InterStim Prospective Database

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00441935
First received: February 28, 2007
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Urinary Retention
Urinary Incontinence
Pelvic Pain
Device: Interstim Neuromodulation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: InterStim Prospective Database for Outcomes Research

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Estimated Enrollment: 3000
Study Start Date: April 2004
Estimated Study Completion Date: April 2029
Estimated Primary Completion Date: April 2029 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Interstim Neuromodulation
Subjects undergoing implantation of an Interstim device for neuromodulation.
Device: Interstim Neuromodulation
Two stage procedure to implant an interstim device for 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441935

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00441935     History of Changes
Other Study ID Numbers: 2004-073
Study First Received: February 28, 2007
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Urinary Retention
Urinary Incontinence
Pelvic Pain

Additional relevant MeSH terms:
Urinary Incontinence
Pelvic Pain
Urinary Retention
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on September 18, 2014