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Outcomes of Pudendal InterStim

This study has been completed.
Sponsor:
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00719589
First received: July 17, 2008
Last updated: March 23, 2010
Last verified: March 2010
History of Changes
  Purpose

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).


Condition
Voiding Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Outcomes of Pudendal InterStim

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • To determine the outcomes of pudendal interstim in terms of number of failed sacral lead patients that can be salvaged with a pudendal lead, [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the outcomes of pudendal interstim in terms of complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patient who have had implantation of an interstim.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719589

Locations
United States, Michigan
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospital - Royal Oak
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, William Beaumont Hospital-Royal Oak
ClinicalTrials.gov Identifier: NCT00719589     History of Changes
Other Study ID Numbers: 2008-152
Study First Received: July 17, 2008
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Voiding Dysfunction
Interstim

ClinicalTrials.gov processed this record on May 21, 2013