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

Pelvic Floor Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511911
• Other study ID #: JS-1548
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Peking Union Medical College Hospital
• Contact: Zhijing Sun, MD
• Phone: 13651314354
• Email: sunzhj2001[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Dysfunction

Intervention

Diagnostic Test:
• evaluation of pelvic floor muscle function through the PHENIX instrument
the PHENIX instrument was designed and produced for sensing muscle activity with surface electrodes, pressure probes and external captors,so it could test biological signals of pelvic floor muscle in human body.
• vaginal palpation
vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Beijing	Beiing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum vaginal contraction pressure	Maximum vaginal contraction pressure is evaluated by manometry	3 days
Secondary	vaginal rest pressure	measure when no vaginal contraction by manometry	3 days
Secondary	Pelvic floor muscle strength	The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation	1 day
Secondary	Pelvic floor muscle strength(repitition)	Levator ani testing is used to quantify PFM strength	1 day
Secondary	Pelvic floor muscle contraction endurance	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.	3 days
Secondary	pelvic organ prolapse quantification(POP-Q)	POP-Q is measured when maximum valsalva	1 day