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

NCT ID: NCT01312259

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2018-04-30

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).

Conditions

Painful Bladder Syndrome; Interstitial Cystitis; Pelvic Floor; Insufficiency; Bowel Dysfunction; Sexual Dysfunction; Pelvic Floor; Incompetency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

InterStim; Sacralneuromodulation device; IPG (Implantable pulse generator)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pelvic and Sexual Health Institute

OTHER

Sponsor Role: lead

Responsible Party

Kristene Whitmore, M.D.

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristene E Whitmore, MD

Role: PRINCIPAL_INVESTIGATOR

Drexel University College of Medicine

Locations

Pelvic and Sexual Health Institute

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Elias, CCRP

Role: CONTACT

InterStimStudy@yahoo.com

267 479 2387

Facility Contacts

Elizabeth Elias, CCRP

Role: primary

267-479-2397

Other Identifiers

19522

Identifier Type: -

Identifier Source: org_study_id