- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441935
InterStim Prospective Database
InterStim Prospective Database for Outcomes Research
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Interstim Neuromodulation
Subjects undergoing implantation of an Interstim device for neuromodulation.
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Two stage procedure to implant an interstim device for neuromodulation.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
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Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
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ScitonCompletedUrinary Incontinence | Stress Urinary Incontinence | Urge IncontinenceUnited States
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Hadassah Medical OrganizationCompletedUrinary Stress Incontinence (SI)Israel
Clinical Trials on Interstim Neuromodulation
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Northwestern UniversityUniversity of Missouri-Columbia; University of Pennsylvania; University of Washington and other collaboratorsCompleted
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William Beaumont HospitalsNot yet recruiting
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Maastricht University Medical CenterMedtronic; Dutch National Health Care InstituteCompletedConstipation | SurgeryNetherlands
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University of AarhusLondon North West Healthcare NHS TrustCompletedFecal IncontinenceDenmark, United Kingdom
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Maastricht University Medical CenterMedtronic; Dutch National Health Care InstituteCompletedConstipation | SurgeryNetherlands
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MedtronicNeuroCompletedFecal Incontinence and ConstipationUnited States, Denmark, Spain, Sweden, Netherlands, Austria, Germany, United Kingdom
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MedtronicNeuroCompletedUrinary Urge IncontinenceNetherlands, United States, Italy, Belgium, Canada, France, United Kingdom
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MedtronicNeuroTerminatedUrinary Incontinence | Detrusor Overactivity | Neurogenic Overactive BladderBelgium, France, United Kingdom, Germany, Italy, Netherlands
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MedtronicNeuroCompletedUrinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)United States