Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:23 PM
Study NCT ID:
NCT07446556
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-16
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Program in Women With Pudendal Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle stiffness by shear-wave elastography (SWE)', 'timeFrame': 'Baseline and 6 months (post-intervention)', 'description': 'Pelvic floor muscle stiffness (kPa) measured by shear-wave elastography in superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscles). Measurements were obtained using a 2 mm circular ROI with real-time quality control (RLB \\> 90%, M-STB 4-5 stars). Shell analysis was used to identify sites of minimum and maximum stiffness within each muscle.'}], 'secondaryOutcomes': [{'measure': 'Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)', 'timeFrame': 'Baseline and 6 months (post-intervention)', 'description': 'PFIQ-7 is a 21-item questionnaire assessing the impact of pelvic floor disorders across urinary, colorectal-anal, and prolapse/vaginal symptom domains. Total score ranges from 0 to 300; higher scores indicate greater negative impact on quality of life.'}, {'measure': 'Female Sexual Distress Scale-Revised (FSDS-R)', 'timeFrame': 'Baseline and 6 months (post-intervention)', 'description': 'FSDS-R is a 13-item questionnaire measuring sexually related personal distress. Each item is scored on a 5-point Likert scale (0-4). Total score ranges from 0 to 52; higher scores indicate greater sexual distress.'}, {'measure': 'Pain/discomfort intensity by visual analog scale (VAS)', 'timeFrame': 'Baseline and 6 months (post-intervention)', 'description': 'Pain and discomfort were assessed using VAS in five domains: bladder, vagina, perineum, rectum, and dyspareunia (pain during sexual intercourse).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pudendal neuralgia Chronic pelvic pain Pelvic floor physiotherapy Shear-wave elastography Pelvic floor muscle stiffness'], 'conditions': ['Pudendal Neuralgia- Physiotherapy']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial compares a 6-month physiotherapy exercise program versus no structured exercise intervention in women with pudendal neuralgia. Outcomes include pelvic floor muscle stiffness measured by shear-wave elastography (SWE), pelvic floor symptom burden (PFIQ-7), sexual distress (FSDS-R), and pain/discomfort scores (VAS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Yes (if PRS asks whether eligibility is based on sex/gender)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants aged 18 years or older\n* Confirmed diagnosis of pudendal neuralgia based on all five Nantes diagnostic criteria\n* Duration of symptoms at least 3 months\n* Written informed consent provided\n\nExclusion Criteria:\n\n* History of psychiatric, neurological (except pudendal neuralgia), severe internal medical, orthopedic, or oncological disease\n\n * Botulinum toxin therapy within the previous 12 months\n * Pelvic surgery within the previous 12 months\n * Incomplete or incorrectly completed questionnaires\n * Refusal to participate or withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT07446556', 'acronym': 'ELASTIN', 'briefTitle': 'Exercise Program in Women With Pudendal Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'Comenius University'}, 'officialTitle': 'Comparison of Shear-Wave Elastography of Superficial Pelvic Floor Muscles in Healthy Women and Women With Pudendal Neuralgia', 'orgStudyIdInfo': {'id': '6808/2023/ODDZ-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic Floor Relaxation Protocol', 'description': 'Participants received a 6-month physiotherapy intervention consisting of 6 individual sessions with a physiotherapist and daily home exercise (30 minutes/day).', 'interventionNames': ['Behavioral: Pelvic Floor Relaxation Protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants did not receive the structured physiotherapy exercise program.'}], 'interventions': [{'name': 'Pelvic Floor Relaxation Protocol', 'type': 'BEHAVIORAL', 'description': 'A structured 6-month physiotherapy program was implemented, focusing on pelvic floor muscle relaxation, postural correction, and functional movement patterns.The program included 6 individual sessions with a physiotherapist and mandatory daily home exercise (30 minutes/day). Adherence was recorded in participant diaries.', 'armGroupLabels': ['Pelvic Floor Relaxation Protocol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Martin', 'state': 'Slovakia', 'country': 'Slovakia', 'facility': 'Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}], 'overallOfficials': [{'name': 'Magdalena Hagovska, prof.PhDr.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia'}, {'name': 'Jan Svihra, prof.MUDr.PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comenius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}