Bowel Dysfunction, Interstitial Cystitis, Painful Bladder Syndrome, Pelvic Floor; Incompetency, Pelvic Floor; Insufficiency, Sexual Dysfunction
Conditions
Keywords
Painful Bladder Syndrome, Interstitial Cystitis, Pelvic Floor dysfunction, Fecal incontinence, Constipation, Sexual dysfunction, Dyspareunia, Vulvodynia
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).
Detailed 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).
Interventions
OTHERChanging 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.
Sponsors
Pelvic and Sexual Health Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Urinary symptoms and Bladder pain/discomfort | 1 year | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Bowel symptoms and Sexual Function | 1 year | 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). |
Countries
United States
Contacts
Primary ContactElizabeth Elias, CCRP
Outcome results
None listed