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

March 8, 2011
April 28, 2014
April 2011
April 2017   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01312259 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome

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).

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).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
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)
  • 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.
    Intervention: Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
  • 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.
    Intervention: Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
April 2018
April 2017   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Elizabeth Elias, CCRP 267 479 2387 InterStimStudy@yahoo.com
United States
 
NCT01312259
19522
No
Kristene Whitmore, M.D., Pelvic and Sexual Health Institute
Pelvic and Sexual Health Institute
Not Provided
Principal Investigator: Kristene E Whitmore, MD Drexel University College of Medicine
Pelvic and Sexual Health Institute
April 2014

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