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).

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Pelvic and Sexual Health Institute
      • Contact: Elizabeth Elias, CCRP; Phone Number: 267-479-2397
      • Sub-Investigator: Salim A Wehbe, MD
      • Sub-Investigator: Dominique El Khawand, MD
      • Sub-Investigator: Susan Kellogg, PhD
      • Sub-Investigator: Amy R Hoffmann, MS CRNP
      • Sub-Investigator: Jennifer Fariello, MS CRNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Interstim Parameter Frequency 14 HZ; 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.	Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis; Subjects will be randomized into one of two groups. Group One will be programmed to receive 14 Hz as their frequency, while the other group (Group 2) will receive 40 Hz as their frequency for the first ninety days after surgical implantation. After three months each patient will come in to the office to have their InterStim frequency changed to the opposite frequency. After each patient has had three months to evaluate each of the two frequencies, the next step is to allow the patient to decide which setting they thought best controlled their respective symptoms. The InterStim was then programed to whichever frequency the patient chose, and this would remain for three to six months.; Other Names: InterStim; Sacralneuromodulation device; IPG (Implantable pulse generator)
EXPERIMENTAL: Interstim Parameter Frequency 40 HZ; 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.	Other: Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis; Subjects will be randomized into one of two groups. Group One will be programmed to receive 14 Hz as their frequency, while the other group (Group 2) will receive 40 Hz as their frequency for the first ninety days after surgical implantation. After three months each patient will come in to the office to have their InterStim frequency changed to the opposite frequency. After each patient has had three months to evaluate each of the two frequencies, the next step is to allow the patient to decide which setting they thought best controlled their respective symptoms. The InterStim was then programed to whichever frequency the patient chose, and this would remain for three to six months.; Other Names: InterStim; Sacralneuromodulation device; IPG (Implantable pulse generator)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Urinary symptoms and Bladder pain/discomfort	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Bowel symptoms and Sexual Function	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).	1 year

Collaborators and Investigators

• Sponsor: Pelvic and Sexual Health Institute
• Investigators: Principal Investigator: Kristene E Whitmore, MD, Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ANTICIPATED): April 1, 2017
• Study Completion (ANTICIPATED): April 1, 2018

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (ESTIMATE): March 10, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 28, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Constipation; Fecal incontinence; Interstitial Cystitis; Painful Bladder Syndrome; Dyspareunia; Sexual dysfunction; Vulvodynia; Pelvic Floor dysfunction
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Disease; Gastrointestinal Diseases; Syndrome; Cystitis; Pain; Intestinal Diseases; Cystitis, Interstitial
• Other Study ID Numbers: 19522