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

Pelvic and Sexual Health Institute

Status and phase: Unknown; Phase 4

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01312259

19522

Details and patient eligibility

About

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).

Full 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).

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Interstim Parameter Frequency 14 HZ

Active Comparator group

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.

Treatment:

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

Interstim Parameter Frequency 40 HZ

Experimental group

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.

Treatment:

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