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

Primary Purpose

Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor; Insufficiency

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
Sponsored by
Pelvic and Sexual Health Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Bladder Syndrome focused on measuring Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor dysfunction, Fecal incontinence, Constipation, Sexual dysfunction, Dyspareunia, Vulvodynia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pelvic and Sexual Health InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Interstim Parameter Frequency 14 HZ

Interstim Parameter Frequency 40 HZ

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
March 8, 2011
Last Updated
April 28, 2014
Sponsor
Pelvic and Sexual Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01312259
Brief Title
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Official Title
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pelvic and Sexual Health Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: 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). 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: 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). 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interstim Parameter Frequency 14 HZ
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Interstim Parameter Frequency 40 HZ
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis
Other Intervention Name(s)
InterStim, Sacralneuromodulation device, IPG (Implantable pulse generator)
Intervention Description
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 Information:
Title
Improvement in Urinary symptoms and Bladder pain/discomfort
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Improvement in Bowel symptoms and Sexual Function
Description
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).
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Elias, CCRP
Phone
267 479 2387
Email
InterStimStudy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristene E Whitmore, MD
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pelvic and Sexual Health Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Elias, CCRP
Phone
267-479-2397
First Name & Middle Initial & Last Name & Degree
Salim A Wehbe, MD
First Name & Middle Initial & Last Name & Degree
Dominique El Khawand, MD
First Name & Middle Initial & Last Name & Degree
Susan Kellogg, PhD
First Name & Middle Initial & Last Name & Degree
Amy R Hoffmann, MS CRNP
First Name & Middle Initial & Last Name & Degree
Jennifer Fariello, MS CRNP

12. IPD Sharing Statement

Learn more about this trial

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

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