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?
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.
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