InterStim Prospective Database

Sponsor

Kenneth Peters, MD (Other)

Overall Status

Terminated

CT.gov ID

NCT00441935

Collaborator

William Beaumont Hospitals (Other)

736

Enrollment

Location

152.5

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Urinary Incontinence Pelvic Pain	Device: Interstim Neuromodulation

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

736 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

InterStim Prospective Database for Outcomes Research

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Dec 16, 2016

Actual Study Completion Date :

Dec 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Interstim Neuromodulation Subjects undergoing implantation of an Interstim device for neuromodulation.	Device: Interstim Neuromodulation Two stage procedure to implant an interstim device for neuromodulation.

Arm

Intervention/Treatment

Interstim Neuromodulation

Subjects undergoing implantation of an Interstim device for neuromodulation.

Device: Interstim Neuromodulation

Two stage procedure to implant an interstim device for neuromodulation.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.