Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Painful Bladder Syndrome
- Sponsor
- Pelvic and Sexual Health Institute
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Improvement in Urinary symptoms and Bladder pain/discomfort
- Last Updated
- 12 years ago
Overview
Brief Summary
Purpose:
- 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).
- 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).
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).
Investigators
Kristene Whitmore, M.D.
Medical Director
Pelvic and Sexual Health Institute
Eligibility 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
Outcomes
Primary Outcomes
Improvement in Urinary symptoms and Bladder pain/discomfort
Time Frame: 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 Outcomes
- Improvement in Bowel symptoms and Sexual Function(1 year)