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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01171846
Registration number
NCT01171846
Ethics application status
Date submitted
6/07/2010
Date registered
29/07/2010
Date last updated
17/03/2015
Titles & IDs
Public title
A Study of the Effects of Physiotherapy to Prevent Pelvic Organ Prolapse
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Scientific title
A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
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Secondary ID [1]
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PREVPROL Study RG1271
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Universal Trial Number (UTN)
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Trial acronym
PREVPROL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Renal and Urogenital
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Other renal and urogenital disorders
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pelvic Floor Muscle training
Active Comparator: Physiotherapy -
No Intervention: Control - Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group.
Other interventions: Pelvic 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pelvic organ prolapse symptom score (POP-SS)
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Assessment method [1]
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A summation of responses to seven prolapse symptom questions (range 0-28)
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Timepoint [1]
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Baseline (prior to randomisation)
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Primary outcome [2]
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Pelvic organ prolapse symptom score (POP-SS)
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Assessment method [2]
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A summation of responses to seven prolapse symptom questions (range 0-28)
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Timepoint [2]
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1 Year post randomisation
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Primary outcome [3]
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Pelvic organ prolapse symptom score (POP-SS)
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Assessment method [3]
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A summation of responses to seven prolapse symptom questions (range 0-28)
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Timepoint [3]
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2 years post randomisation
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Primary outcome [4]
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Pelvic organ prolapse symptom score (POP-SS)
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Assessment method [4]
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A summation of responses to seven prolapse symptom questions (range 0-28)
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Timepoint [4]
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3 years post randomisation
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Primary outcome [5]
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Pelvic organ prolapse symptom score (POP-SS)
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Assessment method [5]
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A summation of responses to seven prolapse symptom questions (range 0-28)
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Timepoint [5]
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4 years post randomisation
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Secondary outcome [1]
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Prolapse-related quality of life
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Assessment method [1]
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Single item scored 0 to 10
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Timepoint [1]
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Baseline (prior to randomisation)
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Secondary outcome [2]
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Prolapse severity
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Assessment method [2]
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Pelvic Organ Prolapse Quantification assessment
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Timepoint [2]
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Four years post randomisation
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Secondary outcome [3]
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Lifestyle changes
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Assessment method [3]
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Timepoint [3]
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1 year post randomisation
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Secondary outcome [4]
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Urinary symptoms
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Assessment method [4]
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ICIQ urinary incontinence short-form
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Timepoint [4]
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Baseline (prior to randomisation)
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Secondary outcome [5]
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Bowel symptoms
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Assessment method [5]
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ICIQ bowel symptoms module
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Timepoint [5]
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Baseline (prior to randomisation)
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Secondary outcome [6]
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Sexual symptoms
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Assessment method [6]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [6]
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Baseline (prior to randomisation)
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Secondary outcome [7]
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General health status
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Assessment method [7]
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SF-12
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Timepoint [7]
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Baseline (prior to randomisation)
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Secondary outcome [8]
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Need for prolapse treatment
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Assessment method [8]
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Timepoint [8]
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1 year post randomisation
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Secondary outcome [9]
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The average number of days of prolapse symptoms
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Assessment method [9]
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Timepoint [9]
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Baseline (prior to randomisation)
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Secondary outcome [10]
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Prolapse-related quality of life
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Assessment method [10]
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Single item scored 0 to 10
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Timepoint [10]
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1 year post randomisation
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Secondary outcome [11]
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Prolapse-related quality of life
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Assessment method [11]
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Single item scored 0 to 10
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Timepoint [11]
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2 years post randomisation
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Secondary outcome [12]
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Prolapse-related quality of life
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Assessment method [12]
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Single item scored 0 to 10
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Timepoint [12]
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3 years post randomisation
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Secondary outcome [13]
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Prolapse-related quality of life
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Assessment method [13]
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Single item scored 0 to 10
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Timepoint [13]
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4 years post of randomisation
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Secondary outcome [14]
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Lifestyle changes
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Assessment method [14]
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Timepoint [14]
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2 years post randomisation
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Secondary outcome [15]
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Lifestyle changes
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Assessment method [15]
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Timepoint [15]
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3 years post randomisation
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Secondary outcome [16]
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Lifestyle changes
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Assessment method [16]
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0
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Timepoint [16]
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4 years post randomisation
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Secondary outcome [17]
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Urinary symptoms
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Assessment method [17]
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ICIQ urinary incontinence short-form
