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Trial registered on ANZCTR


Registration number
ACTRN12614000263695
Ethics application status
Approved
Date submitted
3/03/2014
Date registered
11/03/2014
Date last updated
11/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective study on determining position of Tension Free Vaginal Tape – Obturator (TVT-O) by Ultrasonography and associated urinary symptom
Scientific title
What is the position of Tension Free Vaginal Tape – Obturator (TVT-O) determined by Ultrasonography and the associated post-operative urinary symptoms in Chinese Women with urodynamic stress incontinence?
Secondary ID [1] 284191 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urodynamic Stress Incontinence 291293 0
The untrasonographic position of the Tension-Free Vaginal Tape Obsturator (TVT-O) and the associated urinary symptom 291294 0
Condition category
Condition code
Renal and Urogenital 291646 291646 0 0
Other renal and urogenital disorders
Surgery 291673 291673 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The recruited patient will have a transperineal ultrasound scan performed in order to determine the position of Tension Free Vaginal Tape - Obturator (TVT-O). This is a non-invasive procedure with no radiation exposure. The whole scan process will last for around 15 minutes. The recruited patient will have 2 scans after insertion of TVT-O treatment at post-operative 3rd and 6th months.
Intervention code [1] 288886 0
Early detection / Screening
Intervention code [2] 288911 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291573 0
The position of TVT-O in relation to urethra by perineal ultrasonography. During the scan, the distance between the tape and urethral longitudinal smooth muscle will be measured. Furthermore, the length of tape span in relation to the urethral length will also be measured.
Timepoint [1] 291573 0
Post-operative 3 and 6 months
Secondary outcome [1] 307091 0
The associated post-operative voiding symptom in relation to position of TVT-O determined by perineal ultrasounography. These data will be collected via Demographic and voiding symptom questionnaire.
Timepoint [1] 307091 0
Post-operative 3 and 6 months
Secondary outcome [2] 307092 0
Patient subjective satisfaction in relation to position of TVT-O determined by perineal ultrasonography. These data will be collected via the Visual Analogue Scale (VAS)
Timepoint [2] 307092 0
Post-operative 3 and 6 months
Secondary outcome [3] 307093 0
Quality of life improvement in relation to position of TVT-O determined by perineal ultrasonography. These data will be collected via the validated Incontinence impact questionnaire 7 (IIQ7) in Chinese format.
Timepoint [3] 307093 0
Post-operative 3 and 6 months

Eligibility
Key inclusion criteria
Age equal to or larger than 18 years old
Mentally fit for written informed consent
Diagnosed to have urodynamic stress incontinence by urodynamic study and patient chose to have TVT-O Consented for surgical treatment by TVT-O
Physically fit for transperineal ultrasound scan
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refuse or unable to give written consent
Psychiatric patient with cognitive impairment
Patient demanding tape excision for voiding dysfunction less than 3 months post-operation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presented with symptom of stress urinary incontinence with urodynamic study performed and confirmed diagnosis of Urodynamic Stress Incontinence (USI) will be counselled for TVT-O. If she agrees for operation, she will be inquired to join this study and sign the informed consent form at the same setting.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics for parameters on relation between TVT-O and urethra measured by ultrasounography
Student's T test to compare pre- and post-operative improvement on quality of life and sujective satisfaction
Logistic regression to find the association between the tape-urethral longitudinal smooth muscle distance and the post-operative voiding symptoms

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2014
Actual
Date of last participant enrolment
Anticipated
14/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 5859 0
Hong Kong
State/province [1] 5859 0

Funding & Sponsors
Funding source category [1] 288814 0
Self funded/Unfunded
Name [1] 288814 0
Chi Wai TUNG
Country [1] 288814 0
Hong Kong
Primary sponsor type
Individual
Name
Chi Wai TUNG
Address
Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, HONG KONG
Country
Hong Kong
Secondary sponsor category [1] 287509 0
None
Name [1] 287509 0
Address [1] 287509 0
Country [1] 287509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290659 0
Research Ethics Committee (Kowloon Central/ Kowloon East)
Ethics committee address [1] 290659 0
Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong
Ethics committee country [1] 290659 0
Hong Kong
Date submitted for ethics approval [1] 290659 0
01/10/2013
Approval date [1] 290659 0
15/11/2013
Ethics approval number [1] 290659 0
KC/KE-13-0164/ER-1

Summary
Brief summary
This study is carried out in Department of Obstetrics and Gynaecology of Queen Elizabeth Hospital. We will try to recruit all women presented with Udodynamic stress incontinence with Tension free vaginal tape - obturator done for joining this study.
Before the development of perineal ultrasound, the position of TVT-O is only determined by clinical experience and whether the post-operative voiding symptom is related or not is again determined by clinical experience. This study designed to determine the position of TVT-O at 3 and 6 months post-operatively and hence determine the associated urinary symptoms in order to study the relationship between the tape position and post-operative voiding symptoms.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 46658 0
Dr Chi Wai TUNG
Address 46658 0
Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, HONG KONG
Country 46658 0
Hong Kong
Phone 46658 0
+852-29582215
Fax 46658 0
Email 46658 0
[email protected]
Contact person for public queries
Name 46659 0
Chi Wai TUNG
Address 46659 0
Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, HONG KONG
Country 46659 0
Hong Kong
Phone 46659 0
+852-29582215
Fax 46659 0
Email 46659 0
[email protected]
Contact person for scientific queries
Name 46660 0
Chi Wai TUNG
Address 46660 0
Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, HONG KONG
Country 46660 0
Hong Kong
Phone 46660 0
+852-29582215
Fax 46660 0
Email 46660 0
[email protected]

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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