Sacral Neuromodulation in Patients With IC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Drexel University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Philadelphia Urosurgical Associates
Medtronic
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00590473
First received: December 26, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

The hypothesis for this study is that bilateral sacral neuromodulation will improve symptoms of interstitial cystitis by at least 25% when compared to unilateral sacral neuromodulation as reported by patient's responses to the Interstitial Cystitis Symptom and Problem Indices.

This study will be a prospective randomized study comparing bilateral to unilateral sacral neuromodulation. The study population will include all patients diagnosed with interstitial cystitis, using the NIDDK criteria, having staged sacral neuromodulator stimulators placed at Hahnemann University Hospital.


Condition Intervention
Interstitial Cystitis
Device: Interstim

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sacral Neuromodulation: Bilateral Placement vs. Unilateral Placement in Patients With Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • To determine if bilateral sacral neuromodulation will reduce the patient's score on the Interstitial Cystitis Symptom and Problem Questionnaire by at least 25% when compared to unilateral sacral neuromodulation in patients with interstitial cystitis. [ Time Frame: Post-op, at 6 weeks and at 3 months post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if bilateral sacral neuromodulation will improve the patient's voiding diary defined as reduction in urinary frequency by 25% from baseline when compared to unilateral sacral neuromodulation in patients with interstitial cystitis [ Time Frame: Post-op, at 6 weeks and 3 months post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Unilateral Placement of Interstim IPG
Device: Interstim
Unilateral vs. Bilateral Placement of Interstim IPG
Active Comparator: 2
Bilateral Placement of Interstim IPG
Device: Interstim
Unilateral vs. Bilateral Placement of Interstim IPG

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Diagnosis of interstitial cystitis for at least 6 months.
  • At least 18yrs old and less than 80.
  • Symptoms of urgency (>4 on the visual analog scale).
  • Symptoms of urinary frequency (>8 episodes/day as recorded on a voiding diary)
  • Symptoms of pelvic pain (>4 on the visual analog scale for pelvic pain).
  • Interstitial Cystitis refractory to more conservative treatments such as behavioral modification, dietary intervention, or medical therapy for at least 6 months.
  • Able to make medical decisions for herself.
  • Presence of either glomerulations of Hunner's ulcer on cystoscopic examination.
  • Participant must agree to use a medically acceptable method of contraception throughout the entire study period, and for 7 days after the study period. Medically acceptable methods of contraception include abstinence, birth control pills or patches, diaphragm with spermicide, IUD, condom with vaginal spermicide, surgical sterilization, post menopausal for at least 1 year, implants or injections, or vasectomized partner.
  • Must give written informed consent to participate in this study.

Exclusion Criteria:

  • Prior sacral neuromodulation.
  • Participant is currently pregnant or breastfeeding.
  • Male.
  • Urinary retention (defined by post void residual greater than 100cc).
  • Neurologic deficit.
  • Need for future MRI surveillance.
  • Involved in any study within the past thirty days or currently enrolled.
  • Presence of bladder or ureteral calculi.
  • Active genital herpes.
  • Uterine, cervical, vaginal, or urethral cancer.
  • Urethral diverticulum.
  • Cyclophosphamide cystitis.
  • Vaginitis.
  • Tuberculous cystitis.
  • Foreign body within the bladder (indwelling catheter- foley or suprapubic tube, or ureteral stent).
  • An employee or a relative of an employee of Medtronic Inc. or The Pelvic and Sexual Health Institute.
  • Bladder capacity greater than 350 cc while awake during cystometrogram.
  • Duration of symptoms of less than 6 months.
  • Detrusor overactivity on cystometrogram.
  • Absence of nocturia, defined by greater than 2 voids per sleeping hours.
  • Urinary symptoms relieved by either antimicrobials, antiseptics, anticholinergics, or antispasmodics.
  • Urinary frequency of less than 8 voids per day.
  • Diagnosis of bacterial cystitis or prostatitis within the past 3 months.
  • Radiation cystitis.
  • Benign or malignant bladder tumors.
  • Age less than 18 or greater than 79.
  • Participant is currently receiving or has received pelvic radiation.
  • Participant is diagnosed with cancer within the past 5 years prior to the start of the study.
  • Participant has a history of alcohol or substance abuse within the past 5 years prior to the start of the study.
  • Severe or uncontrolled diabetes or diabetes with peripheral nerve involvement.
  • Patients with implanted electrical devices (cardiac pacemakers or defibrillators).
  • Patients on anticoagulation therapy.
  • Planned future exposure to diathermy, microwave, or RF energy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590473

Contacts
Contact: Sandra L. Mosiniak 267-479-2397 smosiniak@yahoo.com

Locations
United States, Pennsylvania
Pelvic and Sexual Health Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Kristene E. Whitmore, M.D.         
Sponsors and Collaborators
Drexel University
Philadelphia Urosurgical Associates
Medtronic
Investigators
Principal Investigator: Kristene E. Whitmore, M.D. Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Kristene E. Whitmore, M.D./President, Philadelphia Urosurgical Associates
ClinicalTrials.gov Identifier: NCT00590473     History of Changes
Other Study ID Numbers: 71692
Study First Received: December 26, 2007
Last Updated: December 26, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Drexel University:
Interstitial Cystitis
IC
Neuromodulation
Interstim Therapy

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014