The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study

Not Applicable

• Conditions: Pelvic Floor Dysfunction

• Registration Number: NCT03511911
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

1. To explore the correlations among measures of PFM strength between using vaginal palpation quantified by modified Oxford Grading Scale and Levator ani testing and manometry in PHENIX instrument;

2. To determine the intra- and inter-rater reliability of PFM strength measured using manometry in PHENIX instrument.

Detailed Description

This is a study using a randomized crossover blind method.All the volunteers are divided into 2 groups randomly. At the first time, a gynecological physician evaluates patient's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling patient her result, and record it on a unique paper other than in the Case Report Form.

At the same day, patient will be tested by inspector A or B randomly twice with the PHENIX instrument.A 5 minutes' interval is needed between two tests in order to reduce the possibility of fatigue of pelvic floor muscles. The outcome is secretive to the patient as well.

A second time evaluation is required in 3 days' later by a different inspector from the first time.(interrater and intrarater) All the data including strength of MOS and LAT, the outcomes by inspector A and B, cannot be collected together and told to the patient until she finished the whole process.

Pelvic floor muscle training is not permitted during the evaluations.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-30
• Study Start: 2018-06-11
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1. Having sex life and tolerable to vaginal examination
2. Planning to live locally for a long time

Volunteers are divided into three groups Group A: healthy women

1. healthy women for physical examination
2. except in the first year after delivery,duration of lactation or with a clear diagnosis as pelvic organ prolapse beyond the level of hymen or incontinence.

Group B:patients with pelvic floor disorders

1. patients diagnosed as incontinence by clinical presentation(patients with urinary incontinence are required to complete the questionnaire of ICIQ-SF)
2. patients with pelvic organ prolapse beyond the level of hymen
3. except in the first year after delivery,duration of lactation and patients with chronic pelvic pain

Group C: female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval)

Exclusion Criteria

1. Patients who are undergoing pelvic floor muscle training
2. History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
3. History of pelvic radiotherapy
4. History of pelvic floor surgery
5. Duration of pregnancy
6. Latex allergy
7. Colpitis
8. Operation on pelvis within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Maximum vaginal contraction pressure	3 days	Maximum vaginal contraction pressure is evaluated by manometry

Secondary Outcome Measures

Name	Time	Method
vaginal rest pressure	3 days	measure when no vaginal contraction by manometry
Pelvic floor muscle strength	1 day	The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation
Pelvic floor muscle contraction endurance	3 days	muscle contractions maintained for 0 s are defined as grade 0,and 5 s or longer as grade V. Normal muscles can maintain the contraction for 5 s. The endurance is measured by PHENIX instrument.
Pelvic floor muscle strength（repitition）	1 day	Levator ani testing is used to quantify PFM strength
pelvic organ prolapse quantification(POP-Q)	1 day	POP-Q is measured when maximum valsalva

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences; 🇨🇳 Beijing, Beiing, China