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

Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01312259
• Other study ID #: 19522
• Status: Recruiting
• Phase: Phase 4
• First received: March 8, 2011
• Last updated: April 28, 2014
• Start date: April 2011
• Est. completion date: April 2018

Study information

• Verified date: April 2014
• Source: Pelvic and Sexual Health Institute
• Contact: Elizabeth Elias, CCRP
• Phone: 267 479 2387
• Email: InterStimStudy[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Dysfunction
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Intestinal Diseases
• Pain
• Painful Bladder Syndrome
• Pelvic Floor; Incompetency
• Pelvic Floor; Insufficiency
• Sexual Dysfunction
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Pelvic and Sexual Health Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pelvic and Sexual Health Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No