Sacral Neuromodulation in Patients With IC

April 7, 2017 updated by: Drexel University College of Medicine

Sacral Neuromodulation: Bilateral Placement vs. Unilateral Placement in Patients With Interstitial Cystitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pelvic and Sexual Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Post-op, at 6 weeks and at 3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Post-op, at 6 weeks and 3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Drexel University College of Medicine

Collaborators

Medtronic

Investigators

  • Principal Investigator: Kristene E. Whitmore, M.D., Drexel University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71692

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.

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