NCT00441935

Brief Summary

The study is to collect information from patient charts and patient questionnaires to evaluate the effects of nerve stimulation therapy on urinary dysfunction.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
736

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2016

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

12.7 years

First QC Date

February 28, 2007

Last Update Submit

December 21, 2017

Conditions

Urinary RetentionUrinary IncontinencePelvic Pain

Keywords

Urinary RetentionUrinary IncontinencePelvic Pain

Study Arms (1)

Interstim Neuromodulation

Subjects undergoing implantation of an Interstim device for neuromodulation.

Device: Interstim Neuromodulation

Interventions

Interstim NeuromodulationDEVICE

Two stage procedure to implant an interstim device for neuromodulation.

Interstim Neuromodulation

Eligibility Criteria

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

patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak

You may qualify if:

  • All patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak, Michigan who give informed consent to participate in the project.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary RetentionUrinary IncontinencePelvic Pain

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Study Officials

  • Kenneth Peters, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

April 1, 2004

Primary Completion

December 16, 2016

Study Completion

December 16, 2016

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

US(1)