Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Berthold Lausen

ORCID ID

Contact details

University of Essex
Wivenhoe Park
Colchester
CO4 3SQ
United Kingdom
blausen@essex.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12421

Study information

Scientific title

Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a pilot study

Acronym

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

Ethics approval

First MREC, 18 July 2012 ref: 12/EE/0241

Study design

Randomised interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Sympton severity index (SSI)
2. Incontinence related quality of life
3. Rosenberg self esteem index

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/10/2012

Overall trial end date

04/02/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

UK Sample Size: 100

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

United Kingdom

Trial participating centre

University of Essex
Colchester
CO4 3SQ
United Kingdom

Sponsor information

Organisation

Colchester Hospital University NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes