Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000596303
Ethics application status
Not yet submitted
Date submitted
20/06/2008
Date registered
1/12/2008
Date last updated
1/12/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cystocele and Stress Urinary Incontinence(SUI):Simultaneous repair (Sim-Pair) by a modified surgical technique using transobturator mesh -Prospective study
Scientific title
Cystocele and Stress Urinary Incontinence(SUI):Simultaneous repair (Sim-Pair) by a modified surgical technique using transobturator mesh -Prospective study
Universal Trial Number (UTN)
Trial acronym
SIM-PAIR study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 3293 0
Vaginal wall prolapse 3294 0
Condition category
Condition code
Surgery 3455 3455 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Simultaneous repair of cystocoele and treatment of SUI using Transobturator Mesh system(Perigee) via anterior vaginal wall incision and 4 exit points in the crural fold bilaterally (2 on each side). Patients are then followed up for a total of 24 months.
Intervention code [1] 3032 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4352 0
Absence of Urodynamic stress incontinence(USI) and less than Stage 2 prolapse using Pelvic Organ Prolapse Quantification (POP-Q).
Timepoint [1] 4352 0
Outcome is measured at baseline.Follow up at 3,6,12,24 months after surgery
Secondary outcome [1] 7334 0
Operation time
Timepoint [1] 7334 0
On the day of operation
Secondary outcome [2] 7335 0
Length of hospital stay
Timepoint [2] 7335 0
From day of surgery until discharge
Secondary outcome [3] 7336 0
Intra and postoperative complications; eg haemorrhage, infection, bladder and urethral injury, voiding dysfunction, mesh exposure or erosion.
Timepoint [3] 7336 0
Intraoperative and over the period 24 months of postoperative period
Secondary outcome [4] 7337 0
Quality of life questionnaires:Bristol Female lower urinary tract symptom (BFLUTS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
Timepoint [4] 7337 0
3,6,12,24 months after surgery
Secondary outcome [5] 7338 0
Patient subjective assessment of improvement; BFLUTS & PISQ.Main indicators being improvement of symptoms and quality of life.
Timepoint [5] 7338 0
3,6,12,24 months after surgery

Eligibility
Key inclusion criteria
Women presenting with stage 2 or more bladder prolapse (cystocele) and Stress Urinary Incontinence[revealed and occult] who desire reconstructive surgery,
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with less than stage 2 prolapseWomen who do not demonstrate SUIWomen with Intrinsic sphincter deficiency ( defined as maximum urethral closure pressure of more than orequal to 20 cm of water)Women less than 18 yrsWomen who decline participationWomen unable to give informed consentWomen with previous mesh based repair for bladder prolapse

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Single group
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
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3501 0
Other
Name [1] 3501 0
Pelvic health Education and Research
Country [1] 3501 0
Australia
Primary sponsor type
Other
Name
Pelvic health Education and Research
Address
P O Box 1417
Townsville QLD 4810
Country
Australia
Secondary sponsor category [1] 3144 0
None
Name [1] 3144 0
Address [1] 3144 0
Country [1] 3144 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5539 0
Ethics committee address [1] 5539 0
Ethics committee country [1] 5539 0
Date submitted for ethics approval [1] 5539 0
21/05/2008
Approval date [1] 5539 0
Ethics approval number [1] 5539 0

Summary
Brief summary
This is a study to assess the efficacy and safety of using one single mesh to treat both bladder prolapse and stress urinary incontinence as one operation.
We hope the cure of stress urinary incontinence(SUI) will be comparable to other meshes used to treat SUI alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28687 0
Address 28687 0
Country 28687 0
Phone 28687 0
Fax 28687 0
Email 28687 0
Contact person for public queries
Name 11844 0
Dr Kurinji Kannan
Address 11844 0
The Townsville Hospital
100 Angus Smith Drive Townsville QLD 4814
Country 11844 0
Australia
Phone 11844 0
+61747963759
Fax 11844 0
Email 11844 0
[email protected]
Contact person for scientific queries
Name 2772 0
Dr Kurinji Kannan
Address 2772 0
The Townsville Hospital
100 Angus Smith Drive Townsville QLD 4814
Country 2772 0
Australia
Phone 2772 0
+61747963759
Fax 2772 0
Email 2772 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.