Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT03516266
Status:
UNKNOWN
Last Update Posted:
2018-05-11
First Post:
2018-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7920}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2018-04-13', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum vaginal contraction pressure', 'timeFrame': '1 day', 'description': 'it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Pelvic floor muscle strength', 'timeFrame': '1 day', 'description': 'The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation. range(0-5).The higher values represent better outcomes.\n\nthrough vaginal palpation.'}, {'measure': 'Pelvic floor muscle strength（repetition）', 'timeFrame': '1 day', 'description': 'Levator ani testing is used to quantify PFM strength. range(0-5). The higher values represent better outcomes.'}, {'measure': 'Pelvic floor muscle contraction endurance', 'timeFrame': '1 day', 'description': 'muscle contractions maintained for 0 s are defined as grade 0, 1 s as grade I, 2 s as grade II, 3 s as grade III, 4 s as grade IV, and 5 s or longer as grade V. Normal muscles can maintain the contraction for 5 s. range(0-5s). The higher values represent better outcomes.'}, {'measure': 'pelvic organ prolapse quantification', 'timeFrame': '1 day', 'description': 'POP-Q is measured when maximum valsalva. range(0-4). stage 0 represents normal.'}, {'measure': 'the knack test', 'timeFrame': '1 day', 'description': 'a voluntary PFM contraction before or during coughing. That the contraction could be performed represents normal.'}, {'measure': 'vaginal rest pressure', 'timeFrame': '1 day', 'description': 'measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic floor muscle strength', 'Premenopausal nullipara', 'Childbirth', 'Postmenopausal'], 'conditions': ['Pelvic Floor']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the status of pelvic floor function of healthy female in China, including premenopausal nullipara, premenopausal women with childbirth and postmenopausal women.', 'detailedDescription': 'This is a cross-sectional survey. The normal physical examination population is divided into three groups,including premenopausal nullipara, premenopausal women with childbirth and postmenopausal women. The pelvic floor muscle function in three groups are evaluated. The modified Oxford Grading Scale and Levator ani testing is used to quantify PFM strength through vaginal palpation. Pelvic floor muscle strength ,endurance, repetition,vaginal contraction pressure and the knack test are evaluated using a PHENIX USB 8 neuromuscular stimulation therapy system (Company: Vivaltis-Electronic Concept Lignon Innovation, Montpellier, France). In six different regions of China according to geographic region (northwest, southwest, north, east, northeast, and central-south China) , 1 or more hospitals in each area are selected as sub-centers, which needs to complete the evaluation of pelvic floor muscle function of 360 cases in 3 groups totally.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteers are divided into three groups, and each clinical center requires at least 120 persons in each group.\n\nGroup A: Premenopausal women without history of abortion or delivery.\n\nGroup B: Premenopausal women with childbirth (including cesarean section or natural birth).\n\nGroup C:Postmenopausal women (except surgical menopause).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nGroup A：Premenopausal women without history of abortion or delivery\n\n1. Having sex life and tolerable to vaginal examination\n2. Premenopausal women without history of abortion over 16 weeks\n3. Premenopausal women without history of childbirth\n4. Planning to live locally for a long time\n\nGroup B：Premenopausal women with childbirth\n\n1. Having sex life and tolerable to vaginal examination\n2. Premenopausal women with childbirth (including cesarean section or natural birth).\n3. Planning to live locally for a long time\n\nGroup C:Postmenopausal women (over a year, except surgical menopause)\n\n1. Having sex life and tolerable to vaginal examination\n2. Postmenopausal women\n3. Planning to live locally for a long time\n\nExclusion Criteria:\n\n1. Incontinence 4 weeks before enrollment\n2. History of fecal incontinence\n3. Prolapse beyond the level of the hymen\n4. History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）\n5. History of pelvic radiotherapy\n6. History of pelvic floor surgery\n7. History of abortion over 16 weeks' pregnancy or in 1 year after delivery\n8. Duration of pregnancy\n9. Duration of lactation\n10. History of hysterectomy\n11. Latex allergy\n12. Colpitis"}, 'identificationModule': {'nctId': 'NCT03516266', 'briefTitle': 'A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female', 'orgStudyIdInfo': {'id': 'JS-1550'}}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beiing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhijing Sun, MD', 'role': 'CONTACT', 'email': 'sunzhj2001@sina.com', 'phone': '13651314354'}], 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhijing Sun, MD', 'role': 'CONTACT', 'email': 'sunzhj2001@sina.com', 'phone': '13651314354'}, {'name': 'Lan Zhu, MD', 'role': 'CONTACT', 'email': 'zhu_julie@vip.sina.com'}], 'overallOfficials': [{'name': 'Lan Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Liuzhou Maternity and Child Healthcare Hospital', 'class': 'OTHER'}, {'name': 'Qingdao Municipal Hospital', 'class': 'OTHER'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': 'Maternity and Child Health Hospital of Changsha', 'class': 'UNKNOWN'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Huaian Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'Hunan Provincial Maternal and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'The Fourth Hospital of Shijiazhuang', 'class': 'OTHER'}, {'name': 'Shenzhen Luohu District Maternity And Child Healthcare Hospital', 'class': 'UNKNOWN'}, {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': "Hubei Shiyan People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Changzhi Maternity & Child Health Hospital', 'class': 'OTHER'}, {'name': 'Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region', 'class': 'UNKNOWN'}, {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'Shen-Zhen City Maternity and Child Healthcare Hospital', 'class': 'OTHER'}, {'name': 'Dalian Medical University', 'class': 'OTHER'}, {'name': 'Maternity and Child Care Center of QinHuangDao City', 'class': 'UNKNOWN'}, {'name': "The People's Hospital of Leshan", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}