NCT00441935

InterStim Prospective Database

InterStim Prospective Database for Outcomes Research

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 736 (actual)
• Sponsor: Kenneth Peters, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Urinary Retention
• Urinary Incontinence
• Pelvic Pain

Interventions

Type	Name	Description
DEVICE	Interstim Neuromodulation	Two stage procedure to implant an interstim device for neuromodulation.

Timeline

• Start date: 2004-04-01
• Primary completion: 2016-12-16
• Completion: 2016-12-16
• First posted: 2007-03-01
• Last updated: 2017-12-26

Locations

1 site across 1 country: United States