Clinical trial NCT04009694: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: University of Salford
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pelvic Organ Prolapse Symptom Score (POPSS)
timeFrame: sixteen weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: National Health Service
Study officials:
affiliation: University of Salford
name: Nicky Spence, PhD
role: STUDY_CHAIR
References: