Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000624381
Ethics application status
Approved
Date submitted
29/11/2008
Date registered
9/12/2008
Date last updated
26/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
MiniArc and Monarc suburethral sling in women with stress urinary incontinence - a randomised controlled trial
Scientific title
In female patients with Stress Urinary Incontinence, is MiniArc as good as Monarc in objective cure rates?
Secondary ID [1] 262922 0
MiniMo
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Stress Urinary Incontinence 4045 0
Condition category
Condition code
Surgery 4249 4249 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention treatment - MiniArc - Exitless transobturator placement of suburethral sling with fixation tip at obturator membrane. Intervention is - MiniArc placement of suburethral sling. Follow up is scheduled for 6 weeks, 6 months, 12 months, 24 months and 36 months.
Intervention code [1] 3767 0
Treatment: Surgery
Comparator / control treatment
Comparator: Monarc Device - Transobturator placement of suburethral sling using an outside in approach. Women who require surgery for stress urinary incontinence is eligible and is randmised to receive either MiniArc or Monarc. Duration of MiniArc Treatment: surgery should take no longer than it takes to perform Monarc. Follow up is scheduled for 6 weeks, 6 months, 12 months, 24 months and 36 months.
Control group
Active

Outcomes
Primary outcome [1] 5134 0
objective cure of stress urinary incontinence. Positive or negative clinical cough testing resulting in loss (positive) of urine during follow up clinical assessment
Timepoint [1] 5134 0
6 months from intervention or comparator treatment
Secondary outcome [1] 8643 0
subjective patient reported outcome using validated questionnaire International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI SF) and Patient Global Impression of Improvement (PGI-I)
Timepoint [1] 8643 0
6 months from intervention or comparator treatment
Secondary outcome [2] 305710 0
subjective patient reported outcome using validated questionnaire International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI SF) and Patient Global Impression of Improvement (PGI-I)
Timepoint [2] 305710 0
12 months, 24 months and 36 months from treatment

Eligibility
Key inclusion criteria
female patients with urodynamic stress incontinence
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
evidence of instrinsic sphincter deficiency
previous failed suburethral tapes
untreated detrusor overactivity, unfit for surgery, history genital tract malignancy or fistula, previous radiation to pelvis, known allergy to polypropylene

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)
randomisation through computer sequence generated table kept by nursing staff offsite
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer sequence generated random tables with stratification to recruiting sites
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/01/2009
Actual
30/04/2009
Date of last participant enrolment
Anticipated
Actual
14/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1320 0
3084
Recruitment postcode(s) [2] 1321 0
3165

Funding & Sponsors
Funding source category [1] 4223 0
Commercial sector/Industry
Name [1] 4223 0
American Medical System (AMS)
Country [1] 4223 0
United States of America
Primary sponsor type
Individual
Name
Professor Peter L Dwyer
Address
Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 3797 0
Individual
Name [1] 3797 0
Dr Anna Rosamilia
Address [1] 3797 0
Dept Obstetrics & Gynaecology Monash Medical Centre, Centre Road, East Bentleigh, VIC 3165
Country [1] 3797 0
Australia
Secondary sponsor category [2] 3798 0
Individual
Name [2] 3798 0
Dr Yik N Lim
Address [2] 3798 0
Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084
Country [2] 3798 0
Australia
Secondary sponsor category [3] 3799 0
Individual
Name [3] 3799 0
Dr Joseph Lee
Address [3] 3799 0
Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084
Country [3] 3799 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6278 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 6278 0
c/o adminstrative officer, Human Research Ethics Committee, 6th Floor, Mercy Hospital for Women, 163 Studley Road Heidelberg VIC 3084
Ethics committee country [1] 6278 0
Australia
Date submitted for ethics approval [1] 6278 0
04/11/2008
Approval date [1] 6278 0
02/12/2008
Ethics approval number [1] 6278 0
R08/43
Ethics committee name [2] 6311 0
Southern Health Human Ethics Research Committee B
Ethics committee address [2] 6311 0
Level 4 Main Block 246 Clayton Road Clayton 3168
Ethics committee country [2] 6311 0
Australia
Date submitted for ethics approval [2] 6311 0
04/11/2008
Approval date [2] 6311 0
28/11/2008
Ethics approval number [2] 6311 0
08188B

