slings, artificial urinary sphincters and urethral devices continue to be studied; industry and centers report long‑term “cured or improved” rates for slings and artificial sphincters that inform device‑trial designs and patient counseling [11] [12]. Cochrane‑style reviews note limited high‑quality comparative evidence for many mechanical devices, meaning ongoing trials are essential to define which devices outperform conservative care [13].
4. Gene therapy: promising early‑phase data but small samples and short follow‑up
Plasmid‑based URO‑902 (pVAX/hSlo) completed randomized phase 2a testing via intradetrusor injection, demonstrating clinically meaningful reductions in daily micturitions and urgency/UUI episodes at 12 weeks and a manageable safety profile — multiple reports summarize positive phase 2a findings and journal publication [3] [14] [4]. Separately, HSV‑vector EG110A started a dose‑escalation trial in neurogenic detrusor overactivity after spinal cord injury, with early reports of large reductions in episodes in small cohorts (phase Ib/IIa), and the trial design includes 52‑week follow‑up and a 5‑year safety period [5] [6]. Academic reviews position BK‑channel gene transfer as mechanistically rational but emphasize the need for further study [15].
5. What the trials actually measure — endpoints, duration, and regulatory milestones
Device pivotal trials often use percent reduction in incontinence episodes or patient‑reported outcomes as primary endpoints (TITAN‑2 used >50% reduction) and may have multi‑month follow‑up; gene‑therapy early trials typically report changes at 12 weeks with extended safety follow‑up planned — for example, EG110A’s dose‑escalation study tracks urodynamics at weeks 12 and 52 plus long‑term safety [1] [5] [3]. FDA guidance stresses randomized controlled designs for device approvals because subjective outcomes and placebo effects are prominent in UI research [16].
6. Limitations, open questions and competing interpretations
Promising signals from gene therapy and new implants come from small or early‑phase cohorts; URO‑902 and EG110A data are encouraging but limited in size and duration, and long‑term durability and rare adverse events remain to be proven in larger trials [3] [6]. Device literature includes both robust pivotal data (Altaviva/TITAN‑2) and systematic reviews that call for more comparative trials for many mechanical interventions [1] [13]. Industry reports and press releases (pipeline reports) highlight potential candidates like ICES13 or cell‑based injectables, but those sources require corroboration in peer‑reviewed trial registries or journals [17] [18].
7. Where to look next — registries and trial listings for patients and clinicians
Centers and consortia list active trials across University of California sites, Mayo, and academic centers; registries and summaries from NIDDK and CenterWatch provide curated lists of open studies and device/gene‑therapy programs for recruitment [19] [20] [21] [8]. For clinicians and patients seeking specific protocols, the published phase‑2 URO‑902 report in Journal of Urology and trial identifiers referenced in press coverage are the primary starting points [3] [4].
Sources consulted: University of California trial listings and summaries (device trials, eCoin, TRIUMPH) [19] [22] [20], randomized device trials and reviews (digital devices, mechanical devices, FDA guidance) [8] [13] [16], device approvals and pivotal trial results (Altaviva/TITAN‑2, eCoin) [1] [2], peer‑reviewed and press reports on gene therapies URO‑902 and EG110A and reviews of BK‑channel strategies [3] [14] [4] [5] [6] [15].
Limitations: available sources do not mention head‑to‑head large randomized trials comparing gene therapy versus neuromodulation or slings; long‑term (multi‑year) randomized data on URO‑902 and EG110A are not reported in the provided material (not found in current reporting).