Phase 3
Completed N=87
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Source: ClinicalTrials.gov NCT00080470 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Number of Leaks Per Day — NA; NA Number of Leaks Per Day
Summary
This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Leaks Per Day |
NA; NA | — |
| PRIMARY Freedom From Major Complications |
0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Age 18 years and above.
- Diagnosed with urinary urge incontinence.
- Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.
- Have normal upper urinary tract function.
- Be capable of giving informed consent.
- Be capable and willing to follow all study related procedures.
Key Exclusion Criteria
- Have any active implantable device regardless of whether stimulation status is ON or OFF.
- Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period.
- Less than one year post partum and/or are breast-feeding.
- Have any passive implant that contains metal or electrically conductive materials.
- Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.
- Have conditions requiring diathermy procedures.
- Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
- Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
- Have history of coagulopathy or bleeding disorder.
- Have a history of pelvic pain as primary diagnosis.
- Have anatomical restrictions such that the study device placement is not possible.
- Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
- Have a life expectancy of less than 1 year.
- Cannot independently comprehend and complete the QoL questionnaires.
Data sourced from ClinicalTrials.gov (NCT00080470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.