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Outcomes of Pudendal InterStim

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719589
First Posted: July 21, 2008
Last Update Posted: March 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
William Beaumont Hospitals
  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

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 ]

Secondary Outcome Measures:
  • To determine the outcomes of pudendal interstim in terms of complications [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kenneth Peters, MD, William Beaumont Hospital-Royal Oak
ClinicalTrials.gov Identifier: NCT00719589     History of Changes
Other Study ID Numbers: 2008-152
First Submitted: July 17, 2008
First Posted: July 21, 2008
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by William Beaumont Hospitals:
Voiding Dysfunction
Interstim