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

Sponsor
Pelvic and Sexual Health Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT01312259
Collaborator
(none)
72
1
2
84
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
Phase 4

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Study Start Date :
Apr 1, 2011
Anticipated Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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)
  • Outcome Measures

    Primary Outcome Measures

    1. Improvement in Urinary symptoms and Bladder pain/discomfort [1 year]

      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

    1. Improvement in Bowel symptoms and Sexual Function [1 year]

      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 Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Pelvic and Sexual Health Institute Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Pelvic and Sexual Health Institute

    Investigators

    • Principal Investigator: Kristene E Whitmore, MD, Drexel University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristene Whitmore, M.D., Medical Director, Pelvic and Sexual Health Institute
    ClinicalTrials.gov Identifier:
    NCT01312259
    Other Study ID Numbers:
    • 19522
    First Posted:
    Mar 10, 2011
    Last Update Posted:
    Apr 29, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by Kristene Whitmore, M.D., Medical Director, Pelvic and Sexual Health Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2014