Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT03064750
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2017-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic floor muscle strength assessed by palpation', 'timeFrame': '9 months', 'description': 'Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.'}, {'measure': 'Pelvic floor muscle strength assessed by ultrasound', 'timeFrame': '9 months', 'description': 'Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change'}, {'measure': 'Symptoms of pelvic floor disorders', 'timeFrame': '9 months', 'description': 'Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)'}], 'secondaryOutcomes': [{'measure': 'Pelvic floor muscle strength assessed by perineometry', 'timeFrame': '9 months', 'description': 'measuring the pressure with vaginal manometry in cm H2O during pelvic floor contraction'}, {'measure': 'Pelvic floor muscle strength assessed by electromyography', 'timeFrame': '9 months', 'description': 'Assessed by vaginal surface electrode during pelvic floor contraction, measured in mV'}, {'measure': 'Proportion of anatomical pelvic organ prolapse', 'timeFrame': '9 months', 'description': 'Assessment with the Pelvic Organ Prolapse Quantification (POP-Q) System'}, {'measure': 'Proportion of anatomical sphincter ani defect', 'timeFrame': '9 months', 'description': 'Anatomical sphincter ani defect assessed by transperineal ultrasound'}, {'measure': 'Proportion of levator ani muscle trauma', 'timeFrame': '9 months', 'description': 'Assessed by transperineal ultrasound on contraction and Valsalva'}, {'measure': 'Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction', 'timeFrame': '9 months', 'description': 'Movement of the pelvic organs during Valsalva and contraction'}, {'measure': 'Imaging of synthetic implants assessed by ultrasound', 'timeFrame': '9 months', 'description': 'Registration of implants after pelvic floor surgery and their relations to anatomical structures in mm.'}, {'measure': 'Symptoms of pelvic floor disorders', 'timeFrame': '9 months', 'description': 'Symptoms of pelvic floor disorders assessed by validated questionnaire (PFIQ-7)'}, {'measure': 'Symptoms of pelvic floor disorders', 'timeFrame': '9 months', 'description': 'Symptoms of pelvic floor disorders assessed by visual analogue scale (VAS 1-10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise Therapy', 'Pelvic Floor', 'Preoperative Care'], 'conditions': ['Pelvic Organ Prolapse', 'Pelvic Floor Disorders']}, 'referencesModule': {'references': [{'pmid': '31237722', 'type': 'BACKGROUND', 'citation': 'Nyhus MO, Oversand SH, Salvesen O, Salvesen KA, Mathew S, Volloyhaug I. Ultrasound assessment of pelvic floor muscle contraction: reliability and development of an ultrasound-based contraction scale. Ultrasound Obstet Gynecol. 2020 Jan;55(1):125-131. doi: 10.1002/uog.20382. Epub 2019 Dec 13.'}, {'pmid': '32144829', 'type': 'RESULT', 'citation': 'Nyhus MO, Mathew S, Salvesen O, Salvesen KA, Stafne S, Volloyhaug I. Effect of preoperative pelvic floor muscle training on pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery: randomized controlled trial. Ultrasound Obstet Gynecol. 2020 Jul;56(1):28-36. doi: 10.1002/uog.22007. Epub 2020 Jun 9.'}, {'pmid': '33580809', 'type': 'RESULT', 'citation': 'Mathew S, Nyhus MO, Salvesen O, Salvesen KA, Stafne SN, Volloyhaug I. The effect of preoperative pelvic floor muscle training on urinary and colorectal-anal distress in women undergoing pelvic organ prolapse surgery-a randomized controlled trial. Int Urogynecol J. 2021 Oct;32(10):2787-2794. doi: 10.1007/s00192-021-04684-3. Epub 2021 Feb 13.'}]}, 'descriptionModule': {'briefSummary': "The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery.\n\nThe aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* referred to surgery for urogenital prolapse\n* informed consent\n\nExclusion Criteria:\n\n* not able to communicate in Norwegian or English\n* not able or willing to sign informed consent'}, 'identificationModule': {'nctId': 'NCT03064750', 'acronym': 'CONTRAPOP', 'briefTitle': 'Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse', 'orgStudyIdInfo': {'id': '2015/1751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-surgery exercise', 'description': 'pelvic floor exercises individually and in groups', 'interventionNames': ['Behavioral: pelvic floor exercises']}, {'type': 'OTHER', 'label': 'Waiting list', 'description': 'wait as usual until surgery', 'interventionNames': ['Other: Waiting list']}], 'interventions': [{'name': 'pelvic floor exercises', 'type': 'BEHAVIORAL', 'description': 'In preparation for surgery, patients receive individual information by a physiotherapist on pelvic floor anatomy and correct pelvic floor contraction. Patients are told to do the following pelvic floor exercises 3 times a day: 8-12 maximal contractions, hold contractions during 10 seconds, and 3 fast contractions after each long contraction. In addition exercise in groups with skilled physical therapists once a week during 12 weeks.', 'armGroupLabels': ['Pre-surgery exercise']}, {'name': 'Waiting list', 'type': 'OTHER', 'description': 'patients wait as usual until surgery without special treatment.', 'armGroupLabels': ['Waiting list']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Kjell Å Salvesen, md prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St Olavs Hospital University Hospital Trondheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}