Pelvic Organ Prolapse
Conditions
Keywords
prevention, pelvic floor muscle training, prolapse symptoms, urinary symptoms, sexual function, randomised controlled trial
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.
Interventions
OTHERPelvic Floor Muscle training
Women allocated to the intervention group will have five appointments with a specialist women's health physiotherapist (intervention physiotherapist) over 16 weeks who will prescribe a daily exercise programme and provide a Lifestyle Advice Sheet (focusing on weight loss, constipation, avoidance of heavy lifting, coughing and high-impact exercise) and relevant tailored advice (phase 1). Thereafter women in the intervention group will be offered Pilates-based classes, including PFMT, as maintenance (phase 2). Classes will be led by a physiotherapist who has undertaken Pilates training and will take place in six week blocks; each woman will be offered two six week blocks over a year. An exercise DVD will be provided for home use. Each woman will be offered a one-to-one review physiotherapy appointment at one and two years after randomisation.
Sponsors
University of Birmingham
Birmingham Women's NHS Foundation Trust
University of Aberdeen
Aberdeen Royal Infirmary
University of Otago
Glasgow Caledonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic organ prolapse symptom score (POP-SS) | Baseline (prior to randomisation) | A summation of responses to seven prolapse symptom questions (range 0-28) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolapse severity | Four years post randomisation | Pelvic Organ Prolapse Quantification assessment |
| Lifestyle changes | 1 year post randomisation | — |
| Urinary symptoms | Baseline (prior to randomisation) | ICIQ urinary incontinence short-form |
| Bowel symptoms | Baseline (prior to randomisation) | ICIQ bowel symptoms module |
| Prolapse-related quality of life | Baseline (prior to randomisation) | Single item scored 0 to 10 |
| General health status | Baseline (prior to randomisation) | SF-12 |
| Need for prolapse treatment | 1 year post randomisation | — |
| The average number of days of prolapse symptoms | Baseline (prior to randomisation) | — |
| Sexual symptoms | Baseline (prior to randomisation) | Prolapse Incontinence Sexual Questionnaire - PISQ 12 |
Countries
New Zealand, United Kingdom
Outcome results
None listed