NCT06754189

Safety and Performance of UCon Patch Electrode

Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: InnoCon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g., suppressing undesired bladder/bowel activity to relieve the symptoms of the patient. This pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.

Detailed description

The overall purpose of this pivotal clinical investigation is to evaluate the UCon device with a Patch Electrode with respect to clinical safety and device performance in a cohort of 180 patients with OAB/BD over a period of 12 weeks. The participants participate in a 12-week intervention period. For weeks 1-6, participants will be randomized (2:1 randomization) to either a treatment group using UCon-Patch with Time Limited stimulation or a sham group using UCon-Sham with sham stimulation. Participants in the treatment group will receive the actual stimulation with the intent of improving their symptoms, whereas those in the sham group will receive sham stimulation for short periods of time believed not to be capable of improving their symptoms. For weeks 7-12 of the intervention periods, the treatment group has the opportunity to add Urge stimulation to the Time Limited stimulation, while the sham group shifts to using UCon-Patch Time Limited stimulation. To assess the safety and performance of the UCon device on equal terms with similar devices in the market, the full intervention period with UCon will be conducted over 12 weeks, evaluating safety aspects of UCon on longer terms and confirming continued effects after 6 weeks in the treatment group. Additional analyses on data related to primary and secondary endpoints with safety and performance data from the 12-week follow-up will also be performed, but the primary analysis will focus on baseline and 6-week follow-up data.

Conditions

• Urinary Incontinence
• Urinary Incontinence, Urge
• Nocturia
• Urinary Frequency More Than Once at Night
• Urinary
• Incontinence, Nighttime Urinary
• Fecal Incontinence
• Fecal Incontinence With Fecal Urgency

Interventions

Type	Name	Description
DEVICE	Time Limited stimulation	The participant self-administer 30 min. of electrical stimulation using Time Limited stimulation to the dorsal genital nerve (DGN) for 6 weeks using UCon with the UCon-Patch electrode.
DEVICE	Sham stimulation	The participant self-administer 30 min. of sham stimulation to the dorsal genital nerve (DGN) for 6 weeks using a sham device with the UCon-Patch electrode.

Timeline

• Start date: 2025-03-20
• Primary completion: 2028-03-20
• Completion: 2028-03-20
• First posted: 2024-12-31
• Last updated: 2025-03-27

Locations

3 sites across 1 country: Denmark