Outcomes of Pudendal InterStim

Completed

• Conditions: Voiding Dysfunction

• Registration Number: NCT00719589
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

The purpose of this study is to determine how many patients who have failed treatment with a sacral lead can achieve good results with a pudendal, patients satisfaction with the results of each lead, complication rates after pudendal lead placement, and how many patients have required reprogramming of their device with EMG testing( a more costly procedure).

Detailed Description

InterStim is a bladder pacemaker device that has been in use for over 10 years for patients with voiding dysfunction. Although standard of care is to place the lead at the sacral nerve, in some patients a better response is obtained by placing the lead at the pudendal nerve.

Data will be collected from the subjects medical records and a questionnaire will be mailed one time to assess patients perception of improvement and treatment satisfaction after pudendal Interstim.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-23
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• All patients having had Interstim with a pudendal lead at Beaumont

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the outcomes of pudendal interstim in terms of number of failed sacral lead patients that can be salvaged with a pudendal lead,	2 years

Secondary Outcome Measures

Name	Time	Method
To determine the outcomes of pudendal interstim in terms of complications	2 years

Trial Locations

Locations (1)

William Beaumont Hospital-Royal Oak; 🇺🇸 Royal Oak, Michigan, United States