Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 9:57 AM
Study NCT ID:
NCT01312259
Status:
UNKNOWN
Last Update Posted:
2014-04-29
First Post:
2011-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D004414', 'term': 'Dyspareunia'}, {'id': 'D056650', 'term': 'Vulvodynia'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2011-03-08', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Urinary symptoms and Bladder pain/discomfort', 'timeFrame': '1 year', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Improvement in Bowel symptoms and Sexual Function', 'timeFrame': '1 year', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Painful Bladder Syndrome', 'Interstitial Cystitis', 'Pelvic Floor dysfunction', 'Fecal incontinence', 'Constipation', 'Sexual dysfunction', 'Dyspareunia', 'Vulvodynia'], 'conditions': ['Painful Bladder Syndrome', 'Interstitial Cystitis', 'Pelvic Floor; Insufficiency', 'Bowel Dysfunction', 'Sexual Dysfunction', 'Pelvic Floor; Incompetency']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\n1. 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).\n2. 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).', 'detailedDescription': 'Purpose:\n\n1. 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).\n2. 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female with diagnosis of IC/PBS with implanted IPG Interstim.\n* Scores \\> 8 on the Interstitial Cystitis Symptom index questionnaire (ICSI) and \\> 8 on the Interstitial Cystitis Problem Index questionnaire (ICPI).\n* Signed Informed Consent.\n\nExclusion Criteria:\n\n* Progressive neurologic disease or peripheral neuropathy.\n* History of bladder surgery.\n* Subjects implanted with other neuromodulation device.\n* Current or planning pregnancy; Breastfeeding.\n* Subjects who are not deemed able to fill questionnaires\n* Mental illness or mentally unstable patients'}, 'identificationModule': {'nctId': 'NCT01312259', 'briefTitle': 'Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Pelvic and Sexual Health Institute'}, 'officialTitle': 'Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome', 'orgStudyIdInfo': {'id': '19522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interstim Parameter Frequency 14 HZ', '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.', 'interventionNames': ['Other: Changing the Interstim parameter of \'\' Frequency" in patients with Interstitial Cystitis']}, {'type': 'EXPERIMENTAL', 'label': 'Interstim Parameter Frequency 40 HZ', '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.', 'interventionNames': ['Other: Changing the Interstim parameter of \'\' Frequency" in patients with Interstitial Cystitis']}], 'interventions': [{'name': 'Changing the Interstim parameter of \'\' Frequency" in patients with Interstitial Cystitis', 'type': 'OTHER', 'otherNames': ['InterStim', 'Sacralneuromodulation device', 'IPG (Implantable pulse generator)'], 'description': '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.', 'armGroupLabels': ['Interstim Parameter Frequency 14 HZ', 'Interstim Parameter Frequency 40 HZ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Elias, CCRP', 'role': 'CONTACT', 'phone': '267-479-2397'}, {'name': 'Salim A Wehbe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dominique El Khawand, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Susan Kellogg, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amy R Hoffmann, MS CRNP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jennifer Fariello, MS CRNP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pelvic and Sexual Health Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Elizabeth Elias, CCRP', 'role': 'CONTACT', 'email': 'InterStimStudy@yahoo.com', 'phone': '267 479 2387'}], 'overallOfficials': [{'name': 'Kristene E Whitmore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pelvic and Sexual Health Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Kristene Whitmore, M.D.', 'investigatorAffiliation': 'Pelvic and Sexual Health Institute'}}}}