A multi- center, randomized, cross-over study to demonstrate the efficacy of pudendal neuromodulation for the treatment of neurogenic overactive bladder

Phase 4

Completed

• Conditions: neurogenic overactive bladder; urinary incontinence; 10041543; 10004994

• Registration Number: NL-OMON34854
• Lead Sponsor: Medtronic International Trading Sarl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• Eighteen years of age or older;
• Incomplete upper motor neuron lesion due to trauma or disease of the spinal cord (1 year post-lesion);
• Urodynamically proven overactive detrusor function;
• Minimum of 2 leaks or 2 notices of leaks per day (demonstrated on a 5-day voiding diary);
• Mean functional bladder capacity (volume voided per episode) of > 100mL;
• Normal upper urinary tract function as assessed by ultrasound imaging;
• Failed, intolerance or incomplete response to conservative pharmacotherapy;
• Failed or insufficient improvement of symptoms with conservative non pharmacotherapy treatment.

Exclusion Criteria

• Complete spinal lesion or complete bilateral lesion of sacral/pudendal nerves;
• Primary stress incontinence or mixed incontinence where stress component overrides the urge component;
• Degenerative disease of the central nervous system;
• Urinary tract mechanical obstruction such as benign prostatic hyperthropy, cancer or urethral stricture.
• Symptomatic urinary tract infection
• Morphological abnormalities of the bladder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The mean difference in functional bladder capacity, as measured by the average<br /><br>voiding volume per episode, between stimulation ON for 4 weeks and OFF for 4<br /><br>weeks.</p><br>