Modified Pilates as an adjunct treatment for urinary incontinence
| ISRCTN | ISRCTN74075972 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74075972 |
| Protocol serial number | 12421 |
| Sponsor | Colchester Hospital University NHS Foundation Trust (UK) |
| Funder | NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-1010-23220 |
- Submission date
- 12/12/2012
- Registration date
- 12/12/2012
- Last edited
- 03/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Berthold Lausen
Scientific
Scientific
University of Essex
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom
| blausen@essex.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a pilot study |
| Study objectives | 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. |
| Ethics approval(s) | First MREC, 18/07/2012, ref: 12/EE/0241 |
| Health condition(s) or problem(s) studied | Renal and Urogenital Disease |
| Intervention | 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. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Sympton severity index (SSI) |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 04/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 05/10/2012 |
| Date of final enrolment | 04/02/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Essex
Colchester
CO4 3SQ
United Kingdom
CO4 3SQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/01/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/07/2018: Publication reference added.
03/05/2016: No publications found, verifying study status with principal investigator.
