Pelvic Floor Dysfunction
Conditions
Keywords
Pelvic floor muscle strength, modified Oxford Grading Scale, Levator ani testing, vaginal contraction pressure, reliability
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.
Interventions
DIAGNOSTIC_TESTevaluation 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.
DIAGNOSTIC_TESTvaginal palpation
vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum vaginal contraction pressure | 3 days | Maximum vaginal contraction pressure is evaluated by manometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vaginal rest pressure | 3 days | measure when no vaginal contraction by manometry |
| Pelvic floor muscle strength | 1 day | The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation |
| Pelvic floor muscle strength（repitition） | 1 day | Levator ani testing is used to quantify PFM strength |
| Pelvic floor muscle contraction endurance | 3 days | 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. |
| pelvic organ prolapse quantification(POP-Q) | 1 day | POP-Q is measured when maximum valsalva |
Countries
China
Contacts
Primary ContactZhijing Sun, MD
Backup ContactLan Zhu, MD
Outcome results
None listed