NCT00719589

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

1.5 years

First QC Date

July 17, 2008

Last Update Submit

March 23, 2010

Conditions

Voiding Dysfunction

Keywords

Voiding DysfunctionInterstim

Outcome Measures

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,

    2 years

Secondary Outcomes (1)

  • To determine the outcomes of pudendal interstim in terms of complications

    2 years

Study Arms (1)

1

Patient who have had implantation of an interstim.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Study Officials

  • Kenneth M Peters, MD

    William Beaumont Hospital - Royal Oak

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 24, 2010

Record last verified: 2010-03

Locations

US(1)