Effect of PEFLOW on PFM Function Recovery of Postpartum Women

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Active Comparator: Routine education group

Experimental: Global training group

About this trial

This is an interventional treatment trial for Pelvic Floor Muscle Weakness focused on measuring postpartum, global training, rehabilitation, pelvic floor muscle

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Newly born women within 42 days to 3 months after delivery, after the end of puerperium, initial postpartum review and pelvic floor professional outpatient screening, found that pelvic floor muscle strength decreased (Oxford Oxford muscle strength ≤ grade 3);
Healthy before pregnancy without pregnancy complications;
Convenient transportation, familiar with the Internet;
Be in good condition and be able to complete the exercise program;
Complete clinical baseline data;
Agreed to conduct the study and signed the informed consent.

Exclusion Criteria:

Patients with stage Ⅲ and Ⅳ pelvic organ prolapse;
Severe urinary incontinence;
lochia, vaginal bleeding and pregnancy;
Serious medical diseases, such as cardiac dysfunction who wear pacemakers, neurological diseases, cognitive impairment and other pathological conditions;
Cannot complete the intervention program;

Sites / Locations

The Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine education group

Global training group

Arm Description

Routine education, including postpartum lifestyle, Kegel exercise and Knack method.

Global training was added on the basis of routine education.

Outcomes

Primary Outcome Measures

Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training

The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction. 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 contracion.

Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training

We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.

Change from Baseline pelvic floor muscle strength at 1 year postpartum

The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction. 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 contracion.

Change from Baseline pelvic floor electrophysiology at 1 year postpartum

We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.

Secondary Outcome Measures

The occurrence of SUI

SUI is defined by SUI symptoms or a positive result of the stress test. Before the stress test, participants are suggested to keep fully bladder. Positive result of the stress test is defined as involuntarily urinary leakage when asked to cough in the lithotomy position.

Change from Pelvic floor ultrasound indicators

LAM thickness, diameter of the levator hiatus and levator hiatus area

Change from Pelvic Organ Prolapse Quantitation

Pelvic Organ Prolapse Quantitation is measured by callipers

Change from Physical activity levels

We use International Physical Activity Questionnaire score to measure the overall physical activity level during postpartum period.

Change from pelvic sagittal rotation degree

The quantitative measurement of pelvic sagittal rotation degree on X-ray was analyzed which includes the pelvic tilt angle , the sacral slope angle, the difference of sacral slope and pelvic tilt, the ratio of the pelvic tilt angle to the sacral slope angle, the ratio of the pelvic tilt angle to the pelvic incidence angle and sacral-femoral distance.

Change from body composition

Body composition analysis is measured which mainly includes Body Mass Index（BMI）based on height and weight in kg/m^2.

Change from body strength

Hand grip strength and trunk endurance are measured to describe body strength. Hand grip strength was measured by JAMAR Plus+ grip gauge. The measurement accuracy is 0.1kg. The participants should not have visible hand defects. The grip gauge should be adjusted before measurement. When the paticipants holds the grip gauge, the second knuckle of the index finger should be at 90 degrees. At the same time, mark the best position of each hand on the grip meter. Before measurement, the participants should remove wrist jewelry to avoid injury. And the left and right hand are measured alternately for 3 times.

Change from 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.

Change from PFIQ-7 Questionnaire Score

The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ).To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3.The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.

Change from 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.

Change from the Pittsburgh Sleep Quality Index (PSQI) Score

The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The 18 items consist of 7 components, and each component is scored according to the grade of 0 ~ 3. The cumulative score of each component is the total score of PSQI, and the total score range is 0~2l. The higher the score, the worse the sleep quality. It takes 5 to 10 minutes for the participants to complete the question.

Full Information

NCT ID

NCT05218239

First Posted

December 1, 2021

Last Updated

July 6, 2022

Sponsor

Peking University People's Hospital

Collaborators

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT05218239

Brief Title

Effect of PEFLOW on PFM Function Recovery of Postpartum Women

Official Title

Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 2, 2021 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University People's Hospital

Collaborators

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to explore the correlation between women's pelvic floor function with their overall state of bodily functions, including body composition, physical activity levels, trunk muscle endurance, body posture, vaginal and gut microbes. The main intervention of this study is a set of global training which Includes the strength, endurance, flexibility, stability and flexibility training on the diaphragm, abdominal, lower back, as well as pelvic floor muscles, on the basis Kegel training. The primary destination of global training is to shorten the cycle of postpartum pelvic floor functional recovery, improve the effect of maternal training, and convenient in clinical promotion.

Detailed Description

Training for 2 times a week, for 12 weeks leading by a specific physiotherapist.The training intensity was evaluated by RPE self-induced fatigue scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Floor Muscle Weakness, Rehabilitation

Keywords

postpartum, global training, rehabilitation, pelvic floor muscle

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Routine education group

Arm Type

Active Comparator

Arm Description

Routine education, including postpartum lifestyle, Kegel exercise and Knack method.

Arm Title

Global training group

Arm Type

Experimental

Arm Description

Global training was added on the basis of routine education.

Intervention Type

Behavioral

Intervention Name(s)

Active Comparator: Routine education group

Intervention Description

Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.

Intervention Type

Behavioral

Intervention Name(s)

Experimental: Global training group

Intervention Description

Global training was added on the basis of control group. The 30min-training plan is divided into 9 sections, of which, groups 1 to 8, each group takes about 3 minutes, the ninth group is cool down section, including stretching for 5 minutes and foam axis stretching for 1 minute.

Primary Outcome Measure Information:

Title

Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training

Description

The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction. 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 contracion.

Time Frame

Baseline; After 12 week training or 6th month postpartum

Title

Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training

Description

We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.

Time Frame

Baseline; After 12 week training or 6th month postpartum

Title

Change from Baseline pelvic floor muscle strength at 1 year postpartum

Description

The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction. 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 contracion.

Time Frame

Baseline; 1 year postpartum

Title

Change from Baseline pelvic floor electrophysiology at 1 year postpartum

Description

We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.

Time Frame

Baseline; 1 year postpartum

Secondary Outcome Measure Information:

Title

The occurrence of SUI

Description

SUI is defined by SUI symptoms or a positive result of the stress test. Before the stress test, participants are suggested to keep fully bladder. Positive result of the stress test is defined as involuntarily urinary leakage when asked to cough in the lithotomy position.

Time Frame