Pelvic FloorNCT03516266
A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female
An observational study of Pelvic Floor, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor
- How many people
- 7,920 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2018to 31 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers are divided into three groups, and each clinical center requires at least 120 persons in each group. Group A: Premenopausal women without history of abortion or delivery. Group B: Premenopausal women with childbirth (including cesarean section or natural birth). Group C:Postmenopausal women (except surgical menopause).
Who may be able to join
- Group A：Premenopausal women without history of abortion or delivery
- Having sex life and tolerable to vaginal examination
- Premenopausal women without history of abortion over 16 weeks
- Premenopausal women without history of childbirth
- Planning to live locally for a long time
- Group B：Premenopausal women with childbirth
Show all 13Show fewer
- Having sex life and tolerable to vaginal examination
- Premenopausal women with childbirth (including cesarean section or natural birth).
- Planning to live locally for a long time
- Group C:Postmenopausal women (over a year, except surgical menopause)
- Having sex life and tolerable to vaginal examination
- Postmenopausal women
- Planning to live locally for a long time
Who cannot join
- Incontinence 4 weeks before enrollment
- History of fecal incontinence
- Prolapse beyond the level of the hymen
- History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
- History of pelvic radiotherapy
- History of pelvic floor surgery
Show all 12Show fewer
- History of abortion over 16 weeks' pregnancy or in 1 year after delivery
- Duration of pregnancy
- Duration of lactation
- History of hysterectomy
- Latex allergy
- Colpitis
Trial locations and contacts
1 site in 1 country.
Lan Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Beijing, Beiing, 100730
Zhijing Sun, MD, 13651314354, sunzhj2001@sina.com
About this study
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.
Read the detailed description
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.
- Conditions
- Pelvic Floor
- Keywords
- Pelvic floor muscle strength, Premenopausal nullipara, Childbirth, Postmenopausal
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum vaginal contraction pressure
it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.
Measured: 1 day
Secondary outcomes (6)
Pelvic floor muscle strength
The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation. range(0-5).The higher values represent better outcomes.
through vaginal palpation.
Measured: 1 day
Pelvic floor muscle strength（repetition）
Levator ani testing is used to quantify PFM strength. range(0-5). The higher values represent better outcomes.
Measured: 1 day
Pelvic floor muscle contraction endurance
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.
Measured: 1 day
pelvic organ prolapse quantification
POP-Q is measured when maximum valsalva. range(0-4). stage 0 represents normal.
Measured: 1 day
the knack test
a voluntary PFM contraction before or during coughing. That the contraction could be performed represents normal.
Measured: 1 day
vaginal rest pressure
measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start10 May 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FloorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7,920 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital, Qingdao Municipal Hospital, Zhongshan People's Hospital, Guangdong, China, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital of Soochow University, Maternity and Child Health Hospital of Changsha, Henan Provincial People's Hospital, Huaian Maternal and Child Health Care Hospital, Hunan Provincial Maternal and Child Health Care Hospital, The Fourth Hospital of Shijiazhuang, Shenzhen Luohu District Maternity And Child Healthcare Hospital, Second Affiliated Hospital of Wenzhou Medical University, Hubei Shiyan People's Hospital, Changzhi Maternity & Child Health Hospital, Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region, The First Hospital of Hebei Medical University, Shen-Zhen City Maternity and Child Healthcare Hospital, Dalian Medical University, Maternity and Child Care Center of QinHuangDao City, The People's Hospital of Leshan
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, MD, Principal investigator, Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516266
- Sponsor's protocol ID
- JS-1550
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Female Pelvic Floor Muscle Function in Chinese Healthy Female
- ClinicalTrials.gov ID
- NCT03516266
- Acronym / sponsor ID
- JS-1550
- Conditions
- Pelvic Floor
- Keywords
- Pelvic floor muscle strength, Premenopausal nullipara, Childbirth, Postmenopausal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,920 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Liuzhou Maternity and Child Healthcare Hospital, Qingdao Municipal Hospital, Zhongshan People's Hospital, Guangdong, China, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital of Soochow University, Maternity and Child Health Hospital of Changsha, Henan Provincial People's Hospital, Huaian Maternal and Child Health Care Hospital, Hunan Provincial Maternal and Child Health Care Hospital, The Fourth Hospital of Shijiazhuang, Shenzhen Luohu District Maternity And Child Healthcare Hospital, Second Affiliated Hospital of Wenzhou Medical University, Hubei Shiyan People's Hospital, Changzhi Maternity & Child Health Hospital, Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region, The First Hospital of Hebei Medical University, Shen-Zhen City Maternity and Child Healthcare Hospital, Dalian Medical University, Maternity and Child Care Center of QinHuangDao City, The People's Hospital of Leshan
- Study start
- 10 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers are divided into three groups, and each clinical center requires at least 120 persons in each group. Group A: Premenopausal women without history of abortion or delivery. Group B: Premenopausal women with childbirth (including cesarean section or natural birth). Group C:Postmenopausal women (except surgical menopause).
Key inclusion criteria (13 listed)
- Group A：Premenopausal women without history of abortion or delivery
- Having sex life and tolerable to vaginal examination
- Premenopausal women without history of abortion over 16 weeks
- Premenopausal women without history of childbirth
- Planning to live locally for a long time
Key exclusion criteria (12 listed)
- Incontinence 4 weeks before enrollment
- History of fecal incontinence
- Prolapse beyond the level of the hymen
- History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
- History of pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maximum vaginal contraction pressure
Time frame: 1 day
it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes.
6 secondary outcomes
Pelvic floor muscle strength
Time frame: 1 day
Pelvic floor muscle strength（repetition）
Time frame: 1 day
Pelvic floor muscle contraction endurance
Time frame: 1 day
pelvic organ prolapse quantification
Time frame: 1 day
the knack test
Time frame: 1 day
vaginal rest pressure
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
Related trials for Pelvic Floor
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruitingObservational study
Clinical, Functional, and Therapeutic Characterization of Women With Urinary Incontinence and Analysis of Factors Associated With Treatment Response
Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Zhu, MD contact
Lan Zhu, MD principal investigator
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhijing Sun, MD (13651314354, sunzhj2001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum vaginal contraction pressure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.