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

February 28, 2007
May 12, 2014
April 2004
April 2029   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00441935 on ClinicalTrials.gov Archive Site
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InterStim Prospective Database
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.

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

Observational
Time Perspective: Prospective
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Non-Probability Sample

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

  • Urinary Retention
  • Urinary Incontinence
  • Pelvic Pain
Device: Interstim Neuromodulation
Two stage procedure to implant an interstim device for neuromodulation.
Interstim Neuromodulation
Subjects undergoing implantation of an Interstim device for neuromodulation.
Intervention: Device: Interstim Neuromodulation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
3000
April 2029
April 2029   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00441935
2004-073
No
Kenneth Peters, MD, William Beaumont Hospitals
Kenneth Peters, MD
William Beaumont Hospitals
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
William Beaumont Hospitals
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP