Clinical trial NCT01171846: A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse
Official title: A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: prevention
pelvic floor muscle training
prolapse symptoms
urinary symptoms
sexual function
randomised controlled trial
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: University of Birmingham
name: Birmingham Women's NHS Foundation Trust
name: University of Aberdeen
name: Aberdeen Royal Infirmary
name: University of Otago
First posted: 2010-07-29
Enrollment: 337
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other organs moving down from their normal position in the pelvis and pushing into the vagina. This is a very common problem and many women who have given birth will have a very mild bulge which does not cause them symptoms. Women can however experience a variety of pelvic, bladder, bowel and sexual symptoms which impact on daily life. No research studies have properly examined whether or not exercises can prevent prolapse. This study aims to explore whether exercises taught by a physiotherapist can prevent women developing a prolapse which requires them to have treatment.


Eligibility criteria: Inclusion Criteria:

Women involved in the ProLong study who:

* have some evidence of vaginal laxity in any compartment (POP-Q stage I, II or III)
* have had no previous treatment for prolapse (surgery, pessary, PFMT)

Women must be willing to participate in the Trial and to comply with their group allocation.

Exclusion Criteria:

Women:

* with stage 0 or IV prolapse
* who have had previous incontinence surgery (except mid-urethral sling operation)
* who have had previous formal instruction in PFMT for any diagnosis in preceding five years
* who are pregnant, or delivered a baby within the last six months
* who are unable to comply with PFMT treatment
* who are unable to give informed consent

Primary outcomes:
measure: Pelvic organ prolapse symptom score (POP-SS)
timeFrame: Baseline (prior to randomisation)
measure: Pelvic organ prolapse symptom score (POP-SS)
timeFrame: 1 Year post randomisation
measure: Pelvic organ prolapse symptom score (POP-SS)
timeFrame: 2 years post randomisation
measure: Pelvic organ prolapse symptom score (POP-SS)
timeFrame: 3 years post randomisation
measure: Pelvic organ prolapse symptom score (POP-SS)
timeFrame: 4 years post randomisation
Secondary outcomes:
measure: Prolapse-related quality of life
timeFrame: Baseline (prior to randomisation)
measure: Prolapse severity
timeFrame: Four years post randomisation
measure: Lifestyle changes
timeFrame: 1 year post randomisation
measure: Urinary symptoms
timeFrame: Baseline (prior to randomisation)
measure: Bowel symptoms
timeFrame: Baseline (prior to randomisation)
measure: Sexual symptoms
timeFrame: Baseline (prior to randomisation)
measure: General health status
timeFrame: Baseline (prior to randomisation)
measure: Need for prolapse treatment
timeFrame: 1 year post randomisation
measure: The average number of days of prolapse symptoms
timeFrame: Baseline (prior to randomisation)
measure: Prolapse-related quality of life
timeFrame: 1 year post randomisation
measure: Prolapse-related quality of life
timeFrame: 2 years post randomisation
measure: Prolapse-related quality of life
timeFrame: 3 years post randomisation
measure: Prolapse-related quality of life
timeFrame: 4 years post of randomisation
measure: Lifestyle changes
timeFrame: 2 years post randomisation
measure: Lifestyle changes
timeFrame: 3 years post randomisation
measure: Lifestyle changes
timeFrame: 4 years post randomisation
measure: Urinary symptoms
timeFrame: 1 year post randomisation
measure: Urinary symptoms
timeFrame: 2 years post randomisation
measure: Urinary symptoms
timeFrame: 3 years post randomisation
measure: Urinary symptoms
timeFrame: 4 years post randomisation
measure: Bowel symptoms
timeFrame: 1 year post randomisation
measure: Bowel symptoms
timeFrame: 2 years post randomisation
measure: Bowel symptoms
timeFrame: 3 years post randomisation
measure: Bowel symptoms
timeFrame: 4 years post randomisation
measure: Sexual symptoms
timeFrame: 1 year post randomisation
measure: Sexual symptoms
timeFrame: 2 years post randomisation
measure: Sexual symptoms
timeFrame: 3 years post randomisation
measure: Sexual symptoms
timeFrame: 4 years post randomisation
measure: General health status
timeFrame: 1 year post randomisation
measure: General health status
timeFrame: 2 years post randomisation
measure: General health status
timeFrame: 3 years post randomisation
measure: General health status
timeFrame: 4 years post randomisation
measure: Need for prolapse treatment
timeFrame: 2 years post randomisation
measure: Need for prolapse treatment
timeFrame: 3 years post randomisation
measure: Need for prolapse treatment
timeFrame: 4 years post randomisation
measure: The average number of days of prolapse symptoms
timeFrame: 1 year post randomisation
measure: The average number of days of prolapse symptoms
timeFrame: 2 years post randomisation
measure: The average number of days of prolapse symptoms
timeFrame: 3 years post randomisation
measure: The average number of days of prolapse symptoms
timeFrame: 4 years post randomisation
Other outcomes:
Locations:
city: Dunedin
country: New Zealand
facility: Dunedin School of Medicine
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Aberdeenshire
city: Edgbaston
country: United Kingdom
facility: Birmingham Women's Hospital
state: Birmingham
Study officials:
affiliation: NMAHP Research Unit
name: Prof Hagen, PhD MSc BSc CStat CSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hagen, S., C. Glazener, D. McClurg, C. Macarthur, P. Herbison, D. Wilson, P. Toozs-Hobson et al.
citation: Hagen S, Glazener C, McClurg D, Macarthur C, Elders A, Herbison P, Wilson D, Toozs-Hobson P, Hemming C, Hay-Smith J, Collins M, Dickson S, Logan J. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial. Lancet. 2017 Jan 28;389(10067):393-402. doi: 10.1016/S0140-6736(16)32109-2. Epub 2016 Dec 21.