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Trial registered on ANZCTR

Registration number

ACTRN12617000167369p

Ethics application status

Not yet submitted

Date submitted

24/01/2017

Date registered

31/01/2017

Date last updated

29/01/2019

Date data sharing statement initially provided

29/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Mini sling or retropubic sling in women with Stress Urinary Incontinence - a Randomised Controlled Trial (Mini Retro)

Scientific title

Efficacy of mini sling versus retropubic sling in women with Stress Urinary Incontinence - a RCT study (Mini Retro)

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Mini Retro

Linked study record

Health condition

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

Stress urinary incontinence

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

To assess the subjective cure rate (positive answer to leaks when you cough or sneeze or leaks when physically active/exercising on ICIQ-UI) of the Altis minisling at 6 months post-surgical treatment of female urodynamic stress incontinence
This sling procedure for treatment of stress urinary incontinence is usually done as a day procedure and will take approximately half an hour. The sling is inserted at the midurethra to provide support during periods of increased intraabdominal pressure to prevent stress urinary incontinence. The Altis minisling is a single incision sling system with small integrated self-fixating tips that anchor into the obturator internus muscle. This potentially avoids complications associated with trocar passage through retropubic or transobturator route.This surgery will be done by a urogynaecologist

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

To assess the subjective cure rate (positive answer to leaks when you cough or sneeze or leaks when physically active/exercising on ICIQ-UI) of the tension free vaginal tape (TVT) retropubic sling at 6 months post-surgical treatment of female urodynamic stress incontinence
This sling procedure for treatment of stress urinary incontinence is usually done as a day procedure and will take approximately half an hour. The TVT differs from the altis minisling in the length of the sling and the way it is inserted. . The retropubic approach of the TVT involves tunneling the sling from the suburethral region, in close contact to the bladder in the retropubic space (behind the pubic bone), to the lower abdominal wall. Hence, clinically significant complications such as bladder injuries and haematoma have been reported. This surgery will be done by a urogynaecologist.

Control group

Active

Outcomes

Primary outcome [1]

To assess the subjective cure rate (positive answer to leaks when you cough or sneeze or leaks when physically active/exercising on ICIQ-UI) of the minisling against the retropubic sling

Timepoint [1]

6 months post-surgical treatment

Secondary outcome [1]

Proportion of participants with improvement in quality of life using quality of life questionnaires - PGI-I.

Timepoint [1]

6 months, 12 months and 24 months post surgery

Secondary outcome [2]

To assess immediate and short term post-operative complications of the minisling against the retropubic sling for example urinary tract infections based on self-report of participant, haematoma based on participant symptoms, clinical examination and ultrasound findings,,

Timepoint [2]

6 weeks post surgery

Secondary outcome [3]

To assess objective cure rate (negative cough stress test)

Timepoint [3]

6 months post surgical intervention

Secondary outcome [4]

To assess post-operative pain based on VAS scoring,

Timepoint [4]

6 weeks post surgery

Secondary outcome [5]

To determine the subjective outcomes of overactive bladder using validated symptoms questionnaires– ICIQ UI SF and ICIQ OAB,

Timepoint [5]

6 months, 12 months and 24 months post surgery

Secondary outcome [6]

To assess post-operative voiding dysfunction based on review of medical records

Timepoint [6]

6 weeks post surgery

Secondary outcome [7]

To assess length of hospital stay based on review of medical records,

Timepoint [7]

6 weeks post surgery

Secondary outcome [8]

To determine the impact on quality of life using the Incontinence impact questionnaire- IIQ7.

Timepoint [8]

6 months, 12 months and 24 months post surgery

Eligibility

Key inclusion criteria

All participants between the ages of 18-80 years with USI who have failed conservative management and have been placed on the surgical waitlist are eligible and would be offered to participate in the study.

Minimum age

18 Years

Maximum age

80 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Stress urinary Incontinence associated with intrinsic sphincter deficiency
Untreated Detrusor overactivity
Significant voiding dysfunction
Lower urinary tract anomaly (congenital)
Neurogenic bladder disorders
Previous radiation therapy to pelvis
Past history of any form of fistula involving the vagina
Allergy to polypropylene or local anaesthetic

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)

