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

Study Overview
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Brief Summary
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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
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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).

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

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

Intervention / Treatment
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* Other: Changing the Interstim parameter of '' Frequency in patients with Interstitial Cystitis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interstim Parameter Frequency 14 HZ<br>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<br>* 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.<br>* Other names: IPG (Implantable pulse generator);|
| Experimental: Interstim Parameter Frequency 40 HZ<br>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<br>* 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.<br>* Other names: IPG (Implantable pulse generator);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor dysfunction, Fecal incontinence, Constipation, Sexual dysfunction, Dyspareunia, Vulvodynia