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Purpose:
Purpose:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interstim Parameter Frequency 14 HZ | Active Comparator | 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. |
|
| Interstim Parameter Frequency 40 HZ | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Changing the Interstim parameter of '' Frequency" in patients with Interstitial Cystitis | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Elias, CCRP | Contact | 267 479 2387 | InterStimStudy@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Kristene E Whitmore, MD | Drexel University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pelvic and Sexual Health Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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|
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| D007410 | Intestinal Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D005242 | Fecal Incontinence |
| D003248 | Constipation |
| D004414 | Dyspareunia |
| D056650 | Vulvodynia |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000091662 | Genital Diseases |
| D012002 | Rectal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D005832 | Genital Diseases, Male |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D014845 | Vulvar Diseases |
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