Prior to surgery, the surgeon will call the central number for allocation of the type of sling. A urogynaecology nurse consultant holds the randomization codes and will notify surgeon of allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

randomized with equal probability to Altis minisling or TVTTM retropubic sling using a central computer-generated random allocation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Interim analysis after the first 44 patients in each arm have completed 6 months of follow up: cessation of ongoing recruitment if minisling has greater than 25% difference in subjective cure rate compared with retropubic sling at 6months
Intention to treat analysis
Outcomes were compared with Pearson chi2 test for categorical data and Student t test or Wilcoxon rank-sum for continuous data as appropriate. 2 sided 95% confidence intervals will be used
Pre-operative & post-operative changes in ICIQ UI SF, ICIQ OAB ,PGI-I, IIQ7, PISQ-12, EQ5D were analysed using repeated measures analysis of variance ANOVA or Friedman test as appropriate
Incidence of subjective stress urinary incontinence symptoms (beyond 6 months) analysed using Kaplan Meier survival curves
Changes in EQ5D are used to derive changes in QALY for cost utility analysis

Recruitment

Recruitment status

Withdrawn

Reason for early stopping/withdrawal

Other reasons/comments

Other reasons

altis sling removed from market

Date of first participant enrolment

Anticipated

1/04/2017

Actual

Date of last participant enrolment

Anticipated

1/04/2019

Actual

Date of last data collection

Anticipated

1/04/2021

Actual

Sample size

Target

176

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Moorabbin campus - East Bentleigh

Recruitment postcode(s) [1]

3165 - East Bentleigh

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Coloplast Corp

Address [1]

1601 West River Road North, Minneapolis, MN 55411

Country [1]

United States of America

Primary sponsor type

Hospital

Name

Monash Health, Pelvic Floor Clinic

Address

865 Centre Road, Bentleigh East, Vic 3165

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Monash HREC

Ethics committee address [1]

Human Research Committee Ethics                                                                                                                                  Southern Health,                                                                                                                       
 246 Clayton Road, Clayton Vic 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/02/2017

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Stress incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Midurethral slings (MUS) have become the operation of choice for treatment of female stress urinary incontinence. MUS are synthetic tapes that are implanted transvaginally to support the urethra. The urethra is a tube that connects the bladder to the outside of the body and removes urine from the body.


Midurethral slings can be deployed in a retropubic or transobturator fashion. A retropubic approach involves tunneling the sling from the suburethral region, in close contact to the bladder in the retropubic space (behind the pubic bone), to the lower abdominal wall. In contrast, the transobturator approach involves the passage of a sling through the obturator membrane which is further away from the bladder. This approach has been shown to have a reduced rate of intra-operative bladder perforation.

Recent systematic reviews of retropubic or transobturator midurethral tapes suggest equivalent efficacy, at least in the medium term. Long term success rates of the retropubic approach are up to 91%. Both midurethral systems continue to have clinically significant complications such as bladder injuries, vagina mesh exposures, voiding difficulty, denovo (new onset) urgency and groin/thigh pain reported. Retropubic slings have more hematoma, bladder perforations, whereas transobturator slings have less over active bladder symptoms and less voiding difficulties. 

The minisling is a single incision sling system with small integrated self-fixating tips that anchor into the obturator internus muscle. This potentially avoids complications associated with trocar passage through retropubic or transobturator route.

Randomised trials of minislings against transobturator slings have shown similar results, with the added advantage of less overactive bladder symptoms and voiding difficulties. The self-fixating tips of the minislings allow them to be placed under more tension, whilst retaining the advantages of the transobturator sling. 

There have been no studies comparing the efficacy of the  retropubic sling with the minisling. Minislings may provide equivalent results as the retropubic sling with lower complication rates. We seek to examine if the minisling is as efficacious as the retropubic sling for women with urodynamic stress incontinence (USI) and compare their clinical outcomes.

Trial website

N/A

Trial related presentations / publications

N/A

Public notes

Contacts

Principal investigator

Name

Dr Lin Li Ow

Address

Monash Health Moorabin
865 Centre Road,
Bentleigh East
Vic 3165

Country

Australia

Phone

+613 9928 8588

Fax

+613 9928 8338

owlinli@yahoo.com

Contact person for public queries

Name

Alison Leitch

Address

Monash Health Moorabin
865 Centre Road,
Bentleigh East
Vic 3165

Country

Australia

Phone

+613 9928 8588

Fax

+613 9928 8338

alison.leitch@monashhealth.org

Contact person for scientific queries

Name

Lin Li Ow

Address

Monash Health Moorabin
865 Centre Road,
Bentleigh East
Vic 3165

Country

Australia

Phone

+613 9928 8588

Fax

+613 9928 8338

owlinli@yahoo.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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