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Welcome to OPAL 

 

Welcome to the OPAL trial website.

 

OPAL - Optimizing Pelvic Floor Muscle Exercises to Achieve Long term benefits

  

Summary of the Trial

Accidental urine leakage (incontinence) is a distressing problem that affects about 1 in 3 women, and the NHS spends large amounts of money treating it.

 Many women have stress incontinence; that is, accidental urine leakage that happens with coughing, sneezing and physical activity. Based on past research, current UK guidelines recommend that these women are offered at least three months of pelvic floor muscle exercises. The exercises are taught by a specialist physiotherapist or nurse. There is evidence that these exercises can strengthen the muscles and decrease leakage. It is not clear how "intensively" women have to exercise to get a good result that lasts thus improving the woman's quality of life and reducing the likelihood of surgery.

 Sometimes a technique called ‘electromyography’ biofeedback is used to help a woman perform the exercises. However it is uncertain whether using this technique makes the exercises more effective. This research aims to find out whether doing pelvic floor muscle exercises with biofeedback is any more effective than doing exercises without feedback.  

 

Who is eligible for the trial?

Women with a new episode of stress or mixed urinary incontinence can take part in the trial. The trial will involve 600 women from 14 centres within the UK.

 

What does the study involve?

All participants will be asked to attend 6 appointments over 16 weeks, with a continence physiotherapist or nurse. Half of the participants will be taught how to do pelvic floor muscle exercises and will be given a home exercise programme. The other half will, in addition, receive electromyography(EMG) biofeedback at clinic and will be provided with a small hand held EMG biofeedback unit to help with undertaking the exercises at home. During these appointments the continence physiotherapist or nurse will assess the participant’s condition, discuss their treatment goals and exercise plan, and monitor their progress. They will make sure the participant knows how to do the pelvic floor muscle exercises.

All participants will complete a daily exercise diary during their treatment and will complete a bladder diary at the study start and at 24 months into the study. Questionnaires will be sent for completion at the start of the study and 6, 12 and 24 months into the study.

All participants will be asked to attend for a follow-up assessment at 6 months.

 

 OPAL Participant Pathway

Who is doing the trial?

The OPAL trial is sponsored by Glasgow Caledonian University and  the research is being carried out by a group of experienced doctors, nurses, physiotherapists and researchers from a number of different organisations: 

  • Nursing, Midwifery and Allied Health Professions Research Unit
  • Glasgow Caledonian University, The University of Stirling,
  • Health Services Research Unit, University of Aberdeen
  • Centre for Healthcare Randomised Trials, University of Aberdeen
  • The University of Exeter,
  • The University of Otago, New Zealand
  • NHS Greater Glasgow & Clyde;
  • NHS Grampian
  • NHS Ayrshire and Arran
     
 
  

 

The study is funded by the National Institute for Health Research, Health Technology Assessment Programme.

 

  If you would like some more information about the trial please contact the OPAL trial team - Contact Us