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InterStim Prospective Database

NCT ID: NCT00441935

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

736 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2016-12-16

Brief Summary

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

Detailed Description

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Men and women with urinary incontinence (leakage of urine), frequency, and bladder pain experience embarrassment, inconvenience, and a significant negative impact on their quality of life. Although traditional treatments such as medications, diet modification, and bladder training provide relief for some people, others do not experience improvement with these treatments. Recently, mechanical devices much like a heart pacemaker have been developed to stimulate the nerves (sacral and pudendal) responsible for controlling bladder function. During a two stage operation, a permanent electrical wire is implanted in the lower back and connected to a mechanical box (stimulator) implanted under the patients skin in the hip area.

Participants will be asked to complete a set of questionnaires (Intake Form, Urinary Incontinence Treatment Network (UITN) Sexual Activity Questionnaire, Interstitial Cystitis Symptom Index and Problem Index, voiding diary) within 60 days prior to the procedure. Preoperative clinical information such as primary diagnosis, history of failed therapies, and medical history will be collected from the physician office record, and operative information will be collected from the inpatient hospital record. After the two stage operation (3, 6, and 12 months, then yearly thereafter as long as the device is in place) participants will be sent questionnaires. Upon completion and return to the study site

Conditions

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Urinary Retention Urinary Incontinence Pelvic Pain

Keywords

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Urinary Retention Urinary Incontinence Pelvic Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Interstim Neuromodulation

Subjects undergoing implantation of an Interstim device for neuromodulation.

Interstim Neuromodulation

Intervention Type DEVICE

Two stage procedure to implant an interstim device for neuromodulation.

Interventions

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Interstim Neuromodulation

Two stage procedure to implant an interstim device for neuromodulation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role collaborator

Kenneth Peters, MD

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Peters, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2004-073

Identifier Type: -

Identifier Source: org_study_id