Recruiting

InterStim®

Sponsor:

Pelvic and Sexual Health Institute

Code:

NCT01312259

Conditions

Painful Bladder Syndrome

Interstitial Cystitis

Pelvic Floor; Insufficiency

Bowel Dysfunction

Sexual Dysfunction

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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).

Conditions

Painful Bladder Syndrome

Interstitial Cystitis

Pelvic Floor; Insufficiency

Bowel Dysfunction

Sexual Dysfunction

Study ID

NCT01312259

Start date

Apr, 2011

Status verified date

Apr, 2014

Completion date

Apr, 2018

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Improvement in Urinary symptoms and Bladder pain/discomfort [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Elizabeth Elias, CCRP

267 479 2387InterStimStudy@yahoo.com

Locations

Pelvic and Sexual Health Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Elizabeth Elias, CCRP

267-479-2397

More Information

Sponsor

Pelvic and Sexual Health Institute

Last update posted

Apr 29, 2014

Last verified

Apr, 2014

Keywords

  • Painful Bladder Syndrome
  • Interstitial Cystitis
  • Pelvic Floor dysfunction
  • Fecal incontinence
  • Constipation
  • Sexual dysfunction
  • Dyspareunia
  • Vulvodynia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pelvic and Sexual Health Institute on 2014-04-29.