A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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.

Official Title
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A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Other: Pelvic Floor Muscle training


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physiotherapy<br> | Other: Pelvic Floor Muscle training<br>* 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.<br>|
| No Intervention: Control<br>Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic organ prolapse symptom score (POP-SS) | A summation of responses to seven prolapse symptom questions (range 0-28) | Baseline (prior to randomisation) | 
| Pelvic organ prolapse symptom score (POP-SS) | A summation of responses to seven prolapse symptom questions (range 0-28) | 1 Year post randomisation | 
| Pelvic organ prolapse symptom score (POP-SS) | A summation of responses to seven prolapse symptom questions (range 0-28) | 2 years post randomisation | 
| Pelvic organ prolapse symptom score (POP-SS) | A summation of responses to seven prolapse symptom questions (range 0-28) | 3 years post randomisation | 
| Pelvic organ prolapse symptom score (POP-SS) | A summation of responses to seven prolapse symptom questions (range 0-28) | 4 years post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolapse-related quality of life | Single item scored 0 to 10 | Baseline (prior to randomisation) | 
| Prolapse severity | Pelvic Organ Prolapse Quantification assessment | Four years post randomisation | 
| Lifestyle changes |  | 1 year post randomisation | 
| Urinary symptoms | ICIQ urinary incontinence short-form | Baseline (prior to randomisation) | 
| Bowel symptoms | ICIQ bowel symptoms module | Baseline (prior to randomisation) | 
| Sexual symptoms | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | Baseline (prior to randomisation) | 
| General health status | SF-12 | Baseline (prior to randomisation) | 
| Need for prolapse treatment |  | 1 year post randomisation | 
| The average number of days of prolapse symptoms |  | Baseline (prior to randomisation) | 
| Prolapse-related quality of life | Single item scored 0 to 10 | 1 year post randomisation | 
| Prolapse-related quality of life | Single item scored 0 to 10 | 2 years post randomisation | 
| Prolapse-related quality of life | Single item scored 0 to 10 | 3 years post randomisation | 
| Prolapse-related quality of life | Single item scored 0 to 10 | 4 years post of randomisation | 
| Lifestyle changes |  | 2 years post randomisation | 
| Lifestyle changes |  | 3 years post randomisation | 
| Lifestyle changes |  | 4 years post randomisation | 
| Urinary symptoms | ICIQ urinary incontinence short-form | 1 year post randomisation | 
| Urinary symptoms | ICIQ urinary incontinence short-form | 2 years post randomisation | 
| Urinary symptoms | ICIQ urinary incontinence short-form | 3 years post randomisation | 
| Urinary symptoms | ICIQ urinary incontinence short-form | 4 years post randomisation | 
| Bowel symptoms | ICIQ bowel symptoms module | 1 year post randomisation | 
| Bowel symptoms | ICIQ bowel symptoms module | 2 years post randomisation | 
| Bowel symptoms | ICIQ bowel symptoms module | 3 years post randomisation | 
| Bowel symptoms | ICIQ bowel symptoms module | 4 years post randomisation | 
| Sexual symptoms | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 1 year post randomisation | 
| Sexual symptoms | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 2 years post randomisation | 
| Sexual symptoms | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 3 years post randomisation | 
| Sexual symptoms | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 4 years post randomisation | 
| General health status | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 1 year post randomisation | 
| General health status | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 2 years post randomisation | 
| General health status | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 3 years post randomisation | 
| General health status | Prolapse Incontinence Sexual Questionnaire - PISQ 12 | 4 years post randomisation | 
| Need for prolapse treatment |  | 2 years post randomisation | 
| Need for prolapse treatment |  | 3 years post randomisation | 
| Need for prolapse treatment |  | 4 years post randomisation | 
| The average number of days of prolapse symptoms |  | 1 year post randomisation | 
| The average number of days of prolapse symptoms |  | 2 years post randomisation | 
| The average number of days of prolapse symptoms |  | 3 years post randomisation | 
| The average number of days of prolapse symptoms |  | 4 years post randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, pelvic floor muscle training, prolapse symptoms, urinary symptoms, sexual function, randomised controlled trial