Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT06091566
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2023-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
Sponsor:
InnoCon Medical
Organization:
Study Overview
Official Title:
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient.
This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.
This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.
Detailed Description:
The overall purpose of the current clinical investigation is to evaluate the medical device with a UCon-Bar Electrode with respect to its initial safety and device performance in a cohort of 40 female patients with OAB/BD over a period of 12 weeks.
The investigation consists of two periods: a screening period and an intervention period.
During the screening period, the participants will be using UCon with a Patch Electrode and complete a 4 week stimulation period at home. The screening period will determine if participants fulfil the criteria to participate in the intervention period.
During the intervention period, the UCon Bar Electrode will be inserted in the clitoral hood. After a recovery period (4-8 weeks), the participants will be using UCon with the Bar Electrode and complete wither a 4 week or a 12 week stimulation period at home.
The investigation consists of two periods: a screening period and an intervention period.
During the screening period, the participants will be using UCon with a Patch Electrode and complete a 4 week stimulation period at home. The screening period will determine if participants fulfil the criteria to participate in the intervention period.
During the intervention period, the UCon Bar Electrode will be inserted in the clitoral hood. After a recovery period (4-8 weeks), the participants will be using UCon with the Bar Electrode and complete wither a 4 week or a 12 week stimulation period at home.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: