Outcomes of Pudendal InterStim

Voiding Dysfunction Clinical Trial

Official title:

Outcomes of Pudendal InterStim

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719589
• Other study ID #: 2008-152
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: March 23, 2010
• Start date: July 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Voiding Dysfunction

Locations

Country	Name	City	State
United States	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the outcomes of pudendal interstim in terms of complications		2 years	No