Mitigating Chronic Pelvic Floor Dysfunction Following Childbirth by Pelvic Floor Dynamometry

NCT02391285 | Completed DMC

• 1 other identifier: STH18128 V1.0, 05 April 2014
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the potential clinical utility of measuring pelvic floor muscle tone after childbirth by vaginal dynamometry, the investigators will study 50 consecutive consenting first attendees of the Jessop Wing perineal trauma clinic. In addition to clinical and imaging assessment routinely offered women at this clinic, the investigators will measure their active and passive pelvic floor muscle tone using the Auckland vaginal elastometer. The investigators will also assess structural pelvic floor muscle damage (PFMD) in a subset of 10 women (5 symptomatic and 5 asymptomatic) by Magnetic Resonance Imaging (MR) scan of the pelvic hiatus. The investigators will then determine the predictive capacity of vaginal elastometry for symptoms of pelvic floor damage, findings of endoanal sonography, and MR scans of the pelvic floor hiatus. The investigators will determine if vaginal elastometry can prove an objective and accurate frontline assessment tool for the management of PFMD following childbirth. Our observations will generate vital data for powering and designing a large clinical trial evaluating the potential use of the vaginal elastometer as a first line assessment tool of PFMD in the postnatal period. Data will also inform the design of a personalised model for predicting and managing pelvic floor muscle damage during childbirth.

Conditions

Pelvic Floor Dysfunction

Outcome Measures

Primary Outcomes (3)

• Pelvic Floor Stiffness Measurement (Newtons) and correlation with muscular defects on pelvic MRI and endo-anal sonography (composite measure)

  measure pelvic floor muscle stiffness (Newtons) and validate pelvic floor muscle assessment by VD against image--based detection of anatomical deficits and damage to the levator ani and perineal muscles.

  6 months

• Pelvic Floor Stiffness Measurements (Newtons) and correlation with subjective clinical assessment and symptom questionnaires (EPAQPF) (composite measure)

  measure pelvic floor muscle stiffness (Newtons) and validate pelvic floor muscle assessment by VD against subjective clinical assessment of pelvic floor tone and perineal defects, and findings from symptom assessment questionnaires and acceptability questionnaires from service users

  6 months

• generation of test-retest reliability data presented as a force (N) and displacement (mm) time chart and as a force---displacement X--Y plot.

  6 months

Study Arms (1)

pelvic floor dynamometry

EXPERIMENTAL

Device: dynamometer (Auckland vaginal elastometer)

Interventions

dynamometer (Auckland vaginal elastometer) DEVICE

The elastometer is a modified vaginal speculum which captures pelvic muscle tone over 3 minutes and records this on an attached computer. In addition to the elastometer test, there are three further related tests, which patients would be suitable to participate in. I. a questionnaire to fill in so as to obtain some feedback from patients regarding what they thought of the test and the device. II. The investigators would like to repeat the elastometer measurement within a week of the first test to determine the reliability and accuracy of repeating the measurement after a few days. III. The investigator would like to request that the patient have an MRI scan of the pelvic muscles to check whether the elastometer can pick up functional muscle weakness that would not otherwise be recognised except by performing an MRI scan. The investigators will therefore compare elastometer readings to the MRI scan findings.

Also known as: elastometer

pelvic floor dynamometry

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

All women referred to the PTC of the JW will be eligible for inclusion in the study if they agree. Women who have had previous perineal surgery or surgery for genital prolapse or stress UI will be excluded from the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Jessop Wing

Sheffield, S10 2SF, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: March 18, 2015
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)