A pilot study to evaluate the effectiveness of dynamic lumbo-pelvic stability training as a treatment strategy for women with stress incontinence: a randomised controlled trial

ISRCTN ISRCTN27633617
DOI https://doi.org/10.1186/ISRCTN27633617
Secondary identifying numbers N0544139651
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
29/05/2014
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
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Amanda Savage
Scientific

Physiotherapy dept
Box 185
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone +44 (0)1223 216633

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesIs a program of dynamic lumbo-stability training (modified Pilates) an effective strategy to reduce symptoms in women with stress urinary incontinence?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Stress incontinence
Intervention1. 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date19/12/2003
Completion date18/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaParticipants 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment19/12/2003
Date of final enrolment18/12/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Physiotherapy dept
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Cambridge Consortium - Addenbrookes (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan