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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.
Assessment method [1] 0 0
A questionnaire about bladder symptoms
Timepoint [1] 0 0
Pre-operative compared to 12 months post-operative
Primary outcome [2] 0 0
Prolapse symptom (prevalence and bother) questionnaire.
Assessment method [2] 0 0
A questionnaire about prolapse symptoms
Timepoint [2] 0 0
Pre-operative compared to 12 months post-operative
Secondary outcome [1] 0 0
Pelvic floor muscle strength.
Assessment method [1] 0 0
Strength assessed via digital muscle testing
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Frawley HC, Phillips BA, Bo K, Galea MP. Physiothe... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00222326