Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 6:09 AM
Study NCT ID:
NCT06760767
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052065', 'term': 'Vaginismus'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2024-12-30', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface Electromyography (sEMG)', 'timeFrame': '0-6 weeks', 'description': 'A 2-channel Neurotrac MyoPlus 4 Pro (Verity Medical, UK) surface electromyography (sEMG) device with testing and biofeedback features was used to measure the activity of the pelvic floor muscles, adductor and muscles'}], 'secondaryOutcomes': [{'measure': 'Female Sexual Function Index (FSFI)', 'timeFrame': '0-6 weeks', 'description': 'The FSFI consists of 19 questions and aims to determine the ongoing sexual functions of the person in the last four weeks.'}, {'measure': 'The Vaginal Penetration Cognition Questionnare (VPCQ)', 'timeFrame': '0-6 weeks', 'description': 'The questions in this questionnaire are aimed at investigating thoughts related to vaginal penetration.'}, {'measure': '"Does sexual intercourse occur?"', 'timeFrame': '0-6 weeks', 'description': 'Before and after the treatment, the participants were asked the question "Does sexual intercourse occur?" and their answers were collected as "Yes" and "No".'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual Dysfunction', 'Sexual Therapy', 'Electromyography', 'Pelvic Floor Physiotherapy', 'Vaginismus'], 'conditions': ['Women Health', 'Physiotherapy', 'Exercise']}, 'descriptionModule': {'briefSummary': 'Studies on pelvic floor physiotherapy in individuals diagnosed with vaginismus are quite limited in the literature. While current studies have focused on certain physiotherapy modalities, the literature is quite limited in terms of combined rehabilitation programs. There is a need for non-invasive therapy methods that can be an alternative for the patient and client population whose vaginismus problem continues after behavioral therapies. No studies on pelvic floor physiotherapy combined with sexual therapy have been found in the literature. In this context, our study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.', 'detailedDescription': 'Vaginismus is a sexual dysfunction defined as recurrent or persistent difficulty or impossibility of sexual intercourse due to involuntary contractions of the muscles in the vaginal area in women. This condition is usually associated with excessive tension and spasm of the pelvic floor muscles and adductor muscles when evaluated in terms of these muscle groups.\n\nSexuual therapy includes the placement of dilators of graduated sizes by the therapist at home or in a clinical setting, guided by both the patient and the partner, for systematic desensitization to vaginal penetration, and sexual education to alleviate the psychological impact of the condition. This method is most frequently used in studies and the reported success rates are quite high.\n\nVarious techniques such as breathing and relaxation exercises, local tissue desensitization, vaginal dilators, biofeedback and manual therapy are used within the scope of pelvic floor physiotherapy in the treatment of vaginismus. There are studies in the literature investigating the effectiveness of biofeedback exercises in the treatment of vaginismus with a 100% success rate. It has also been reported that the combined application of pelvic floor exercises with behavioral sexual therapy provides significant improvement. In this study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with vaginismus,\n* Being between the ages of 20-45,\n* Having an active sexual partner in the last 6 months,\n* Not being in the accompanying physiotherapy or psychotherapy process.\n\nExclusion Criteria:\n\n* Diagnosed with or treated for vulvodynia and/or vulvar vestibulitis,\n* Having a pacemaker,\n* Not being able to give personal consent,\n* Having a physical problem that would prevent treatment.'}, 'identificationModule': {'nctId': 'NCT06760767', 'briefTitle': 'Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Investigation of The Effectiveness of Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment', 'orgStudyIdInfo': {'id': 'E-10840098-202.3.02-222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Participants in the intervention group received pelvic floor physiotherapy combined with sexual therapy twice a week for 6 weeks.', 'interventionNames': ['Behavioral: sexual therapy', 'Behavioral: Pelvic floor physiotherapy combined with sexual therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Participants in the control group received sexual therapy twice a week for 6 weeks.', 'interventionNames': ['Behavioral: sexual therapy']}], 'interventions': [{'name': 'sexual therapy', 'type': 'BEHAVIORAL', 'description': 'In sexual therapy sessions, sexual education, cognitive restructuring, body awareness exercises, systematic desensitization, relaxation training, individual and partner home exercise training and dilator treatment were applied with the supervision of a physiotherapist. All techniques and stages were not applied in the same session and were used with a certain progression', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Pelvic floor physiotherapy combined with sexual therapy', 'type': 'BEHAVIORAL', 'description': 'Pelvic floor physiotherapy combined with sexual therapy was applied in the experimental group. Sexual therapy techniques were added appropriately before, during and after the pelvic floor physiotherapy session. In the pelvic floor physiotherapy sessions, pelvic floor muscle training, biofeedback, electrotherapy, manual therapy applications, breathing exercises, stretching and relaxation exercises were applied with the physiotherapist. Pelvic floor physiotherapy techniques and stages were applied in the same session and followed a certain progression.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34810', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Gülay Aras Bayram, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Gülay Aras', 'investigatorAffiliation': 'Medipol University'}}}}