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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04009694
• Other study ID #: USalford1
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 10, 2019

Study information

• Verified date: July 2019
• Source: University of Salford
• Contact: Rebecca C Whittle, MSc
• Phone: 0161 7202423
• Email: R.Hadfield1[@]edu.salford.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 10, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Pelvic Floor Muscle training
Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist

Locations

Country	Name	City	State
United Kingdom	National Health Service	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Salford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	sixteen weeks