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Outcomes of Pudendal InterStim

Sponsor
William Beaumont Hospitals (Other)
Overall Status
Completed
CT.gov ID
NCT00719589
Collaborator
(none)
84
Enrollment
1
Location
18
Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    84 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Outcomes of Pudendal InterStim
    Study Start Date :
    Jul 1, 2008
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Jan 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Patient who have had implantation of an interstim.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. To determine the outcomes of pudendal interstim in terms of complications [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients having had Interstim with a pudendal lead at Beaumont
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00719589
    Other Study ID Numbers:
    • 2008-152
    First Posted:
    Jul 21, 2008
    Last Update Posted:
    Mar 24, 2010
    Last Verified:
    Mar 1, 2010
    Keywords provided by , ,
    Voiding Dysfunction
    Interstim

    Study Results

    No Results Posted as of Mar 24, 2010