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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00222326




Registration number
NCT00222326
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
3/05/2021

Titles & IDs
Public title
The Effect of Physiotherapy Treatment Following Gynaecological Surgery
Scientific title
The Effect of a Physiotherapy Treatment Program on Pelvic Function Following Gynaecological Surgery
Secondary ID [1] 0 0
08-15-10-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaginal Hysterectomy 0 0
Pelvic Organ Prolapse Vaginal Surgery 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Pelvic floor muscle training - Pelvic floor muscle training: clinic and rooms exercise training

No intervention: Usual care - Usual care as provided by the surgeon and hospital staff
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bladder symptom (prevalence and bother) questionnaire.
Timepoint [1] 0 0
Pre-operative compared to 12 months post-operative
Primary outcome [2] 0 0
Prolapse symptom (prevalence and bother) questionnaire.
Timepoint [2] 0 0
Pre-operative compared to 12 months post-operative
Secondary outcome [1] 0 0
Pelvic floor muscle strength.
Timepoint [1] 0 0
Pre-operative compared to 12 months post-operative

Eligibility
Key inclusion criteria
* undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* surgery for malignancy
* anti-incontinence surgery
* laparotomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
School of Physiotherapy, The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. It is also known that problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgery phase when tissue repair and scar formation are critical, it is proposed that there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic floor muscle training and behavioural therapy program with a control group. It is hypothesised that at the 12 month post-operative follow-up assessment, the treatment group will demonstrate better outcomes in bladder and bowel function and control, as well as stronger pelvic floor muscle contractile strength than the control group.
Trial website
https://clinicaltrials.gov/study/NCT00222326
Trial related presentations / publications
Frawley HC, Galea MP, Phillips BA. Survey of clinical practice: pre- and postoperative physiotherapy for pelvic surgery. Acta Obstet Gynecol Scand. 2005 May;84(5):412-8. doi: 10.1111/j.0001-6349.2005.00776.x.
Frawley HC, Phillips BA, Bo K, Galea MP. Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2010 Jun;29(5):719-25. doi: 10.1002/nau.20828.
Public notes

Contacts
Principal investigator
Name 0 0
Mary P Galea, PhD
Address 0 0
The University of Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00222326