Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Constipation, Other Indications, Psychiatric, Gastrointestinal, Pain, Urology |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal, Nephrology / Urology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | April 2011 |
| End Date: | April 2018 |
| Contact: | Elizabeth Elias, CCRP |
| Email: | InterStimStudy@yahoo.com |
| Phone: | 267 479 2387 |
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).
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).
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).
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).
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
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