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Timepoint [17]
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1 year post randomisation
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Secondary outcome [18]
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Urinary symptoms
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Assessment method [18]
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ICIQ urinary incontinence short-form
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Timepoint [18]
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2 years post randomisation
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Secondary outcome [19]
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Urinary symptoms
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Assessment method [19]
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ICIQ urinary incontinence short-form
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Timepoint [19]
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3 years post randomisation
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Secondary outcome [20]
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Urinary symptoms
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Assessment method [20]
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ICIQ urinary incontinence short-form
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Timepoint [20]
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4 years post randomisation
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Secondary outcome [21]
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Bowel symptoms
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Assessment method [21]
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ICIQ bowel symptoms module
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Timepoint [21]
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1 year post randomisation
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Secondary outcome [22]
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Bowel symptoms
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Assessment method [22]
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ICIQ bowel symptoms module
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Timepoint [22]
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2 years post randomisation
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Secondary outcome [23]
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Bowel symptoms
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Assessment method [23]
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ICIQ bowel symptoms module
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Timepoint [23]
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3 years post randomisation
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Secondary outcome [24]
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Bowel symptoms
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Assessment method [24]
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ICIQ bowel symptoms module
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Timepoint [24]
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4 years post randomisation
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Secondary outcome [25]
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Sexual symptoms
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Assessment method [25]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [25]
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1 year post randomisation
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Secondary outcome [26]
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Sexual symptoms
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Assessment method [26]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [26]
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2 years post randomisation
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Secondary outcome [27]
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Sexual symptoms
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Assessment method [27]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [27]
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3 years post randomisation
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Secondary outcome [28]
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Sexual symptoms
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Assessment method [28]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [28]
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4 years post randomisation
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Secondary outcome [29]
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General health status
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Assessment method [29]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [29]
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1 year post randomisation
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Secondary outcome [30]
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General health status
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Assessment method [30]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [30]
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2 years post randomisation
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Secondary outcome [31]
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General health status
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Assessment method [31]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [31]
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3 years post randomisation
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Secondary outcome [32]
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General health status
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Assessment method [32]
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Prolapse Incontinence Sexual Questionnaire - PISQ 12
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Timepoint [32]
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4 years post randomisation
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Secondary outcome [33]
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Need for prolapse treatment
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Assessment method [33]
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Timepoint [33]
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2 years post randomisation
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Secondary outcome [34]
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Need for prolapse treatment
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Assessment method [34]
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Timepoint [34]
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3 years post randomisation
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Secondary outcome [35]
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Need for prolapse treatment
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Assessment method [35]
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Timepoint [35]
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4 years post randomisation
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Secondary outcome [36]
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The average number of days of prolapse symptoms
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Assessment method [36]
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Timepoint [36]
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1 year post randomisation
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Secondary outcome [37]
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The average number of days of prolapse symptoms
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Assessment method [37]
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Timepoint [37]
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2 years post randomisation
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Secondary outcome [38]
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The average number of days of prolapse symptoms
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Assessment method [38]
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Timepoint [38]
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3 years post randomisation
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Secondary outcome [39]
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The average number of days of prolapse symptoms
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Assessment method [39]
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Timepoint [39]
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4 years post randomisation
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Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
337
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Dunedin
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Country [2]
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United Kingdom
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State/province [2]
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Aberdeenshire
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Country [3]
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United Kingdom
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State/province [3]
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Birmingham
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Funding & Sponsors
Primary sponsor type
Other
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Name
Glasgow Caledonian University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Birmingham
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Birmingham Women's NHS Foundation Trust
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Aberdeen
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Aberdeen Royal Infirmary
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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University of Otago
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01171846
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Hagen, PhD MSc BSc CStat CSci
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Address
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NMAHP Research Unit
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01171846
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