Sexual Dysfunction Clinical Trial
Official title:
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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