InterStim Prospective Database

Urinary Incontinence Clinical Trial

Official title:

InterStim Prospective Database for Outcomes Research

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00441935
• Other study ID #: 2004-073
• Status: Terminated
• Phase: N/A
• First received: February 28, 2007
• Last updated: December 21, 2017
• Start date: April 2004
• Est. completion date: December 16, 2016

Study information

• Verified date: December 2017
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 736
• Est. completion date: December 16, 2016
• Est. primary completion date: December 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Enuresis
• Pelvic Pain
• Urinary Incontinence
• Urinary Retention

Intervention

Device:
• Interstim Neuromodulation
Two stage procedure to implant an interstim device for neuromodulation.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Peters, MD	William Beaumont Hospitals

Country where clinical trial is conducted

United States,