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Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?

NCT04009694 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-09

No results posted yet for this study

Summary

The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy.

Candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. The data collection occurred in January-June 2019 and ethical approval was granted by School Research Ethics, University of Salford.

Treatment aims to ensure there is respect for their autonomy, treatment is fair (Justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence).

Participants are required to complete a consent form prior to their initial session. To ensure methodological quality, the STROBE guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention.

The trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. They are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent NICE guidelines.

The outcome measures used will be the Pelvic Organ Prolapse symptom score (POPSS) and this will be documented before and after the 16 week period.

Along side the POPSS, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.

Conditions

  • Pelvic Organ Prolapse
  • Uterine Prolapse
  • Anterior Wall; Prolapse, Vaginal
  • Posterior Wall; Prolapse, Vaginal
  • Cystocele
  • Rectocele
  • Vault Prolapse, Vaginal

Interventions

OTHER

Pelvic Floor Muscle training

Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist

Sponsors & Collaborators

  • University of Salford

    lead OTHER

Principal Investigators

  • Nicky Spence, PhD · University of Salford

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-09-01
Completion
2019-09-10

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009694 on ClinicalTrials.gov