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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
337
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.
Dunedin School of Medicine
Dunedin, New Zealand
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, United Kingdom
Birmingham Women's Hospital
Edgbaston, Birmingham, United Kingdom
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Time frame: Baseline (prior to randomisation)
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Time frame: 1 Year post randomisation
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Time frame: 2 years post randomisation
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Time frame: 3 years post randomisation
Pelvic organ prolapse symptom score (POP-SS)
A summation of responses to seven prolapse symptom questions (range 0-28)
Time frame: 4 years post randomisation
Prolapse-related quality of life
Single item scored 0 to 10
Time frame: Baseline (prior to randomisation)
Prolapse severity
Pelvic Organ Prolapse Quantification assessment
Time frame: Four years post randomisation
Lifestyle changes
Time frame: 1 year post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Time frame: Baseline (prior to randomisation)
Bowel symptoms
ICIQ bowel symptoms module
Time frame: Baseline (prior to randomisation)
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: Baseline (prior to randomisation)
General health status
SF-12
Time frame: Baseline (prior to randomisation)
Need for prolapse treatment
Time frame: 1 year post randomisation
The average number of days of prolapse symptoms
Time frame: Baseline (prior to randomisation)
Prolapse-related quality of life
Single item scored 0 to 10
Time frame: 1 year post randomisation
Prolapse-related quality of life
Single item scored 0 to 10
Time frame: 2 years post randomisation
Prolapse-related quality of life
Single item scored 0 to 10
Time frame: 3 years post randomisation
Prolapse-related quality of life
Single item scored 0 to 10
Time frame: 4 years post of randomisation
Lifestyle changes
Time frame: 2 years post randomisation
Lifestyle changes
Time frame: 3 years post randomisation
Lifestyle changes
Time frame: 4 years post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Time frame: 1 year post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Time frame: 2 years post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Time frame: 3 years post randomisation
Urinary symptoms
ICIQ urinary incontinence short-form
Time frame: 4 years post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Time frame: 1 year post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Time frame: 2 years post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Time frame: 3 years post randomisation
Bowel symptoms
ICIQ bowel symptoms module
Time frame: 4 years post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 1 year post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 2 years post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 3 years post randomisation
Sexual symptoms
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 4 years post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 1 year post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 2 years post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 3 years post randomisation
General health status
Prolapse Incontinence Sexual Questionnaire - PISQ 12
Time frame: 4 years post randomisation
Need for prolapse treatment
Time frame: 2 years post randomisation
Need for prolapse treatment
Time frame: 3 years post randomisation
Need for prolapse treatment
Time frame: 4 years post randomisation
The average number of days of prolapse symptoms
Time frame: 1 year post randomisation
The average number of days of prolapse symptoms
Time frame: 2 years post randomisation
The average number of days of prolapse symptoms
Time frame: 3 years post randomisation
The average number of days of prolapse symptoms
Time frame: 4 years post randomisation
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