Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
29/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Amanda Savage

ORCID ID

Contact details

Physiotherapy dept
Box 185
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 216633

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544139651

Study information

Scientific title

Acronym

Study hypothesis

Is a program of dynamic lumbo-stability training (modified Pilates) an effective strategy to reduce symptoms in women with stress urinary incontinence?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Urological and Genital Diseases: Stress incontinence

Intervention

1. Control Group will be taught standard static pelvic floor training exercises
2. Intervention Group will learn dynamic lumbo-pelvic stability training exercises (modified Pilates method)

Accessible participants will be informed about the research trial using a research subject information sheet submitted in a question and answer format.

Women not wishing to take part in the trial will be offered standard physiotherapy treatment through the normal patient booking procedures.

Consenting women will complete the Kings Health Questionnaire, a validated and reliable tool to measure stress incontinence symptoms and quality of life and attend the physiotherapy department for a full physiotherapy urogynaecological assessment with the chief investigator or a research assistant. A second, senior, postgraduate qualified physiotherapist will attend the urogynaecological assessment to perform a vaginal examination of the pelvic floor muscles and assessment of muscle action (strength and endurance) as is standard physiotherapy procedure. During this vaginal assessment all women will be taught correct pelvic floor muscle contraction, shown the extent of the muscle, cuing techniques will be used to maximise muscle recruitment. Fast contractions and slow contractions without accessory muscles or breath holding will be facilitated. The patient will be instructed how to self-examine the pelvic floor. Patients' questions about how to activate the pelvic floor will be answered.

After these cuing/teaching activities a final grade will be given for strength and endurance. The grading will be carried out using a reliable and validated method. The measurements will be recorded and kept securely but the chief investigator will not view the measurements until the analysis procedure at the end of the trial.

Those scoring Grade 0 ,1 or 2 on pelvic floor assessment will be unable to take part in the trial and will be offered the appropriate physiotherapy treatment of biofeedback/stimulation. Those scoring Grade 3, 4, or 5 on the Modified Oxford Scale will be invited to continue to randomisation.

Eligible, consenting women will be randomly allocated by computer-generated block allocation method to the control or intervention group. Both groups will be offered six physiotherapy training sessions over a 12-week period with the expectation that the patient will practice the training programme at home between training sessions. Training sessions will take place in the physiotherapy outpatient department. All training sessions will be conducted by the chief investigator or second researcher who have postgraduate training in both the training strategies. The control group will be taught standard static pelvic floor training exercises; the intervention group will learn dynamic lumbo-pelvic stability training exercises (modified Pilates method). Protocols describe the exact detail of the training methods to be used.

At 13 weeks the participants will be asked to complete a second Kings Health Questionnaire. The same physiotherapist who performed the baseline assessment of pelvic floor muscle action will complete a second vaginal examination of the pelvic floor muscles. The assessor will be masked to group allocation and participants will be advised not to discuss with the assessor the exercise program that they have been following.

Data collected will be anonymised and kept securely at all times. Results will be analysed on an intention-to-treat basis.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/12/2003

Overall trial end date

18/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be recruited from January 2004 to June 2004 subject to Local Research Ethics Committee approval. Women over 16 years referred to the Addenbrookes Hospital physiotherapy department with stress urinary incontinence will be invited to participate in the trial.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

19/12/2003

Recruitment end date

18/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiotherapy dept
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrookes (UK)

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

Additional files

Editorial Notes