Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000597392
Ethics application status
Approved
Date submitted
14/08/2008
Date registered
1/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Double Blind randomised controlled trial assessing the effects of the cough-test versus no cough-test during the tension free vaginal tape procedure on post operative voiding difficulties.
Scientific title
Prospective Double blind randomised controlled trial assessing the effects of the cough-test versus no cough-test during the tension free vaginal tape procedure on postoperative voiding difficulties.
Universal Trial Number (UTN)
Trial acronym
To cough or not during TVT, A RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the TVT- Tension free vaginal tape is a suburethral sling operation for stress incontinence in women. 3097 0
Condition category
Condition code
Surgery 3256 3256 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The original tension free vaginal tape procedure was described using a cough test but the test has been abandoned by many. We are studying whether or not this is an important part of the procedure. Both groups undergo the tension free vaginal tape procedure. This involves the insertion of a suburethral tape passed from the vagina and brought out suprapubically attached to 2 needles which are then cut off the tape. The tape then provides support for the urethra when the abdominal and pelvic pressure is raised eg. during coughing or exercise and reduces or completely stops the severity of urine leaked.
The intervention group do not receive the cough test. The control group do. The cough test involves waking the patient up after the tape has been passed and asking them to cough. The tape is then adjusted to the surgeons satisfaction allowing a drop of urine to pass but no more during coughing. The intervention group takes approximately 10 to 15 mins less than the control group. The procedure take approximately 30 to 35 mins for the control group.
Intervention code [1] 2839 0
Treatment: Surgery
Comparator / control treatment
The active control group receive the standard cough test during the procedure.
Both groups undergo the tension free vaginal tape procedure.
the control group receive the cough test, the intervention group do not.
Control group
Active

Outcomes
Primary outcome [1] 4142 0
differences in postoperative voiding difficulties. these will be characterised by number of trials of voiding after the procedure, number of days to remove the catheter, incidence of urinary retention, incidence of clean intermittent self catheterisation, incidence of catheter reinsertion.
Timepoint [1] 4142 0
6 weeks, 6 months and 12 months post operative.
Secondary outcome [1] 6985 0
Post operative pad test is assessing the amount/severity of urine leakage
Timepoint [1] 6985 0
6 weeks, 6 months and 12 months postoperative
Secondary outcome [2] 6986 0
Flowmetry and ultrasound post void residuals are assessing the degree of difficulty experienced in trying to fully empty the bladder and confirming that the bladder is empty after micturition.
Timepoint [2] 6986 0
6 weeks, 6 months and 12 months postoperative.
Secondary outcome [3] 6987 0
Subjective disease specific quality of life questionnaires
Timepoint [3] 6987 0
6 weeks, 6 months and 12 months postoperative.

Eligibility
Key inclusion criteria
All patients with urodynamic and clinical evidence of mixed or stress incontinence.
Minimum age
21 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unwilling or unable to consent to study or who previously underwent a continence procedure. Patients who are unable to cough.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated code
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3374 0
Hospital
Name [1] 3374 0
St George Hospital
Country [1] 3374 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Gray Strret,
Kogarah,
NSW 2217
Country
Australia
Secondary sponsor category [1] 3019 0
None
Name [1] 3019 0
Address [1] 3019 0
Country [1] 3019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5399 0
South Eastern and Illawarra Area Health Service
Ethics committee address [1] 5399 0
St George Hospital
Gray Street,
Kogarah
NSW 2217
Ethics committee country [1] 5399 0
Australia
Date submitted for ethics approval [1] 5399 0
30/09/2005
Approval date [1] 5399 0
01/11/2005
Ethics approval number [1] 5399 0
05/95/Moore

Summary
Brief summary
The Tension Free Vaginal Tape Procedure (TVT) is the most commonly used procedure for women with stress incontinence worldwide. The cough-test (involving asking the patient to cough during TVT placement until no further leakage is seen) was originally described as being integral to the TVT procedure to improve outcomes and reduce post-operative voiding difficulties. Many gynaecologists now perform TVT insertion without the cough-test claiming similar outcomes, The proposed study is the first randomised trial comparing the differences in post-operative outcome between the TVT performed with an intra-operative cough-test and the same procedure without a cough test
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28559 0
Address 28559 0
Country 28559 0
Phone 28559 0
Fax 28559 0
Email 28559 0
Contact person for public queries
Name 11716 0
Dr Susmita Sarma
Address 11716 0
Pelvic Floor/Bladder Unit,
St George Hospital,
Belgrave Street,
Kogarah. NSW 2217
Country 11716 0
Australia
Phone 11716 0
02 9113 2272
Fax 11716 0
02 9113 3546
Email 11716 0
Sue.Sarma@SESIAHS.HEALTH.NSW.GOV.AU
Contact person for scientific queries
Name 2644 0
Associate Professor Kate Moore
Address 2644 0
Urogynaecology Department,
1st Floor Clinical Sciences Building
St. George Hospital, Gray St,
Kogarah, NSW 2217.
Country 2644 0
Australia
Phone 2644 0
02 9113 2054
Fax 2644 0
02 9113 3951
Email 2644 0
k.moore@unsw.edu.au

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

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