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

Phase 4

• Conditions: Pelvic Floor; Insufficiency; Bowel Dysfunction; Painful Bladder Syndrome; Sexual Dysfunction; Interstitial Cystitis; Pelvic Floor; Incompetency
• Interventions: Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis

• Registration Number: NCT01312259
• Lead Sponsor: Pelvic and Sexual Health Institute

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).

Study Timeline

• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-10
• Study Start: 2011-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-28
• Last Update Posted: 2014-04-29
• Primary Completion: 2017-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Interstim Parameter Frequency 14 HZ	Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis	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.
Interstim Parameter Frequency 40 HZ	Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Pelvic and Sexual Health Institute; 🇺🇸 Philadelphia, Pennsylvania, United States