Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT01455350
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2011-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056650', 'term': 'Vulvodynia'}], 'ancestors': [{'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2011-10-13', 'studyFirstSubmitQcDate': '2011-10-17', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain during intercourse', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated with a visual analog scale'}, {'measure': 'Change in global sexual function', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated with the female sexual function index (FSFI)'}], 'secondaryOutcomes': [{'measure': 'Change in pain catastrophizing', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated using the pain catastrophizing scale'}, {'measure': 'Change in psychologic distress', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated using the State-trait Anxiety Inventory (STAI)'}, {'measure': 'Change in fear of pain', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated using the Pain Anxiety Symptoms Scale (PASS-20)'}, {'measure': 'Change in vulvar blood circulation', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated using a doppler laser'}, {'measure': 'Change in pelvic floor muscles function', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated using transperineal ultrasound and dynamometry'}, {'measure': 'Change in pain sensitivity (pressure pain)', 'timeFrame': 'before treatment, after treatment, 6 months after treatment', 'description': 'evaluated using a vulvagesiometer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['provoked vestibulodynia', 'multimodal physiotherapy', 'lidocaine'], 'conditions': ['Vestibulodynia']}, 'referencesModule': {'references': [{'pmid': '26600287', 'type': 'BACKGROUND', 'citation': 'Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife S, Waddell G, Dubois MF; Provoked vestibulodynia (PVD) Study Group. Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods. Contemp Clin Trials. 2016 Jan;46:52-59. doi: 10.1016/j.cct.2015.11.013. Epub 2015 Nov 18.'}, {'type': 'RESULT', 'citation': 'M. Morin, C. Dumoulin, S. Bergeron, M.H. Mayrand, S. Khalifé, G. Waddell, O. Dubois, M.F. Dubois, PVD Study Group. Randomized controlled trial of multimodal physiotherapy treatment compared to overnight topical lidocaine in women suffering from provoked vestibulodynia. 40th Annual Meeting of the International Urogynecological Association, Nice, France, 2015, Int Urogynecol J, 1(Supp - June 2015), PP22.'}, {'pmid': '32818475', 'type': 'DERIVED', 'citation': 'Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife S, Waddell G, Dubois MF; PVD Study Group. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021 Feb;224(2):189.e1-189.e12. doi: 10.1016/j.ajog.2020.08.038. Epub 2020 Aug 18.'}, {'pmid': '32434709', 'type': 'DERIVED', 'citation': 'Benoit-Piau J, Dumoulin C, Carroll MS, Mayrand MH, Bergeron S, Khalife S, Waddell G, Morin M; Provoked Vestibulodynia (PVD) Study Group. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med. 2020 Jul;17(7):1304-1311. doi: 10.1016/j.jsxm.2020.04.005. Epub 2020 May 17.'}]}, 'descriptionModule': {'briefSummary': 'Chronic gynaecological pain is a major medical problem that affects 20-30% of women at different moments of their life. This largely neglected issue has a significant impact on the sexual and conjugal life of women suffering from it as well as on their psychological health. Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally ignored. Also, treatment is limited and not extensively studied. This study aims at better understanding and treating gynaecological pain. The focus of the study will be provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital, Royal-Victoria Hospital, CHUM St-Luc).', 'detailedDescription': "This is a randomised controlled trial comparing the impact of multimodal physiotherapy treatments to topical lidocaine in women suffering from provoked vestibulodyina. The first treatment consists of 10 sixty minutes weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises. The second treatment is a night time application of lidocaine to the vulva for 10 weeks. Physiotherapists will then evaluate women's pain and sexual function right after the treatment and 6 months later."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe pain in at least 90% of sexual intercourses.\n* Moderate to severe pain during the cotton-swab test at one of more vestibule regions (5/10 minimum pain evaluation on the verbal pain intensity scale).\n* Pain limited to the vestibule during vaginal penetrations and during activities applying pressure on the vestibule.\n* Provoked vestibulodynia lasting at least 6 months prior to the study and diagnosed by a standardised gynaecologic exam protocol by one of our collaborator.\n\nExclusion Criteria:\n\n* Major psychiatric condition or pelvic pathology associated with a genital pain problem (e.g.: dyspareunia).\n* Use of medication that could influence pain perception.\n* Actual or past pregnancy.\n* Vulvar or vaginal surgery\n* Post-menopausal state\n* Unwillingness to restrain from other treatments till the 6 months post-treatment evaluation.\n* Urogynaecologic symptoms (urinary/anal incontinence, pelvic organs prolapsus, urinary/vaginal infection active or during the last 3 months).\n* Incapacity to have sexual intercourse including vaginal penetration during the last 6 months.\n* Physiotherapy treatments or lidocaine application prior to the study'}, 'identificationModule': {'nctId': 'NCT01455350', 'briefTitle': 'Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine', 'orgStudyIdInfo': {'id': 'MOP-115028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': '10 week treatment of daily application of topical lidocaine', 'interventionNames': ['Drug: lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Multimodal physiotherapy', 'description': '10 weeks of weekly multimodal physiotherapy treatments', 'interventionNames': ['Procedure: Multimodal physiotherapy']}], 'interventions': [{'name': 'Multimodal physiotherapy', 'type': 'PROCEDURE', 'description': '10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.', 'armGroupLabels': ['Multimodal physiotherapy']}, {'name': 'lidocaine', 'type': 'DRUG', 'otherNames': ['Xylocaine'], 'description': '10 weeks of daily topical 5% lidocaine application', 'armGroupLabels': ['Lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3C 3T5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Melanie Morin, Pht, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist, PhD', 'investigatorFullName': 'Mélanie Morin', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}