Clinical trial NCT03511911: The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study
Official title: The Evaluation of Pelvic Floor Muscle Function: A Reliability and Correlation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Dysfunction
Keywords: Pelvic floor muscle strength
modified Oxford Grading Scale
Levator ani testing
vaginal contraction pressure
reliability
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum vaginal contraction pressure
timeFrame: 3 days
Secondary outcomes:
measure: vaginal rest pressure
timeFrame: 3 days
measure: Pelvic floor muscle strength
timeFrame: 1 day
measure: Pelvic floor muscle strength（repitition）
timeFrame: 1 day
measure: Pelvic floor muscle contraction endurance
timeFrame: 3 days
measure: pelvic organ prolapse quantification(POP-Q)
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
state: Beiing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
name: Lan Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: