Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000093381
Ethics application status
Approved
Date submitted
15/02/2008
Date registered
18/02/2008
Date last updated
10/09/2023
Date data sharing statement initially provided
10/09/2023
Date results information initially provided
10/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled study to compare tension free vaginal tape (TVT) and Monarc trans-obturator tape (TOT) in the treatment of women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD).
Scientific title
A randomized controlled study to compare tension free vaginal tape (TVT) and Monarc trans-obturator tape (TOT) in the treatment of women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD).
Secondary ID [1] 263089 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intrinsic sphincter deficiency 2842 0
Best surgical correction 2843 0
Urodynamic stress incontinence 2844 0
Condition category
Condition code
Renal and Urogenital 2975 2975 0 0
Other renal and urogenital disorders
Surgery 2976 2976 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of tension free vaginal tape (retropubic sling), trans-obturator suburethral sling. Surgery for sling insertion takes 15-20 minutes, theatre session time varies due to commonly performed concommitant prolapse surgery. The study has a 3 year follow up period after surgery was performed.
Intervention code [1] 2572 0
Treatment: Surgery
Comparator / control treatment
Monarc transobturator tape/tension free vaginal tape
Both treatments are suburethral sling procedure used in the treatment of stress urinary incontinence. The TVT tension free vaginal tape is the tape procedure that has been used the longest (since 1996) while the obturator tape is a newer technique requiring further evaluation/ and comparison with the established TVT
Control group
Active

Outcomes
Primary outcome [1] 3851 0
subjective cure of urinary incontinence assessed with visual analog score, quality of life questionaires (UDI 6, IIQ 7)
Timepoint [1] 3851 0
6 months, longterm follow up 3 years post surgery
Primary outcome [2] 3852 0
need for repeat surgical treatment
Timepoint [2] 3852 0
6 months after primary procedure
Primary outcome [3] 3853 0
objective cure of urinary incontinence on urodynamics
Timepoint [3] 3853 0
6 months
Secondary outcome [1] 6486 0
surgical postoperative complication
Timepoint [1] 6486 0
first six weeks postoperative
Secondary outcome [2] 6487 0
longterm surgical complications
Timepoint [2] 6487 0
6 months, longterm follow up 3 years post surgery
Secondary outcome [3] 6488 0
surgical intra-operative complication
Timepoint [3] 6488 0
immediately

Eligibility
Key inclusion criteria
urodynamics stress incontinence with intrinsic sphincter deficiency
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
pelvic infection, voiding difficulty (defined at cystometry as maximum flow less than 15 mL per second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 mL), inability to give informed consent

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)
computer generated random allocation in a ratio of 1:1 to receiving a TVT or Monarc (TOT) as procedure to treat the incontinence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2004
Actual
3/03/2004
Date of last participant enrolment
Anticipated
Actual
12/02/2007
Date of last data collection
Anticipated
Actual
1/02/2019
Sample size
Target
182
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 772 0
3168
Recruitment postcode(s) [2] 773 0
3084

Funding & Sponsors
Funding source category [1] 3094 0
Hospital
Name [1] 3094 0
Mercy Hospital for Women
Country [1] 3094 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Road
Heidelberg 3084
Victoria
Country
Australia
Secondary sponsor category [1] 2785 0
Hospital
Name [1] 2785 0
Monash Medical Centre
Address [1] 2785 0
246 Clayton Road
Clayton 3168
Victoria
Country [1] 2785 0
Australia
Other collaborator category [1] 206 0
Hospital
Name [1] 206 0
Monash Medical Centre
Address [1] 206 0
246 Clayton Road
Clayton 3168
Victoria
Country [1] 206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5042 0
The Mercy Health and Age Care Human Research Ethics Commitee
Ethics committee address [1] 5042 0
Mercy Hospital for Women
163 Studley Road
Heidelberg 3084
Victoria
Ethics committee country [1] 5042 0
Australia
Date submitted for ethics approval [1] 5042 0
24/02/2004
Approval date [1] 5042 0
24/02/2004
Ethics approval number [1] 5042 0
04/04
Ethics committee name [2] 5043 0
Southern Health Human Research Ethics Commitee
Ethics committee address [2] 5043 0
Monash Medical Centre
246 Clayton Road
Clayton 3168
Victoria
Ethics committee country [2] 5043 0
Australia
Date submitted for ethics approval [2] 5043 0
Approval date [2] 5043 0
05/04/2004
Ethics approval number [2] 5043 0

Summary
Brief summary
This project will assess the success (cure rate) of two types of suburethral sling procedures in the treatment of women with urodynamic stress incontinence and intrinsic sphincter deficiency. This group of patients has a low urethral closure pressure and is a challenging subgroup of patients that has shown less success in their treatment with other surgical methods (e.g. Burch colposuspension). The suburethral sling procedures (e.g. TVT) have shown better results in this group. The Monarc sling is a new procedure that places the tape in a different way (through the obturator foramen) as the TVT, which has been established for some time in the treatment of intrinsic sphincter deficiency. Therefore we will assess and compare the success and other outcomes (complication rate, hospital stay, etc) of both procedures.
Trial website
Trial related presentations / publications
Three-Year Follow-Up of Tension-Free Vaginal
Tape Compared With Transobturator Tape in
Women With Stress Urinary Incontinence and
Intrinsic Sphincter Deficiency
Schierlitz L, Dwyer P, Rosamilia A, Murray C, Thomas E, Fitzgerald E, Hiscock R, De Souza A
Obstet Gynecol. 2012 Feb;119(2):321-327
Public notes

Contacts
Principal investigator
Name 28380 0
Dr Lore Schierlitz
Address 28380 0
Mercy Hospital for Women 163 Studley Road Heidelberg 3084 Victoria
Country 28380 0
Australia
Phone 28380 0
+61394161553
Fax 28380 0
Email 28380 0
[email protected]
Contact person for public queries
Name 11537 0
Dr Lore Schierlitz
Address 11537 0
Mercy Hospital for Women
163 Studley Road
Heidelberg 3084
Victoria
Country 11537 0
Australia
Phone 11537 0
03 -94161553
Fax 11537 0
Email 11537 0
[email protected]
Contact person for scientific queries
Name 2465 0
Dr Lore Schierlitz
Address 2465 0
Mercy Hospital for Women
163 Studley Road
Heidelberg 3084
Victoria
Country 2465 0
Australia
Phone 2465 0
03 -94161553
Fax 2465 0
Email 2465 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Effectiveness of tension-free vaginal tape compare... [More Details]
Study results articleYes Three-year follow-up of tension-free vaginal tape ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMid-urethral sling operations for stress urinary incontinence in women.2015https://dx.doi.org/10.1002/14651858.CD006375.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.