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

NCT ID: NCT03511911

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2020-12-31

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.

Conditions

Pelvic Floor Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

GROUP A1

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.

Group Type: EXPERIMENTAL

evaluation of pelvic floor muscle function through the PHENIX instrument

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

GROUP A2

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.

Group Type: EXPERIMENTAL

evaluation of pelvic floor muscle function through the PHENIX instrument

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

GROUP B1

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.

Group Type: EXPERIMENTAL

evaluation of pelvic floor muscle function through the PHENIX instrument

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

GROUP B2

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.

Group Type: EXPERIMENTAL

evaluation of pelvic floor muscle function through the PHENIX instrument

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

GROUP C1

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.

Group Type: EXPERIMENTAL

evaluation of pelvic floor muscle function through the PHENIX instrument

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

GROUP C2

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.

Group Type: EXPERIMENTAL

evaluation of pelvic floor muscle function through the PHENIX instrument

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

vaginal palpation

vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lan Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Locations

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beiing, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhijing Sun, MD

Role: CONTACT

sunzhj2001@sina.com

13651314354

Lan Zhu, MD

Role: CONTACT

zhu_julie@vip.sina.com

13911714696

Facility Contacts

Zhijing Sun, MD

Role: primary

sunzhj2001@sina.com

13651314354

Other Identifiers

JS-1548

Identifier Type: -

Identifier Source: org_study_id