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21 March 2013
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| [ Print-friendly version ] |
| Modified Pilates as an adjunct treatment for urinary incontinence |
| ISRCTN | ISRCTN74075972 |
| DOI | 10.1186/ISRCTN74075972 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Modified Pilates as an adjunct treatment for urinary incontinence |
| Scientific title | Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a pilot study |
| Acronym | N/A |
| Serial number at source | 12421 |
| Study hypothesis |
Urinary incontinence is a distressing condition affecting more than 5 million women in the UK. Treatment usually involves pelvic floor exercises (pelvic floor muscles are those that control continence mechanisms). More recently Modified Pilates (MP) has been suggested as an additional means of improving symptoms and the quality of life of sufferers. MP is a mind-body technique involving slow controlled movements focusing on posture and breathing.
However, no research has evaluated the effectiveness of MP in a group setting for patients suffering from urinary incontinence. To properly evaluate the effectiveness of MP a large randomised clinical trial will be necessary. In preparation we are planning a smaller (pilot) study to provide some early information, and help design the larger study. In the pilot study 100 women will be randomly assigned to two groups: Group 1 will receive pelvic floor exercises and lifestyle advice only Group 2 will attend a 6 week course of MP classes in addition to receiving pelvic floor exercises and lifestyle advice Participants in the two groups will be matched according to their height/weight ratio and severity of symptoms. Both groups will be assessed at the start of the study, when they have completed their treatment, and 5 months later. Measures will include severity of symptoms, frequency of incontinence, quality of life, self-and number of individual treatment sessions. Some participants will also be interviewed about their experiences of the treatments to explore perceived benefits and limitations. Findings will inform design of the larger trial, provide information about the feasibility of offering MP to this patient group, and produce preliminary findings about its effectiveness. Findings will be sent to patient and professional interest groups and to service commissioners. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12421 |
| Lay summary | Not provided at time of registration |
| Ethics approval | First MREC, 18 July 2012 ref: 12/EE/0241 |
| Study design | Randomised interventional study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Renal and Urogenital Disease |
| Participants - inclusion criteria |
1. Women aged 18 and over
2. Diagnosed with stress, urge, or mixed UI (defined by Abrams et al [25]) 3. Medically fit to perform physical activity |
| Participants - exclusion criteria |
1. Aged under 18 years
2. No UI diagnosis 3. Unable to actively contract pelvic floor muscles 4. Suffering faecal incontinence 5. Pregnant 6. History of pelvic malignancy 7. Received gynaecological surgery in previous 6 months 8. Given birth in previous 6 months 9. Disease of Central Nervous System (e.g. Multiple Sclerosis, Cerebrovascular accident) 10. Unable to walk without walking aid 11. Having insufficient mental capacity to complete questionnaires and/or follow exercise instructions (according to the principles of the Mental Capacity Act 2005) |
| Anticipated start date | 05/10/2012 |
| Anticipated end date | 04/02/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | UK Sample Size: 100 |
| Interventions |
Modified Pilates (MP)
Treatment usually involves pelvic floor exercises (pelvic floor muscles are those that control continence mechanisms). The intervention group receives pelvic floor exercises and modified pilates (MP). MP is a mind-body technique involving slow controlled movements focusing on posture and breathing. |
| Primary outcome measure(s) |
1. Sympton severity index (SSI)
2. Incontinence related quality of life 3. Rosenberg self esteem index |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-1010-23220 |
| Trial website | |
| Publications | |
| Contact name | Prof Berthold Lausen |
| Address |
University of Essex
Wivenhoe Park |
| City/town | Colchester |
| Zip/Postcode | CO4 3SQ |
| Country | United Kingdom |
| blausen@essex.ac.uk | |
| Sponsor | Colchester Hospital University NHS Foundation Trust (UK) |
| Address |
Colchester General Hospital
Colchester District General Hospital Charter Way Turner Road |
| City/town | Colchester |
| Zip/Postcode | CO4 5JL |
| Country | United Kingdom |
| Sponsor website: | http://www.colchesterhospital.nhs.uk/ |
| Date applied | 12/12/2012 |
| Last edited | 12/12/2012 |
| Date ISRCTN assigned | 12/12/2012 |
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