Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 290997 0
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 301766 0
Condition category
Condition code
Renal and Urogenital 301454 301454 0 0
Other renal and urogenital disorders
Surgery 301467 301467 0 0
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] 296954 0
Treatment: Devices
Intervention code [2] 296969 0
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] 300851 0
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] 300851 0
6 months post-surgical treatment
Secondary outcome [1] 331017 0
To assess objective cure rate (negative cough stress test)
Timepoint [1] 331017 0
6 months post surgical intervention
Secondary outcome [2] 331018 0
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] 331018 0
6 weeks post surgery
Secondary outcome [3] 331024 0
Proportion of participants with improvement in quality of life using quality of life questionnaires - PGI-I.
Timepoint [3] 331024 0
6 months, 12 months and 24 months post surgery
Secondary outcome [4] 331027 0
To determine the subjective outcomes of overactive bladder using validated symptoms questionnaires– ICIQ UI SF and ICIQ OAB,
Timepoint [4] 331027 0
6 months, 12 months and 24 months post surgery
Secondary outcome [5] 331029 0
To determine the impact on quality of life using the Incontinence impact questionnaire- IIQ7.
Timepoint [5] 331029 0
6 months, 12 months and 24 months post surgery
Secondary outcome [6] 331151 0
To assess length of hospital stay based on review of medical records,
Timepoint [6] 331151 0
6 weeks post surgery
Secondary outcome [7] 331152 0
To assess post-operative pain based on VAS scoring,
Timepoint [7] 331152 0
6 weeks post surgery
Secondary outcome [8] 331153 0
To assess post-operative voiding dysfunction based on review of medical records
Timepoint [8] 331153 0
6 weeks 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?
No
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] 7371 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 15166 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 295421 0
Commercial sector/Industry
Name [1] 295421 0
Coloplast Corp
Country [1] 295421 0
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] 294240 0
None
Name [1] 294240 0
Address [1] 294240 0
Country [1] 294240 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296752 0
Monash HREC
Ethics committee address [1] 296752 0
Human Research Committee Ethics Southern Health,
246 Clayton Road, Clayton Vic 3168
Ethics committee country [1] 296752 0
Australia
Date submitted for ethics approval [1] 296752 0
15/02/2017
Approval date [1] 296752 0
Ethics approval number [1] 296752 0

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 71958 0
Dr Lin Li Ow
Address 71958 0
Monash Health Moorabin
865 Centre Road,
Bentleigh East
Vic 3165
Country 71958 0
Australia
Phone 71958 0
+613 9928 8588
Fax 71958 0
+613 9928 8338
Email 71958 0
[email protected]
Contact person for public queries
Name 71959 0
Ms Alison Leitch
Address 71959 0
Monash Health Moorabin
865 Centre Road,
Bentleigh East
Vic 3165
Country 71959 0
Australia
Phone 71959 0
+613 9928 8588
Fax 71959 0
+613 9928 8338
Email 71959 0
[email protected]
Contact person for scientific queries
Name 71960 0
Dr Lin Li Ow
Address 71960 0
Monash Health Moorabin
865 Centre Road,
Bentleigh East
Vic 3165
Country 71960 0
Australia
Phone 71960 0
+613 9928 8588
Fax 71960 0
+613 9928 8338
Email 71960 0
[email protected]

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.