Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
Secondary ID [1] 0 0
PREVPROL Study RG1271
Universal Trial Number (UTN)
Trial acronym
PREVPROL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Organ Prolapse 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pelvic organ prolapse symptom score (POP-SS)
Timepoint [1] 0 0
Baseline (prior to randomisation)
Primary outcome [2] 0 0
Pelvic organ prolapse symptom score (POP-SS)
Timepoint [2] 0 0
1 Year post randomisation
Primary outcome [3] 0 0
Pelvic organ prolapse symptom score (POP-SS)
Timepoint [3] 0 0
2 years post randomisation
Primary outcome [4] 0 0
Pelvic organ prolapse symptom score (POP-SS)
Timepoint [4] 0 0
3 years post randomisation
Primary outcome [5] 0 0
Pelvic organ prolapse symptom score (POP-SS)
Timepoint [5] 0 0
4 years post randomisation
Secondary outcome [1] 0 0
Prolapse-related quality of life
Timepoint [1] 0 0
Baseline (prior to randomisation)
Secondary outcome [2] 0 0
Prolapse severity
Timepoint [2] 0 0
Four years post randomisation
Secondary outcome [3] 0 0
Lifestyle changes
Timepoint [3] 0 0
1 year post randomisation
Secondary outcome [4] 0 0
Urinary symptoms
Timepoint [4] 0 0
Baseline (prior to randomisation)
Secondary outcome [5] 0 0
Bowel symptoms
Timepoint [5] 0 0
Baseline (prior to randomisation)
Secondary outcome [6] 0 0
Sexual symptoms
Timepoint [6] 0 0
Baseline (prior to randomisation)
Secondary outcome [7] 0 0
General health status
Timepoint [7] 0 0
Baseline (prior to randomisation)
Secondary outcome [8] 0 0
Need for prolapse treatment
Timepoint [8] 0 0
1 year post randomisation
Secondary outcome [9] 0 0
The average number of days of prolapse symptoms
Timepoint [9] 0 0
Baseline (prior to randomisation)
Secondary outcome [10] 0 0
Prolapse-related quality of life
Timepoint [10] 0 0
1 year post randomisation
Secondary outcome [11] 0 0
Prolapse-related quality of life
Timepoint [11] 0 0
2 years post randomisation
Secondary outcome [12] 0 0
Prolapse-related quality of life
Timepoint [12] 0 0
3 years post randomisation
Secondary outcome [13] 0 0
Prolapse-related quality of life
Timepoint [13] 0 0
4 years post of randomisation
Secondary outcome [14] 0 0
Lifestyle changes
Timepoint [14] 0 0
2 years post randomisation
Secondary outcome [15] 0 0
Lifestyle changes
Timepoint [15] 0 0
3 years post randomisation
Secondary outcome [16] 0 0
Lifestyle changes
Timepoint [16] 0 0
4 years post randomisation
Secondary outcome [17] 0 0
Urinary symptoms
Timepoint [17] 0 0
1 year post randomisation
Secondary outcome [18] 0 0
Urinary symptoms
Timepoint [18] 0 0
2 years post randomisation
Secondary outcome [19] 0 0
Urinary symptoms
Timepoint [19] 0 0
3 years post randomisation
Secondary outcome [20] 0 0
Urinary symptoms
Timepoint [20] 0 0
4 years post randomisation
Secondary outcome [21] 0 0
Bowel symptoms
Timepoint [21] 0 0
1 year post randomisation
Secondary outcome [22] 0 0
Bowel symptoms
Timepoint [22] 0 0
2 years post randomisation
Secondary outcome [23] 0 0
Bowel symptoms
Timepoint [23] 0 0
3 years post randomisation
Secondary outcome [24] 0 0
Bowel symptoms
Timepoint [24] 0 0
4 years post randomisation
Secondary outcome [25] 0 0
Sexual symptoms
Timepoint [25] 0 0
1 year post randomisation
Secondary outcome [26] 0 0
Sexual symptoms
Timepoint [26] 0 0
2 years post randomisation
Secondary outcome [27] 0 0
Sexual symptoms
Timepoint [27] 0 0
3 years post randomisation
Secondary outcome [28] 0 0
Sexual symptoms
Timepoint [28] 0 0
4 years post randomisation
Secondary outcome [29] 0 0
General health status
Timepoint [29] 0 0
1 year post randomisation
Secondary outcome [30] 0 0
General health status
Timepoint [30] 0 0
2 years post randomisation
Secondary outcome [31] 0 0
General health status
Timepoint [31] 0 0
3 years post randomisation
Secondary outcome [32] 0 0
General health status
Timepoint [32] 0 0
4 years post randomisation
Secondary outcome [33] 0 0
Need for prolapse treatment
Timepoint [33] 0 0
2 years post randomisation
Secondary outcome [34] 0 0
Need for prolapse treatment
Timepoint [34] 0 0
3 years post randomisation
Secondary outcome [35] 0 0
Need for prolapse treatment
Timepoint [35] 0 0
4 years post randomisation
Secondary outcome [36] 0 0
The average number of days of prolapse symptoms
Timepoint [36] 0 0
1 year post randomisation
Secondary outcome [37] 0 0
The average number of days of prolapse symptoms
Timepoint [37] 0 0
2 years post randomisation
Secondary outcome [38] 0 0
The average number of days of prolapse symptoms
Timepoint [38] 0 0
3 years post randomisation
Secondary outcome [39] 0 0
The average number of days of prolapse symptoms
Timepoint [39] 0 0
4 years post randomisation

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.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
337
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Dunedin
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Aberdeenshire
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Other
Name
Glasgow Caledonian University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Birmingham
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Birmingham Women's NHS Foundation Trust
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Aberdeen
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Aberdeen Royal Infirmary
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Otago
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Hagen, PhD MSc BSc CStat CSci
Address 0 0
NMAHP Research Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Hagen, S., C. Glazener, D. McClurg, C. Macarthur, ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01171846