Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05318768
Other study ID # PKUPH7
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date April 30, 2022

Study information

Verified date February 2023
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, it is assumed that grip strength is associated with pelvic floor muscle strength. And the outcome of pelvic floor function can be predicted by referring to the status of pelvic floor muscle strength through the value of grip strength, which is labor-saving, time-saving and more convenient for evaluating pelvic floor muscle function. Moderate physical activity and increase the overall strength can activate the potential mechanism of pelvic floor muscle contraction at the same time may be a "core muscles" overall effect, that core muscles mainly includes transverse abdominal muscle, pelvic floor muscles and the muscles around the back, these muscles in the body movement to spontaneous collaboration contract pelvic floor muscles, enhancing pelvic floor muscle function, thus reducing the incidence of pelvic floor dysfunction.


Description:

This study is a cross-sectional observational study, planned to enroll 942 participants from Gynecology Outpatient Clinic. Uniformly trained physicians as investigators to collect indicators from questionnaires and physical examinations. Questionnaires may contain general information which include the patient's age, height, body weight before pregnancy and childbirth, weight gain during pregnancy, gestational age, pregnancy time, production time, high palace, delivery mode, neonatal birth weight, body length, blood sugar, blood fat, whether or not to use during pregnancy, childbirth, labor, perineal laceration, forceps midwifery, episiotomy and epidural data, pelvic floor cognition degree, physical activity levels, pelvic floor dysfunction score, pelvic floor functional impact score and sexual function score (including the prenatal and postnatal participants). Physical examinations will be performed without the results of the questionnaire, including stress tests, pelvic floor POP-Q staging, pelvic floor muscle strength by palpation, vaginal relaxation degree, grip strength value, rectus abdominis separation, waist circumference, waist-hip ratio, etc. Through univariate analysis of the general data of the patients, the related factors of female PFD were obtained, and the independent influencing factors of PFD were found by binary Logistic regression analysis (the dependent variable in this study was a dichotomous variable). The ROC curve was used to evaluate the predictive value of patients' overall strength level, physical activity level, body shape and other indicators on PFD outcome.


Recruitment information / eligibility

Status Completed
Enrollment 929
Est. completion date April 30, 2022
Est. primary completion date October 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Gynecological outpatient clinic patients - In good condition and able to actively cooperate - Agree to conduct the study. - Age range: 18 to 80 years old Exclusion Criteria: - Patients who has a history of pelvic surgery or has had pelvic floor functional diseases - Patients who do not have sex - Pregnancy - Patients who have serious medical diseases - Patients with cardiac dysfunction or wear pacemakers - Patients with neurological diseases and cognitive impairment who are difficult to cooperate with the study

Study Design


Locations

Country Name City State
China Peking University Peoples Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University People's Hospital Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pelvic floor muscle strength grading The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contraction. through study completion,an average of one day
Primary Overall body strength measured by hand grip strength Grip strength index is used to evaluate adult muscle strength in Chinese National Physical Fitness Standards. Grip strength is an important indicator to evaluate an individual's upper limb strength and can reflect the overall muscle strength level which was used to evaluate the overall strength of participants. through study completion,an average of one day
Primary Physical activity levels International Physical Activity Questionnaire score- short from is used to measure the overall physical activity level. Paticipants volunteered for the study and filled out questionnaires to rate their levels of physical activity over the past week which can represent the overall physical activity level. through study completion, an average of the past one week
Primary Pelvic Floor Distress Inventory#PFDI-20#Questionnaire Score The Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) is the short-form version of the Pelvic Floor Distress Inventory (PFDI).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions.The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100.The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300. through study completion, an average of the past 3 months
Primary FSFI-6 Questionnaire Score The 6-item Female Sexual Function Index (FSFI) is a short form of the original 19-item FSFI that measures sexual function in women.It comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Desire and satisfaction items are rated on a 5-point Likert scale, ranging from 1 to 5, and the other items are rated on a 6-point Likert scale, ranging from 0 to 5. Total scores range from 2 to 30, with lower scores indicating worse sexual functioning. through study completion, an average of the past four weeks
See also
  Status Clinical Trial Phase
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Completed NCT05690555 - Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation N/A
Not yet recruiting NCT06455150 - Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary
Not yet recruiting NCT03456310 - Transperineal US on Basis of MRI in Female Pelvic Floor Dysfunction N/A
Completed NCT01938092 - Vaginal Diazepam for the Treatment of Female Pelvic Pain Phase 2
Completed NCT00884871 - Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders N/A
Completed NCT06014021 - Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions N/A
Recruiting NCT05950633 - Postoperative Active Recovery N/A
Not yet recruiting NCT05530681 - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth N/A
Completed NCT06206993 - Effects of Kieser Resistance Training Plus Kieser Pelvic Floor Training vs. Kieser Resistance Training Plus Traditional Pelvic Floor Exercise on Urinary Incontinence in Prostate Cancer Patients After Radical Prostatectomy N/A
Recruiting NCT03683264 - Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial. N/A
Active, not recruiting NCT04172519 - Pelvic Floor Muscles Training After Radical Prostatectomy. N/A
Suspended NCT04544735 - Improving Women's Function After Pelvic Radiation N/A
Completed NCT03715777 - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain Phase 3
Completed NCT05127512 - Pelvic Floor Disorder Education in Prenatal Care N/A
Completed NCT02259712 - Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy N/A
Completed NCT03714984 - The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence N/A
Not yet recruiting NCT05399901 - M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM) N/A
Completed NCT06193395 - Translation and Validation of the ICIQ-B in Danish N/A
Completed NCT04955418 - Effects of Epi-no Device on Pelvic Floor Dysfunctions N/A