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Trial registered on ANZCTR


Registration number
ACTRN12611000844943
Ethics application status
Approved
Date submitted
8/08/2011
Date registered
10/08/2011
Date last updated
10/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised controlled trial comparing vaginal prolapse repair with and without Tensionfree Vaginal Tape (TVT) in women with severe genital prolapse and occult stress incontinence
Scientific title
A prospective randomised controlled trial comparing vaginal prolapse repair with and without Tensionfree Vaginal Tape (TVT) in women with severe genital prolapse and occult stress incontinence: Long term follow up
Secondary ID [1] 262776 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of occult stress urinary incontinence in conjunction with prolapse repair 270483 0
Condition category
Condition code
Surgery 270640 270640 0 0
Surgical techniques
Renal and Urogenital 270676 270676 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of TVT suburethral sling at time of prolapse repair. The TVT procedure (Gynecare, Ethicon Inc., Somerville, NJ) was performed as previously described by Ulmsten. The tape is passed from the vagina retropubically without tension. The tape is a permanent synthetic mesh. The procedure takes 10-15 min including cystoscopy to excluded any bladder perforation.
Intervention code [1] 267117 0
Treatment: Surgery
Intervention code [2] 269156 0
Treatment: Devices
Comparator / control treatment
The prolapse repair is performed according to surgeon preference and the participants need. The prolapse repair alone without suburethral sling insertion is the control arm.
Control group
Active

Outcomes
Primary outcome [1] 269368 0
Need for stress incontinence surgery after prolapse repair determined by symptomatic stress urinary incontinence as well as urodynamics stress incontinence demonstrated by the urodynamics test at 6 month follow up
Timepoint [1] 269368 0
any time after primary surgery for up to 10 years
Primary outcome [2] 269396 0
urodynamic stress incontinence at 6 month post surgery
Timepoint [2] 269396 0
6 months
Secondary outcome [1] 279459 0
subjective cure rate such as patient reports no symptoms of stress incontinence, report a numerical success score of greater than or equal to 80 out of 100, quality of life questionnaires (UDI 6 and IIQ7)
Timepoint [1] 279459 0
six month and 12 months post surgery, than yearly follow up to 5 years
Secondary outcome [2] 287547 0
intra- and post-operative complications such as haemorrhage requiring blood transfusion, visceral damage, voiding difficulty, pain (immediate at the time of surgery, short term complications in the first 6 weeks, postoperatively and long-term)
Timepoint [2] 287547 0
immediate, first 6 weeks, six month and 12 months post surgery, than yearly follow up to 5 years
Secondary outcome [3] 287549 0
urgency and urge incontinence, assessed by history and bladder diary.
Timepoint [3] 287549 0
six month and 12 months post surgery, than yearly follow up to 5 years

Eligibility
Key inclusion criteria
pelvic organ prolapse = / > Grade 2, requiring surgical correction in absence of SUI and with urodynamically demonstrated OSI. Ability to give informed consent and willingness to participate are required
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to surgery in general such as being medically unfit for surgery, the presence of pelvic infection, malignancy, fistula, congenital or neurogenic bladder disorder, and 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)
central randomisation by phone /fax /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomization to either recieve the TVT suburethral sling at the time of prolapse repair or have prolapse repair alone.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269598 0
Self funded/Unfunded
Name [1] 269598 0
Address [1] 269598 0
Country [1] 269598 0
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Road
Heidelberg
Vic 3084
Country
Australia
Secondary sponsor category [1] 266632 0
Hospital
Name [1] 266632 0
Monash Medical Centre
Address [1] 266632 0
246 Clayton Road
Clayton
Vic 3168
Country [1] 266632 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269551 0
HREC Mercy Hospital for Women
Ethics committee address [1] 269551 0
163 Studley Rd
Heidelberg , Vic 3084
Ethics committee country [1] 269551 0
Australia
Date submitted for ethics approval [1] 269551 0
Approval date [1] 269551 0
02/05/2003
Ethics approval number [1] 269551 0
R03/06

Summary
Brief summary
Genital prolapse is a common condition with at least 1 woman in 10 undergoing surgery for this condition. It may be associated with urinary stress incontinence. Paradoxically, women suffering of severe genital prolapse may be continent. By reducing the prolapse during urodynamic assessment (barrier test), one can unmask urinary stress incontinence, called occult stress incontinence (OSI). Reducing the prolapse during urodynamic testing aims at mimicking the postoperative state. It is however unclear from the literature whether a positive barrier test is an indication for anti-incontinence surgery performed at the same time as prolapse surgery. Tensionfree Vaginal Tape (TVT) is an efficient anti-incontinence procedure and can be easily performed at the same time as prolapse surgery. Our study intends to randomise patients undergoing surgery for severe prolapse in two groups, one with usual prolapse surgery without any anti-incontinence procedure, the second with prolapse surgery and TVT.
Urodynamics studies on patients with severe prolapse describe 36 to 80% of OSI. Our hypothesis is that 50% of patients operated for prolapse with a positive barrier test will develop urinary stress incontinence. TVT cures or improves stress incontinence in about 90% of patients. Combining TVT with prolapse surgery may therefore reduce the post-operative rate of stress incontinence from 50% to 10%. However, systematic use of TVT may expose patients to complications like voiding difficulties or de novo detrusor instability. The other option is to operate patients for prolapse and perform TVT under local anaesthesia only in those who develop distressing stress incontinence post-operatively.
Trial website
Trial related presentations / publications
Abstract presented at International Urogynecology Association and International Continence Society 2010 Joint Annual Scientific Meeting, August 23-27. 2010, Toronto, Canada
Public notes

Contacts
Principal investigator
Name 32974 0
Address 32974 0
Country 32974 0
Phone 32974 0
Fax 32974 0
Email 32974 0
Contact person for public queries
Name 16221 0
Dr. Lore Schierlitz
Address 16221 0
Mercy Hospital for Women
163 Studley Rd
Heidelberg
Vic 3084
Country 16221 0
Australia
Phone 16221 0
61 3 84584890
Fax 16221 0
Email 16221 0
lschierlitz@mercy.com.au
Contact person for scientific queries
Name 7149 0
Dr. Lore Schierlitz
Address 7149 0
Mercy Hospital for Women
163 Studley Rd
Heidelberg
Vic 3084
Country 7149 0
Australia
Phone 7149 0
61 3 84584890
Fax 7149 0
Email 7149 0
lschierlitz@mercy.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary