Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-11 @ 7:55 PM
Study NCT ID:
NCT01811602
Status:
UNKNOWN
Last Update Posted:
2015-04-13
First Post:
2013-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gynecological Pelvic Floor Muscle Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-10', 'studyFirstSubmitDate': '2013-03-12', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary incontinence', 'timeFrame': '12 weeks', 'description': 'Urinary incontinence, measured using the International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI Short Form) and bladder diary'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Training', 'Physiotherapy', 'Pelvic floor muscles'], 'conditions': ['Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years\n\nExclusion Criteria:\n\n* stage IV cancer or stage III and IV cervical cancer\n* radiation not part of treatment\n* known spinal or long bone metastases diagnosis with a neuromuscular disorder that may impact pelvic floor muscle function\n* urinary incontinence issues prior to cancer diagnosis\n* scheduled or previous surgical treatment of incontinence\n* fecal incontinence\n* body mass index (BMI) \\> 35\n* use of medications to improve bladder function\n* unable to complete questionnaires in English or unable to actively participate in physiotherapy treatment provided in English.'}, 'identificationModule': {'nctId': 'NCT01811602', 'briefTitle': 'Gynecological Pelvic Floor Muscle Training', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study', 'orgStudyIdInfo': {'id': 'H12-02473'}, 'secondaryIdInfos': [{'id': 'F12-00262', 'type': 'OTHER_GRANT', 'domain': 'Physiotherapy Foundation of Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Training', 'description': 'Pelvic floor muscle training delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction', 'interventionNames': ['Other: Training']}, {'type': 'OTHER', 'label': 'Usual Care Control', 'description': 'Participants randomized to this arm will receive a 1-page educational pamphlet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Training', 'type': 'OTHER', 'otherNames': ['Pelvic Floor Muscle Training'], 'description': 'The participants randomized to the pelvic floor muscle training intervention will receive pelvic floor muscle training (0-12 weeks) delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction. The intervention is 9 individual, one-on-one, 45-minute sessions; weekly for weeks 0-6 and bi-weekly for weeks 7-12 (first session will be 60 minutes). The sessions will provide pelvic floor muscle training based on the latest evidence, including biofeedback, to teach the correct technique for pelvic floor contractions, and participants will be asked to complete daily pelvic floor exercises at home.', 'armGroupLabels': ['Training']}, {'name': 'Usual Care', 'type': 'OTHER', 'otherNames': ['Educational pamphlet'], 'description': 'The participants randomized to the educational pamphlet intervention (usual care control) will receive a 1-page sheet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.', 'armGroupLabels': ['Usual Care Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Pat Lieblich, PT', 'role': 'CONTACT', 'email': 'plieblich@cw.bc.ca'}], 'facility': "Women's Health Centre", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Kristin Campbell, PhD', 'role': 'CONTACT', 'email': 'kristin.campbell@ubc.ca', 'phone': '604-827-4704'}, {'name': 'Sarah Finlayson', 'role': 'CONTACT', 'email': 'Sarah.Finlayson@vch.ca', 'phone': '604-877-6000', 'phoneExt': '2367'}], 'overallOfficials': [{'name': 'Kristin Campbell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}