Summary
Brief summary
The purpose of this project is to evaluate the success of two types of surgical procedures in the treatment of women with exertional or activity related urinary incontinence, commonly brought on by coughing and sneezing. Modern advances involve development of minimally invasive procedures which saw the introduction of tension free vaginal tapes (TVT) and transobturator tape (e.g. Monarc) which provides good success rates when compared to the traditional operation, although with the advantage of a quicker recovery.
Both the TVT and Monarc tape have a success rates in the order of 85-90% but do attract complications such as bleeding and bladder injury (4-9%) at the time of needle passage, difficulty in passing urine, urinary urgency (2.9%), mesh material making its way through to the vagina (1%) or thigh pain.
The MiniArc sling is a procedure that places the tape in a different way. It is inserted through a small vaginal incision with no exit site and acts more as a “hammock”. It may have less complication than the Monarc slings because of its exitless design.
We aim to compare the success rate of MiniArc versus Monarc slings in treatment of female stress urinary incontinence with the hypothesis that MiniArc has at least the equivalent success rate
Trial website
Trial related presentations / publications
MiniArc and Monarc suburethral sling in women with stress urinary incontinence - a randomised controlled trial. Int Urogynecol J Pelvic Floor Dysfunct 2012; 23(Suppl 2):S142 – S144. BJU Int 2013; 111(S1): S15-S17

MiniArc and Monarc suburethral sling in women with stress urinary incontinence - a randomised controlled trial – 12m follow up. Int Urogynecol J Pelvic Floor Dysfunct 2013; 24(Suppl 1):S108– S109
Public notes

Contacts
Principal investigator
Name 29180 0
Dr Joseph Lee
Address 29180 0
c/o Pelvic Floor Clinic, 823 Centre Rd East Bentleigh VIC 3165
Country 29180 0
Australia
Phone 29180 0
+61399288588
Fax 29180 0
+61399288338
Email 29180 0
[email protected]
Contact person for public queries
Name 12337 0
Ms Registered Nurse Elisabeth Thomas
Address 12337 0
Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084
Country 12337 0
Australia
Phone 12337 0
+613 84584862
Fax 12337 0
+613 84584878
Email 12337 0
[email protected]
Contact person for scientific queries
Name 3265 0
Dr Dr Joseph Lee
Address 3265 0
Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084
Country 3265 0
Australia
Phone 3265 0
+613 84584862
Fax 3265 0
+613 84584878
Email 3265 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
SourceTitleYear of PublicationDOI
EmbaseRandomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results.2015https://dx.doi.org/10.1016/j.ajog.2015.01.040
EmbaseMiniarc and monarc suburethral sling inwomenwith stress urinary incontinence-a randomised controlled trial.2012https://dx.doi.org/10.1007/s00192-012-1875-z
EmbaseOutcomes of patients who declined randomization to MiniMo trial.2015https://dx.doi.org/10.1016/j.ejogrb.2015.09.015
EmbaseMiniarc monarc suburethral sling in women with stress urinary incontinence-an RCT-24 M follow up.2014https://dx.doi.org/10.1007/s00192-014-2429-3
EmbaseMiniarc monarc suburethral sling in women with stress urinary incontinence-an RCT-12 M follow up.2013https://dx.doi.org/10.1007/s00192-013-2101-3
EmbaseMiniArc Monarc suburethral sling in women with stress urinary incontinence-an RCT.2013https://dx.doi.org/10.1111/bju.12069
N.B. These documents automatically identified may not have been verified by the study sponsor.