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OpenTrials
Completed

NCT Number: NCT00719589

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).

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Key information

Conditions

Voiding Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  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,

    Time frame: 2 years

Secondary outcomes

  1. To determine the outcomes of pudendal interstim in terms of complications

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 21, 2008
Registry last updated
Mar 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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