Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT04009694
Status:
UNKNOWN
Last Update Posted:
2019-07-09
First Post:
2019-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D014596', 'term': 'Uterine Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D052858', 'term': 'Cystocele'}, {'id': 'D020047', 'term': 'Rectocele'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014591', 'term': 'Uterine 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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006547', 'term': 'Hernia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-05', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic Organ Prolapse Symptom Score (POPSS)', 'timeFrame': 'sixteen weeks', 'description': 'The POPSS is a patient-reported Outcome Measure consisting of seven POP symptom specific items, each with a five-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). The minimum score is 0 which would indicate that the pelvic organ prolapse in a-symptomatic and the maximum score for the POPSS is 28 which would indicate higher severity in pelvic organ prolapse symptoms. In addition, the women select a specific symptom which is most bothersome for them.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic floor muscle training', 'pelvic physiotherapy', 'pelvic floor exercises'], 'conditions': ['Pelvic Organ Prolapse', 'Uterine Prolapse', 'Anterior Wall; Prolapse, Vaginal', 'Posterior Wall; Prolapse, Vaginal', 'Cystocele', 'Rectocele', 'Vault Prolapse, Vaginal']}, 'descriptionModule': {'briefSummary': 'The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy.\n\nCandidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. The data collection occurred in January-June 2019 and ethical approval was granted by School Research Ethics, University of Salford.\n\nTreatment aims to ensure there is respect for their autonomy, treatment is fair (Justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence).\n\nParticipants are required to complete a consent form prior to their initial session. To ensure methodological quality, the STROBE guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention.\n\nThe trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. They are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent NICE guidelines.\n\nThe outcome measures used will be the Pelvic Organ Prolapse symptom score (POPSS) and this will be documented before and after the 16 week period.\n\nAlong side the POPSS, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pelvic organ prolapse is a condition exclusive to women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gynaecologist diagnosed women with a mild / moderate or severe pelvic organ prolapse\n* \\>18 years old\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent (opt out of treatment)\n* Unable to contract the pelvic floor muscles (determined by the treating physiotherapist)\n* History of Pelvic cancer / or radiotherapy treatment within three months,\n* Neurological or psychiatric disorders,\n* Untreated urinary tract infections,\n* Pregnant or planning to become pregnant or given birth within the past year,\n* Recent vaginal surgery within twelve weeks or evidence of genital oedema,\n* Suspected infection or fragility of the genital area As indicated by the referral source or patient reported at the initial assessment.'}, 'identificationModule': {'nctId': 'NCT04009694', 'briefTitle': 'Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?', 'organization': {'class': 'OTHER', 'fullName': 'University of Salford'}, 'officialTitle': 'Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?', 'orgStudyIdInfo': {'id': 'USalford1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic Floor Muscle Training', 'description': 'Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist.\n\nParticipants will be assessed at weeks 0 / 4 / 10 \\& 16 and the outcome measures will be recorded at week 0 \\& week 16.\n\nDuring each assessment, participants will be educated regarding the anatomy of pelvic organ prolapses and the pelvic floor muscles. They will be taught how to contract their pelvic floor, offered a vaginal examination, given a personalised pelvic floor muscle training programme (including the Knack) - up to a ten second hold long contractions (x 10 repitations) and up to 10 quick contractions. They will also be taught a sub max contraction for up to 30 seconds, offered lifestyle management advice including avoiding heavy lifting or straining. A leaflet explaining the aforementioned information will also be provided at the initial assessment.', 'interventionNames': ['Other: Pelvic Floor Muscle training']}], 'interventions': [{'name': 'Pelvic Floor Muscle training', 'type': 'OTHER', 'description': 'Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist', 'armGroupLabels': ['Pelvic Floor Muscle Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M8 5RB', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rebecca C Whittle, MSc', 'role': 'CONTACT', 'email': 'R.Hadfield1@edu.salford.ac.uk', 'phone': '0161 720 2423'}], 'facility': 'National Health Service', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Rebecca C Whittle, MSc', 'role': 'CONTACT', 'email': 'R.Hadfield1@edu.salford.ac.uk', 'phone': '0161 7202423'}, {'name': 'Nicky Spence, PhD', 'role': 'CONTACT', 'email': 'N.Spence@salford.ac.uk'}], 'overallOfficials': [{'name': 'Nicky Spence, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Salford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rebecca Whittle BSc Hons. Specialist Pelvic Health Physiotherapist', 'investigatorFullName': 'Rebecca Whittle', 'investigatorAffiliation': 'University of Salford'}}}}