Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Status unconfirmed · Phase 4
Conditions studied: Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor; Insufficiency, Bowel Dysfunction, Sexual Dysfunction, Pelvic Floor; Incompetency
In brief
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).
Key facts
- Study ID
- NCT01312259
- Run by
- Pelvic and Sexual Health Institute
- People needed
- 72
- Starts
- 2011-04-01
- Expected to finish
- 2018-04-01
- Last updated by the study team
- 2014-04-29
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Pelvic and Sexual Health Institute — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.