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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?

Primary Purpose

Pelvic Organ Prolapse, Uterine Prolapse, Anterior Wall; Prolapse, Vaginal

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pelvic Floor Muscle training
Sponsored by
University of Salford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic floor muscle training, pelvic physiotherapy, pelvic floor exercises

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Gynaecologist diagnosed women with a mild / moderate or severe pelvic organ prolapse
  • >18 years old

Exclusion Criteria:

  • Unwilling or unable to provide informed consent (opt out of treatment)
  • Unable to contract the pelvic floor muscles (determined by the treating physiotherapist)
  • History of Pelvic cancer / or radiotherapy treatment within three months,
  • Neurological or psychiatric disorders,
  • Untreated urinary tract infections,
  • Pregnant or planning to become pregnant or given birth within the past year,
  • Recent vaginal surgery within twelve weeks or evidence of genital oedema,
  • Suspected infection or fragility of the genital area As indicated by the referral source or patient reported at the initial assessment.

Sites / Locations

  • National Health ServiceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pelvic Floor Muscle Training

Arm Description

Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist. Participants will be assessed at weeks 0 / 4 / 10 & 16 and the outcome measures will be recorded at week 0 & week 16. During each assessment, participants will be educated regarding the anatomy of pelvic organ prolapses and the pelvic floor muscles. They will be taught how to contract their pelvic floor, offered a vaginal examination, given a personalised pelvic floor muscle training programme (including the Knack) - up to a ten second hold long contractions (x 10 repitations) and up to 10 quick contractions. They will also be taught a sub max contraction for up to 30 seconds, offered lifestyle management advice including avoiding heavy lifting or straining. A leaflet explaining the aforementioned information will also be provided at the initial assessment.

Outcomes

Primary Outcome Measures

Pelvic Organ Prolapse Symptom Score (POPSS)
The POPSS is a patient-reported Outcome Measure consisting of seven POP symptom specific items, each with a five-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). The minimum score is 0 which would indicate that the pelvic organ prolapse in a-symptomatic and the maximum score for the POPSS is 28 which would indicate higher severity in pelvic organ prolapse symptoms. In addition, the women select a specific symptom which is most bothersome for them.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
July 5, 2019
Sponsor
University of Salford
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1. Study Identification

Unique Protocol Identification Number
NCT04009694
Brief Title
Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?
Official Title
Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Uterine Prolapse, Anterior Wall; Prolapse, Vaginal, Posterior Wall; Prolapse, Vaginal, Cystocele, Rectocele, Vault Prolapse, Vaginal
Keywords
Pelvic floor muscle training, pelvic physiotherapy, pelvic floor exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Floor Muscle Training
Arm Type
Experimental
Arm Description
Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist. Participants will be assessed at weeks 0 / 4 / 10 & 16 and the outcome measures will be recorded at week 0 & week 16. During each assessment, participants will be educated regarding the anatomy of pelvic organ prolapses and the pelvic floor muscles. They will be taught how to contract their pelvic floor, offered a vaginal examination, given a personalised pelvic floor muscle training programme (including the Knack) - up to a ten second hold long contractions (x 10 repitations) and up to 10 quick contractions. They will also be taught a sub max contraction for up to 30 seconds, offered lifestyle management advice including avoiding heavy lifting or straining. A leaflet explaining the aforementioned information will also be provided at the initial assessment.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle training
Intervention Description
Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse Symptom Score (POPSS)
Description
The POPSS is a patient-reported Outcome Measure consisting of seven POP symptom specific items, each with a five-point Likert response set (0 = never, 1 = occasionally, 2 = sometimes, 3 = most of the time and 4 = all of the time). The minimum score is 0 which would indicate that the pelvic organ prolapse in a-symptomatic and the maximum score for the POPSS is 28 which would indicate higher severity in pelvic organ prolapse symptoms. In addition, the women select a specific symptom which is most bothersome for them.
Time Frame
sixteen weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pelvic organ prolapse is a condition exclusive to women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gynaecologist diagnosed women with a mild / moderate or severe pelvic organ prolapse >18 years old Exclusion Criteria: Unwilling or unable to provide informed consent (opt out of treatment) Unable to contract the pelvic floor muscles (determined by the treating physiotherapist) History of Pelvic cancer / or radiotherapy treatment within three months, Neurological or psychiatric disorders, Untreated urinary tract infections, Pregnant or planning to become pregnant or given birth within the past year, Recent vaginal surgery within twelve weeks or evidence of genital oedema, Suspected infection or fragility of the genital area As indicated by the referral source or patient reported at the initial assessment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca C Whittle, MSc
Phone
0161 7202423
Email
R.Hadfield1@edu.salford.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Nicky Spence, PhD
Email
N.Spence@salford.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicky Spence, PhD
Organizational Affiliation
University of Salford
Official's Role
Study Chair
Facility Information:
Facility Name
National Health Service
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca C Whittle, MSc
Phone
0161 720 2423
Email
R.Hadfield1@edu.salford.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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