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Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome

This study is currently recruiting participants.
Verified December 2011 by Pelvic and Sexual Health Institute
Sponsor:
Information provided by (Responsible Party):
Kristene Whitmore, M.D., Pelvic and Sexual Health Institute
ClinicalTrials.gov Identifier:
NCT01312259
First received: March 8, 2011
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

Purpose:

  1. To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
  2. The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).

Condition Intervention Phase
Painful Bladder Syndrome
Interstitial Cystitis
Pelvic Floor; Insufficiency
Bowel Dysfunction
Sexual Dysfunction
Pelvic Floor; Incompetency
 Other: Changing the Interstim parameter '' Frequency"
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pelvic and Sexual Health Institute:

Primary Outcome Measures:
  • Improvement in Urinary symptoms and Bladder pain/discomfort [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).


Secondary Outcome Measures:
  • Improvement in Bowel symptoms and Sexual Function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).


Estimated Enrollment: 72
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interstim Parameter Frequency 14 HZ
Subjects in this arm are maintained on standard Frequency of 14 Hz with continuous stimulation.
 Other: Changing the Interstim parameter '' Frequency"
Subjects will be randomized to receive either 14 HZ or 40 HZ continuous stimulation
Other Names:
  • InterStim
  • Sacralneuromodulation device
  • IPG (Implantable pulse generator)
Experimental: Interstim Parameter Frequency 40 HZ
Subjects in this arm are randomized to receive an experimental frequency with the Interstim of 40 HZ , with continuous stimulation.
 Other: Changing the Interstim parameter '' Frequency"
Subjects will be randomized to receive either 14 HZ or 40 HZ continuous stimulation
Other Names:
  • InterStim
  • Sacralneuromodulation device
  • IPG (Implantable pulse generator)

Detailed Description:

Purpose:

  1. Primary: to demonstrate better symptoms control (pain, urinary urgency and frequency) with sacral neuromodulation (SNM) in patients with interstitial cystitis /painful bladder syndrome (IC/PBS) using a stimulation frequency of 40 hertz (experimental) compared to a frequency of 14 hertz (standard).
  2. Secondary: The evaluate the efficacy of the two frequency settings on the other associated conditions that often coexist in patients with IC/PBS, such as female sexual dysfunction (FSD), bowel dysfunction, high tone pelvic floor dysfunction (HTPFD, painful spasm of the pelvic floor muscles), Vulvodynia (pain at the opening of the vagina).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female with diagnosis of IC/PBS with implanted IPG Interstim.
  • Scores > 8 on the Interstitial Cystitis Symptom index questionnaire (ICSI) and > 8 on the Interstitial Cystitis Problem Index questionnaire (ICPI).
  • Signed Informed Consent.

Exclusion Criteria:

  • Progressive neurologic disease or peripheral neuropathy.
  • History of bladder surgery.
  • Subjects implanted with other neuromodulation device.
  • Current or planning pregnancy; Breastfeeding.
  • Subjects who are not deemed able to fill questionnaires
  • Mental illness or mentally unstable patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312259

Contacts
Contact: Elizabeth Elias, CCRP 267 479 2387 InterStimStudy@yahoo.com

Locations
United States, Pennsylvania
Pelvic and Sexual Health Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Elizabeth Elias, CCRP     267-479-2397        
Sub-Investigator: Salim A Wehbe, MD            
Sub-Investigator: Dominique El Khawand, MD            
Sub-Investigator: Susan Kellogg, PhD            
Sub-Investigator: Amy R Hoffmann, MS CRNP            
Sub-Investigator: Jennifer Fariello, MS CRNP            
Sponsors and Collaborators
Pelvic and Sexual Health Institute
Investigators
Principal Investigator: Kristene E Whitmore, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Kristene Whitmore, M.D., Medical Director, Pelvic and Sexual Health Institute
ClinicalTrials.gov Identifier: NCT01312259     History of Changes
Other Study ID Numbers: 19522
Study First Received: March 8, 2011
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Pelvic and Sexual Health Institute:
Painful Bladder Syndrome
Interstitial Cystitis
Pelvic Floor dysfunction
Fecal incontinence
 Constipation
Sexual dysfunction
Dyspareunia
Vulvodynia

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Intestinal Diseases
Gastrointestinal Diseases
Pain
Sexual Dysfunctions, Psychological
Urinary Bladder Diseases
 Urologic Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013