Clinical trial NCT01312259: Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Official title: Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Painful Bladder Syndrome
Interstitial Cystitis
Pelvic Floor; Insufficiency
Bowel Dysfunction
Sexual Dysfunction
Pelvic Floor; Incompetency
Keywords: Painful Bladder Syndrome
Interstitial Cystitis
Pelvic Floor dysfunction
Fecal incontinence
Constipation
Sexual dysfunction
Dyspareunia
Vulvodynia
Lead sponsor: Pelvic and Sexual Health Institute
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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).

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

Primary outcomes:
measure: Improvement in Urinary symptoms and Bladder pain/discomfort
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in Bowel symptoms and Sexual Function
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pelvic and Sexual Health Institute
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Kristene E Whitmore, MD
role: PRINCIPAL_INVESTIGATOR
References: