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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 28, 2014
Last verified: April 2014
  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 of '' Frequency" in patients with Interstitial Cystitis
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:


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 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Interstim Parameter Frequency 14 HZ
Subjects in this arm will receive 14 Hx as their frequency for the first three months. For the second 3 months, these patients will receive 40 Hz. Six months after the devise has been implanted, the patient has the option to choose which frequency they feel allows for better symptom control, and this is how the devise will be programmed.
Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
Subjects will be randomized into one of two groups. Group One will be programmed to receive 14 Hz as their frequency, while the other group (Group 2) will receive 40 Hz as their frequency for the first ninety days after surgical implantation. After three months each patient will come in to the office to have their InterStim frequency changed to the opposite frequency. After each patient has had three months to evaluate each of the two frequencies, the next step is to allow the patient to decide which setting they thought best controlled their respective symptoms. The InterStim was then programed to whichever frequency the patient chose, and this would remain for three to six months.
Other Names:
  • InterStim
  • Sacralneuromodulation device
  • IPG (Implantable pulse generator)
Experimental: Interstim Parameter Frequency 40 HZ
Subjects in this arm will receive 40 Hz as their frequency for the first three months. For the second 3 months, these patients will receive 14 Hz. Six months after the devise has been implanted, the patient has the option to choose which frequency they feel allows for better symptom control, and this is how the devise will be programmed.
Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
Subjects will be randomized into one of two groups. Group One will be programmed to receive 14 Hz as their frequency, while the other group (Group 2) will receive 40 Hz as their frequency for the first ninety days after surgical implantation. After three months each patient will come in to the office to have their InterStim frequency changed to the opposite frequency. After each patient has had three months to evaluate each of the two frequencies, the next step is to allow the patient to decide which setting they thought best controlled their respective symptoms. The InterStim was then programed to whichever frequency the patient chose, and this would remain for three to six months.
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
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: 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: April 28, 2014
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, Interstitial
Cystitis
Intestinal Diseases
Gastrointestinal Diseases
Pain
Urinary Bladder Diseases
Urologic Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014