ANZCTR - Registration

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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]

MiniMo

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Female Stress Urinary Incontinence

Condition category

Condition code

Surgery

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]

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]

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]

6 months from intervention or comparator treatment

Secondary outcome [1]

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]

6 months from intervention or comparator treatment

Secondary outcome [2]

Timepoint [2]

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]

3084

Recruitment postcode(s) [2]

3165

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

American Medical System (AMS)

Address [1]

American Medical System World Headquarters
10700 Bren Road West
Minnetonka, Minnesota 55343

Country [1]

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]

Individual

Name [1]

Dr Anna Rosamilia

Address [1]

Dept Obstetrics & Gynaecology Monash Medical Centre, Centre Road, East Bentleigh, VIC 3165

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Yik N Lim

Address [2]

Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Dr Joseph Lee

Address [3]

Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Health Human Research Ethics Committee

Ethics committee address [1]

c/o adminstrative officer, Human Research Ethics Committee, 6th Floor, Mercy Hospital for Women, 163 Studley Road Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/11/2008

Approval date [1]

02/12/2008

Ethics approval number [1]

R08/43

Ethics committee name [2]

Southern Health Human Ethics Research Committee B

Ethics committee address [2]

Level 4 Main Block 246 Clayton Road Clayton 3168

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

04/11/2008

Approval date [2]

28/11/2008

Ethics approval number [2]

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

Dr Joseph Lee

Address

c/o Pelvic Floor Clinic, 823 Centre Rd East Bentleigh VIC 3165

Country

Australia

Phone

+61399288588

Fax

+61399288338

joseph.lee@southernhealth.org.au

Contact person for public queries

Name

Registered Nurse Elisabeth Thomas

Address

Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084

Country

Australia

Phone

+613 84584862

Fax

+613 84584878

ethomas@mercy.com.au

Contact person for scientific queries

Name

Dr Joseph Lee

Address

Dept Urogynaecology Mercy Hospital for Women 163 Studley Road Heidelberg VIC 3084

Country

Australia

Phone

+613 84584862

Fax

+613 84584878

joseph.lee@southernhealth.org.au

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

Source	Title	Year of Publication	DOI
Embase	Miniarc and monarc suburethral sling inwomenwith stress urinary incontinence-a randomised controlled trial.	2012	https://dx.doi.org/10.1007/s00192-012-1875-z
Embase	MiniArc Monarc suburethral sling in women with stress urinary incontinence-an RCT.	2013	https://dx.doi.org/10.1111/bju.12069
Embase	Miniarc monarc suburethral sling in women with stress urinary incontinence-an RCT-12 M follow up.	2013	https://dx.doi.org/10.1007/s00192-013-2101-3
Embase	Miniarc monarc suburethral sling in women with stress urinary incontinence-an RCT-24 M follow up.	2014	https://dx.doi.org/10.1007/s00192-014-2429-3
Embase	Outcomes of patients who declined randomization to MiniMo trial.	2015	https://dx.doi.org/10.1016/j.ejogrb.2015.09.015
Embase	Randomized trial of a single incision versus an outside-in transobturator midurethral sling in women with stress urinary incontinence: 12 month results.	2015	https://dx.doi.org/10.1016/j.ajog.2015.01.040

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically