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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Pelvic Floor Dysfunction

Treatments: Diagnostic Test: vaginal palpation; Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT03511911

JS-1548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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450 participants in 6 patient groups

GROUP A1

Experimental group

Description:

In GROUP A1, participants are all healthy women.A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the participant her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,participants in group A1 will be tested by inspector B twice in the same way as what they have done the first day.

Treatment:

Diagnostic Test: vaginal palpation

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument

GROUP A2

Experimental group

Description:

In GROUP A2,participants are all healthy women.A gynecological physician evaluates participant's pelvic floor muscle strength by vaginal palpation without telling the participant her result, and records it on a unique paper other than in the Case Report Form as what GROUP A1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,participants in group A2 will be tested by inspector A twice in the same way as what they have done the first day.

Treatment:

Diagnostic Test: vaginal palpation

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument

GROUP B1

Experimental group

Description:

In GROUP B1,patients are all with pelvic floor disorders.A gynecological physician evaluates the patient's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the patient her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,patients in group B1 will be tested by inspector B twice in the same way as what they have done the first day.

Treatment:

Diagnostic Test: vaginal palpation

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument

GROUP B2

Experimental group

Description:

In GROUP B2,patients are all with pelvic floor disorders.A gynecological physician evaluates the patient's pelvic floor muscle strength by vaginal palpation without telling patient her result, and records it on a unique paper other than in the Case Report Form as what GROUP B1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,patients in group B2 will be tested by inspector A twice in the same way as what they have done the first day.

Treatment:

Diagnostic Test: vaginal palpation

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument

GROUP C1

Experimental group

Description:

In GROUP C1,participants are all female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval).A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) without telling the participant her result, and records it on a unique paper other than in the Case Report Form.Then inspector A will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.After three days,participants in group C1 will be tested by inspector B twice in the same way as what they have done the first day.

Treatment:

Diagnostic Test: vaginal palpation

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument

GROUP C2

Experimental group

Description:

In GROUP C2,participants are all female who give birth to a child within a year(compliance and twice assessment are guaranteed,but PFMT are not allowed during the interval).A gynecological physician evaluates the participant's pelvic floor muscle strength by vaginal palpation without telling patient her result, and records it on a unique paper other than in the Case Report Form as what GROUP C1 do.Then it is inspector B who will test them twice using the PHENIX instrument with a 5 minutes' interval at the same day.Three days later,participants in group C2 will be tested by inspector A twice in the same way as what they have done the first day.

Treatment:

Diagnostic Test: vaginal palpation

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrument