Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

Study Overview
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Brief Summary
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The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

Detailed Description
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The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems. This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

Official Title
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Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

Conditions
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Neurogenic Overactive Bladder, Urinary Incontinence, Detrusor Overactivity

Intervention / Treatment
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* Device: InterStim Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incomplete upper motor neuron lesion Detrusor overactivity Two leaks or two notices of leaks per day Mean functional bladder capacity (volume voided per episode) of ≥100 ml Exclusion Criteria: Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves. Degenerative disease of the central nervous system

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ON / OFF<br>Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks. | Device: InterStim Therapy<br>* Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.<br>|
| Other: OFF / ON<br>Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks. | Device: InterStim Therapy<br>* Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Bladder Capacity | Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups. | Baseline, 4 weeks after implant, 8 weeks after implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurogenic overactive bladder, Urinary incontinence due to incomplete spinal cord injury, Neuromodulation, Neuromodulation for treatment of neurogenic overactive bladder, Patients with Urge urinary incontinence and detrusor overactivity