NCT03511911

Brief Summary

  1. 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. 2.To determine the intra- and inter-rater reliability of PFM strength measured using manometry in PHENIX instrument.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 12, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

April 13, 2018

Last Update Submit

September 10, 2018

Conditions

Pelvic Floor Dysfunction

Keywords

Pelvic floor muscle strengthmodified Oxford Grading ScaleLevator ani testingvaginal contraction pressurereliability

Outcome Measures

Primary Outcomes (1)

  • Maximum vaginal contraction pressure

    Maximum vaginal contraction pressure is evaluated by manometry

    3 days

Secondary Outcomes (5)

  • vaginal rest pressure

    3 days

  • Pelvic floor muscle strength

    1 day

  • Pelvic floor muscle strength（repitition）

    1 day

  • Pelvic floor muscle contraction endurance

    3 days

  • pelvic organ prolapse quantification(POP-Q)

    1 day

Study Arms (6)

GROUP A1

EXPERIMENTAL

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.

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrumentDiagnostic Test: vaginal palpation

GROUP A2

EXPERIMENTAL

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.

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrumentDiagnostic Test: vaginal palpation

GROUP B1

EXPERIMENTAL

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.

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrumentDiagnostic Test: vaginal palpation

GROUP B2

EXPERIMENTAL

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.

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrumentDiagnostic Test: vaginal palpation

GROUP C1

EXPERIMENTAL

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.

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrumentDiagnostic Test: vaginal palpation

GROUP C2

EXPERIMENTAL

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.

Diagnostic Test: evaluation of pelvic floor muscle function through the PHENIX instrumentDiagnostic Test: vaginal palpation

Interventions

evaluation of pelvic floor muscle function through the PHENIX instrumentDIAGNOSTIC_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.

GROUP A1GROUP A2GROUP B1GROUP B2GROUP C1GROUP C2
vaginal palpationDIAGNOSTIC_TEST

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

GROUP A1GROUP A2GROUP B1GROUP B2GROUP C1GROUP C2

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having sex life and tolerable to vaginal examination
  • Planning to live locally for a long time
  • Volunteers are divided into three groups Group A: healthy women
  • healthy women for physical examination
  • 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
  • patients diagnosed as incontinence by clinical presentation(patients with urinary incontinence are required to complete the questionnaire of ICIQ-SF)
  • patients with pelvic organ prolapse beyond the level of hymen
  • 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)

You may not qualify if:

  • Patients who are undergoing pelvic floor muscle training
  • History of radical operation of pelvic cavity(cervical cancer,rectal cancer,bladder cancer, ect）
  • History of pelvic radiotherapy
  • History of pelvic floor surgery
  • Duration of pregnancy
  • Latex allergy
  • Colpitis
  • Operation on pelvis within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, Beiing, 100730, China

RECRUITING

Study Officials

  • Lan Zhu, MD

    Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijing Sun, MD

CONTACT

13651314354sunzhj2001@sina.com

Lan Zhu, MD

CONTACT

13911714696zhu_julie@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 30, 2018

Study Start

June 11, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

September 12, 2018

Record last verified: 2018-04

Locations

CN(1)