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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082547
ACTR Number: ACTRN12608000113358
Trial Status: Registered
Date Submitted: 2/02/2008
Date Registered: 28/02/2008

Page 1

Public title: Pelvic Organ Prolapse Physiotherapy (POPPY)
ANZCTR registration 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: 
UTN:
Trial acronym: POPPY

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

Page 3

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: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

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

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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
Gender: Females
Healthy volunteers? 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).

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the 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.
Describe the 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
 The people analysing the results/data
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase Phase 2 / Phase 3
Anticipated or actual start date: 1/03/2008
Target sample size: 180
Recruitment status: Not yet recruiting

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Funding source:Government funding body e.g. Australian Research Council 
Name:The National Health and Medical Research Council (NHMRC) 
Address:GPO Box 1421, Canberra, ACT 2601 ADDITIONAL INFORMATION: Level 5, 20 Allara Street, Canberra ACT 2601 
Country:Australia 
Primary sponsor: University
Name: The University of Melbourne
Address: Grattan Street, Parkville, Victoria (VIC) 3010
Country: Australia
Secondary sponsor:Hospital 
Name:The Royal Women's Hospital 
Address:Grattan Street, Carlton Victoria (VIC) 3053 
Country:Australia 
Other collaborator:Other Collaborative groups 
Name:Nursing,Midwifery and Allied Health Professions Research Unit 
Address:Room K211, Buchanan House, Glasgow Caledonian University, Cowcaddens Road, Glasgow G4 0BA. 
Country:United Kingdom 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Human Research Ethics Committee, Central Northern Adelaide Health Service 
Address:c/o The Queen Elizabeth Hospital Adelaide, PO Box 400 Woodville, South Australia (SA) 5011 ADDITIONAL INFORMATION: 28 Woodville Rd., Woodville, SA 5011. 
Country:Australia 
Date of approval:24/12/2007 
HREC Number: 
Ethics Committee name 2:Human Research Ethics Committee, Southern Health 
Address:246 Clayton Road, Clayton Victoria (VIC)3168 
Country:Australia 
Date of approval:9/01/2008 
HREC Number:07217C 
Ethics Committee name 3:Human Research Ethics Committee, The Royal Women's Hospital 
Address:Grattan Street, Carlton Victoria (VIC) 3053 
Country:Australia 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Postcode:3168, 3053, 5011 
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:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Helena Frawley
Address: School of Physiotherapy, The University of Melbourne, Parkville Victoria (VIC) 3010.
Country: Australia
Tel: 03 8344 4837
Fax: 03 8344 4188
Email: h.frawley@unimelb.edu.au

Contact person for scientific queries
Name: Helena Frawley
Address: School of Physiotherapy, The University of Melbourne, Parkville.
Victoria (VIC) 3010.
Country: Australia
Tel: 03 8344 4837
Fax: 03 8344 4188
Email: h.frawley@unimelb.edu.au

Contact person responsible for updating information
Name: Mary Galea
Address: School of Physiotherapy, The University of Melbourne, Parkville
Victoria (VIC) 3010.
Country: Australia
Tel: 03 8344 4171
Fax: 03 8344 4188
Email: m.galea@unimelb.edu.au
   
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