Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000113358
Ethics application status
Approved
Date submitted
2/02/2008
Date registered
28/02/2008
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pelvic Organ Prolapse Physiotherapy (POPPY)
Scientific title
The effect of a physiotherapy-supervised pelvic floor muscle training (PFMT) program on pelvic organ prolapse severity and pelvic floor muscle strength.
Secondary ID [1] 290879 0
Nil known
Universal Trial Number (UTN)
U1111-1191-0569
Trial acronym
POPPY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pelvic organ prolapse 2742 0
Condition category
Condition code
Renal and Urogenital 2868 2868 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pelvic Floor Muscle Training: 5 appointments with a physiotherapist over 16 weeks, supplemented by a daily program of 3 exercise sessions. Adjunctive therapies such as electrical stimulation and biofeedback may be used as required. In addition, lifestyle advice (weight loss, chronic cough, heavy lifting and general exercise) will be provided.
ADDITIONAL INFORMATION: The physiotherapy appointments involve subjective and objective assessment and an individualised treatment program. The physiotherapist will ask the patient questions about her pelvic floor symptoms (bladder, bowel, sexual and prolapse), and perform an internal vaginal examination to assess pelvic floor muscle function. Based on the findings of the muscle assessment, the home exercise program will be formulated and the patient will practise a set of these exercises, with feedback from the physiotherapist. The exercises will be practised at home, either spread throughout the day, or done all together, depending on patient lifestyle and exercise ability.
Intervention code [1] 2481 0
Rehabilitation
Comparator / control treatment
Lifestyle advice (weight loss, chronic cough, heavy lifting and general exercise) will be provided.
ADDITIONAL INFORMATION: The lifestyle advice will be delivered via a brochure. This will be the same brochure delivered to the control group. Further customization of any relevant lifestyle risk factors will be provided (verbally, supplemented by written reminders if required) to patients in the treatment group, during the appointments with the physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 3752 0
Prolapse severity measured by pelvic organ prolapse quantification system (POP-Q).
Timepoint [1] 3752 0
Baseline, 6 months and 12 months post-randomisation.
Primary outcome [2] 3753 0
Pelvic floor muscle strength and endurance measured using manometric squeeze pressure.
Timepoint [2] 3753 0
Baseline, 6 months and 12 months post-randomisation.
Secondary outcome [1] 6337 0
Digital testing of pelvic floor muscle squeeze and lift measured in lying and standing positions, recorded using the International Continence Society strength scale.
Timepoint [1] 6337 0
Baseline, 6 months and 12 months post-randomisation.
Secondary outcome [2] 6338 0
Measurement of urogential hiatus using transperineal ultrasound.
Timepoint [2] 6338 0
Baseline, 6 months and 12 months post-randomisation.
Secondary outcome [3] 6339 0
Measurement of quality and endurance of a pelvic floor muscle contraction using transabdominal ultrasound.
Timepoint [3] 6339 0
Baseline, 6 months and 12 months post-randomisation.
Secondary outcome [4] 6340 0
Pelvic organ prolapse symptom score mesaured using a 7 item questionnaire.
Timepoint [4] 6340 0
Baseline, 6 months and 12 months post-randomisation.
Secondary outcome [5] 6341 0
Pelvic organ prolapse quality of life measured on a questionnaire.
Timepoint [5] 6341 0
Baseline, 6 months and 12 months post-randomisation.

Eligibility
Key inclusion criteria
Women over 18 years of age presenting with symptoms of prolapse to gynaecology clinics. Prolapse severity can be of stage 1, 2 or 3 in one or more compartments.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Stage 4 prolapse, previous treatment for prolapse (surgery, pessary within 12 months, or formal instruction in PFMT within 5 years), inability to comply with PFMT, pregnancy, severe vaginal atrophy(unless pre-treated with local oestrogen).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Suitable patients identified by gynaecologists will be referred to the study. Information will be provided to patients and baseline questionnaire and consent form posted to potential participants. On return of forms women will be assessed by a physiotherapist with regard to pelvic floor muscle function measures, then randomised to intervention or control groups by the Project Coordinator via the remote automated computer randomisation application at the Centre for Health Care Randomsied Trials (CHaRT) at the University of Aberdeen UK. Everyconsenting participant will be registered and given a unique trial number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Automated computer based randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
25/02/2011
Date of last data collection
Anticipated
Actual
13/04/2012
Sample size
Target
180
Accrual to date
Final
168
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment postcode(s) [1] 740 0
3168
Recruitment postcode(s) [2] 741 0
3053
Recruitment postcode(s) [3] 742 0
5011

