Outcomes of Pudendal InterStim

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).

Study Overview

• Status: Completed
• Conditions: Voiding Dysfunction

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 Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital-Royal Oak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients at William Beaumont Hospital-Royal Oak who have had implantation of an Interstim with a pudendal lead.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Patient who have had implantation of an interstim.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
To determine the outcomes of pudendal interstim in terms of complications	2 years

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Kenneth M Peters, MD, William Beaumont Hospital - Royal Oak

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: July 17, 2008
• First Submitted That Met QC Criteria: July 17, 2008
• First Posted (Estimate): July 21, 2008

Study Record Updates

• Last Update Posted (Estimate): March 24, 2010
• Last Update Submitted That Met QC Criteria: March 23, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Voiding Dysfunction; Interstim
• Other Study ID Numbers: 2008-152