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

NCT01312259 | Unknown Phase 4

• 1 other identifier: 19522
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose:

1. 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. 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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in Bowel symptoms and Sexual Function

  1 year

Study Arms (2)

Interstim Parameter Frequency 14 HZ

ACTIVE COMPARATOR

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

Interstim Parameter Frequency 40 HZ

EXPERIMENTAL

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

Interventions

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

Also known as: InterStim, Sacralneuromodulation device, IPG (Implantable pulse generator)

Interstim Parameter Frequency 14 HZ; Interstim Parameter Frequency 40 HZ

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pelvic and Sexual Health Institute: lead

Study Sites (1)

Pelvic and Sexual Health Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial; Intestinal Diseases; Sexual Dysfunction, Physiological; Fecal Incontinence; Constipation; Dyspareunia; Vulvodynia

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Genital Diseases, Male; Sexual Dysfunctions, Psychological; Mental Disorders; Vulvar Diseases

Study Officials

• Kristene E Whitmore, MD

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Elias, CCRP

CONTACT

267 479 2387; InterStimStudy@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

US (1)