Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-02 @ 5:51 PM
Study NCT ID:
NCT01635894
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Community Intervention Study of Female Pelvic Floor Condition and Knowledge of Pelvic Floor Exercises
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-04', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximal vaginal squeeze pressure (perineometry).', 'timeFrame': 'monthly for 3 months'}], 'secondaryOutcomes': [{'measure': 'endurance of contraction (perineometry)and digital vaginal palpation (MOS).', 'timeFrame': 'monthly for 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['female pelvic floor condition', 'pelvic floor training', 'supervised pelvic floor training', 'practice nurse', 'nurse specialist'], 'conditions': ['Behavioural']}, 'referencesModule': {'references': [{'pmid': '33624122', 'type': 'DERIVED', 'citation': 'Waterfield A, Waterfield M, Campbell J, Freeman R. Can effective supervised pelvic floor muscle training be provided by primary care nurses? A randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2717-2725. doi: 10.1007/s00192-021-04692-3. Epub 2021 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'The aims of the study were to attempt to answer the following questions; what proportion of women know how to and are able to exercise their pelvic floor and for those who cannot can they be trained and motivated to do so. This was a nested design comprising a prospective cohort study together with a controlled trial intervention after baseline assessment in the cohort study for a defined at-risk group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAble to give consent Aged above 18 years modified Oxford score, MOS, ≤ 2\n\nExclusion Criteria:\n\nUnable to give consent\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01635894', 'briefTitle': 'A Community Intervention Study of Female Pelvic Floor Condition and Knowledge of Pelvic Floor Exercises', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Plymouth NHS Trust'}, 'officialTitle': 'A Community Intervention Study of Female Pelvic Floor Condition and Knowledge of Pelvic Floor Exercises', 'orgStudyIdInfo': {'id': '1706'}, 'secondaryIdInfos': [{'id': 'WellBeing of Women', 'type': 'OTHER_GRANT', 'domain': 'PG428/02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nurse specialist', 'description': 'Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months.', 'interventionNames': ['Behavioral: Training']}, {'type': 'EXPERIMENTAL', 'label': 'practice nurse', 'description': 'Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment and training and were followed-up for their final assessment at 3 months.', 'interventionNames': ['Behavioral: Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Women were screened for a "weak pelvic floor" (modified Oxford score, MOS, ≤ 2) before being invited into the trial. The women were seen monthly after their initial assessment (but no training given) and were followed-up for their final assessment at 3 months.'}], 'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL', 'otherNames': ['Pelvic Floor Muscle Training (PFMT)'], 'description': 'Women in both the practice nurse and specialist nurse groups were given supervised pelvic floor exercise training. After the initial training they were given a daily exercise regimen and seen at monthly intervals for three months. The practice nurses had attended a study day on supervising Pelvic Floor Muscle Training(PFMT)followed by practice sessions with patients overseen by the nurse specialist.', 'armGroupLabels': ['nurse specialist', 'practice nurse']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL6 8DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Plymouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}], 'overallOfficials': [{'name': 'Robert Freeman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Plymouth NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}