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
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