Funding & Sponsors
Funding source category [1] 2997 0
Government body
Name [1] 2997 0
The National Health and Medical Research Council (NHMRC)
Country [1] 2997 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street, Parkville, Victoria (VIC) 3010
Country
Australia
Secondary sponsor category [1] 2704 0
Hospital
Name [1] 2704 0
The Royal Women's Hospital
Address [1] 2704 0
Grattan Street, Carlton Victoria (VIC) 3053
Country [1] 2704 0
Australia
Other collaborator category [1] 168 0
Other Collaborative groups
Name [1] 168 0
Nursing,Midwifery and Allied Health Professions Research Unit
Address [1] 168 0
Room K211, Buchanan House, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA.
Country [1] 168 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4956 0
Human Research Ethics Committee, Central Northern Adelaide Health Service
Ethics committee address [1] 4956 0
c/o The Queen Elizabeth Hospital Adelaide, PO Box 400 Woodville, South Australia (SA) 5011
ADDITIONAL INFORMATION: 28 Woodville Rd., Woodville, SA 5011.
Ethics committee country [1] 4956 0
Australia
Date submitted for ethics approval [1] 4956 0
23/11/2007
Approval date [1] 4956 0
24/12/2007
Ethics approval number [1] 4956 0
Ethics committee name [2] 4957 0
Human Research Ethics Committee, Southern Health
Ethics committee address [2] 4957 0
246 Clayton Road, Clayton Victoria (VIC)3168
Ethics committee country [2] 4957 0
Australia
Date submitted for ethics approval [2] 4957 0
05/12/2007
Approval date [2] 4957 0
09/01/2008
Ethics approval number [2] 4957 0
07217C
Ethics committee name [3] 4958 0
Human Research Ethics Committee, The Royal Women's Hospital
Ethics committee address [3] 4958 0
Grattan Street, Carlton Victoria (VIC) 3053
Ethics committee country [3] 4958 0
Australia
Date submitted for ethics approval [3] 4958 0
09/01/2008
Approval date [3] 4958 0
27/03/2008
Ethics approval number [3] 4958 0

Summary
Brief summary
This study is a randomised controlled trial investigating the effectiveness of physiotherapy supervised pelvic floor muscle training (PFMT) for pelvic organ prolapse. The hypothesis is that PFMT for prolapse will effective in reducing prolapse severity and symptoms.
Trial website
Trial related presentations / publications
Publications
1. Frawley HC, Sherburn M, Hagen S, Galea MP (2008) Pelvic organ prolapse physiotherapy. Australian and New Zealand Continence Journal 14 (2):50-51
2. Hagen, S., D. Stark, C. Glazener, S.Dickson, S. Barry, A. Elders, H. Frawley, M. Galea, J. Logan, A. McDonald, G. McPherson, K. Moore, J. Norrie, A. Walker, D. Wilson, (2014). "Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial." Lancet 383(9919): 796-806. (related study in UK, partially funded by NHMRC grant).

Conference Presentations selected by peer-review
1. Frawley, H., Whitburn, L., Herbison, P., & Galea, M. (2012). Does e-recruitment affect retention and outcomes in a clinical trial? (abstract #600). International Urogynecology Journal, 23(8).
2. Frawley, H. C., Hagen, S., Sherburn, M., Neumann, P., Hay-Smith, J., Herbison, P., et al. (2012). Changes in prolapse following pelvic floor muscle training: a randomised controlled trial (abstract 163). Neurourol Urodyn, 31(6), 938-939.
3. Frawley, H. C., Hagen, S., Sherburn, M., Neumann, P., Herbison, P., Hay-Smith, J., et al. (2011). What is the relationship between pelvic floor muscle strength, prolapse stage and prolapse symptom severity? Neurourology and Urodynamics, 30(6), 862-863.
4. Frawley, H. C., Whitburn, L., Daly, J. O., & Galea, M. P. (2011). e-Recruitment: the future for clinical trials in a digital world? Neurourology and Urodynamics, 30(6), 811-812.
5. Mahfooza, A., Frawley, H., Galea, M., Hay-Smith, J., & Delany, C. (2011). Research participants' adherence and understanding: qualitative insights from a randomised controlled trial of conservative therapy for women with pelvic organ prolapse. Neurourology and Urodynamics, 30(6), 812-814.
6. Virtue, D., Sherburn M, Bryant, A., Frawley, Helena C., Galea, M.P. (2011). "A reliability study of two-dimensional transperineal ultrasound measurement of pelvic organ prolapse." Australian & New Zealand Continence Journal 17(4): 107.
Public notes

Contacts
Principal investigator
Name 28316 0
Prof Mary Galea
Address 28316 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC 3010
Country 28316 0
Australia
Phone 28316 0
+61 3 8387 2017
Fax 28316 0
Email 28316 0
[email protected]
Contact person for public queries
Name 11473 0
A/Prof Helena Frawley
Address 11473 0
Department of Physiotherapy
School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences
Monash University
Clayton VIC 3800
Country 11473 0
Australia
Phone 11473 0
+61 418 584 813
Fax 11473 0
Nil
Email 11473 0
[email protected]
Contact person for scientific queries
Name 2401 0
A/Prof Helena Frawley
Address 2401 0
Department of Physiotherapy
School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences
Monash University
Clayton VIC 3800
Country 2401 0
Australia
Phone 2401 0
+61 418 584 813
Fax 2401 0
Nil
Email 2401 0
[email protected]

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