InterStim Prospective Database
| Status: | Terminated |
|---|---|
| Conditions: | Overactive Bladder, Women's Studies, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/27/2017 |
| Start Date: | April 2004 |
| End Date: | December 16, 2016 |
InterStim Prospective Database for Outcomes Research
The study is to collect information from patient charts and patient questionnaires to
evaluate the effects of nerve stimulation therapy on urinary dysfunction.
evaluate the effects of nerve stimulation therapy on urinary dysfunction.
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
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
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:
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