Modified Pilates as an adjunct treatment for urinary incontinence

ISRCTN	ISRCTN74075972
DOI	https://doi.org/10.1186/ISRCTN74075972
Secondary identifying numbers	12421

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

Not provided at time of registration

Contact information

Prof Berthold Lausen
Scientific

University of Essex
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom

Email	blausen@essex.ac.uk

Study information

Study design	Randomised interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a pilot study
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.
Ethics approval(s)	First MREC, 18/07/2012, ref: 12/EE/0241
Condition	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	1. Sympton severity index (SSI) 2. Incontinence related quality of life 3. Rosenberg self esteem index
Secondary outcome measures	No secondary outcome measures
Overall study start date	05/10/2012
Overall study end date	04/02/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	UK Sample Size: 100
Participant 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
Participant 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)
Recruitment start date	05/10/2012
Recruitment end date	04/02/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Essex

Colchester
CO4 3SQ
United Kingdom

Sponsor information

Colchester Hospital University NHS Foundation Trust (UK)
Hospital/treatment centre

Colchester General Hospital
Colchester District General Hospital
Charter Way Turner Road
Colchester
CO4 5JL
England
United Kingdom

Website	http://www.colchesterhospital.nhs.uk/

Funders

Funder type

Government

NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-1010-23220

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

03/07/2018: Publication reference added.
03/05/2016: No publications found, verifying study status with principal investigator.