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

Last updated: September 10, 2018
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fecal Incontinence

Genitourinary Prolapse

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT03511911
JS-1548
  • Ages 18-80
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

  3. healthy women for physical examination

  4. except in the first year after delivery,duration of lactation or with a cleardiagnosis as pelvic organ prolapse beyond the level of hymen or incontinence. Group B:patients with pelvic floor disorders

  5. patients diagnosed as incontinence by clinical presentation(patients with urinaryincontinence are required to complete the questionnaire of ICIQ-SF)

  6. patients with pelvic organ prolapse beyond the level of hymen

  7. except in the first year after delivery,duration of lactation and patients withchronic pelvic pain Group C: female who give birth to a child within a year(compliance and twice assessment areguaranteed,but PFMT are not allowed during the interval)

Exclusion

Exclusion Criteria:

  1. Patients who are undergoing pelvic floor muscle training

  2. History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladdercancer, 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

Total Participants: 450
Study Start date:
June 11, 2018
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

    Beijing, Beiing 100730
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.