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Trial registered on ANZCTR


Registration number
ACTRN12616000328471
Ethics application status
Approved
Date submitted
29/02/2016
Date registered
14/03/2016
Date last updated
20/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the mini sling or retropubic sling in the treatment of women with severe (Intrinsic Sphincter Deficiency -ISD) stress urinary incontinence (SUI)
Scientific title
Objective cure rate of mini sling or retropubic sling in women with Intrinsic Sphincter Deficiency - a RCT study (Mini RISD)
Secondary ID [1] 288645 0
Nil known
Universal Trial Number (UTN)
U1111-1180-1666
Trial acronym
Mini RISD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress Urinary Incontinence 297824 0
Intrinsic sphincter deficiency 297907 0
Condition category
Condition code
Renal and Urogenital 297999 297999 0 0
Other renal and urogenital disorders
Surgery 298074 298074 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with SUI will be referred for urodynamics examination routinely to assess for urodynamic stress incontinence (USI). Once urodynamic stress incontince associated with ISD has been comfirmed, participants will be randomized to the minisling or retropubic sling.
Intervention - Insertion of a mini-sling for treatment of female urodynamic stress incontinence & intrinsic sphincter deficiency. The minisling is a single incision sling system with small integrated self-fixating tips that anchor into the obturator internus muscle.This operation will be performed by a urogynaecologist or urgynaecology fellow with at least 3 years experience and the procedure will take approximately half an hour. The outcome is to assess the objective cure rate (negative clinical cough stress test) at 6 months post-surgery.
Intervention code [1] 294063 0
Treatment: Devices
Intervention code [2] 294124 0
Treatment: Surgery
Comparator / control treatment
Comparator - Retropubic sling
A retropubic sling 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. This sling will treat stress incontinence by providing support to the urethra to prevent urinary leakage during times of increased abdominal pressure. This operation will be performed by a urogynaecologist or urgynaecology fellow with at least 3 years experience and the procedure will take approximately half an hour.
.
Control group
Active

Outcomes
Primary outcome [1] 297522 0
To assess the objective cure rate (negative clinical cough stress test) of the minisling against the retropubic sling at 6 months post-surgical treatment of female urodynamic stress incontinence & intrinsic sphincter deficiency

Timepoint [1] 297522 0
6 months post surgery
Secondary outcome [1] 321305 0
To assess composite outcome of immediate complications of the minisling against the retropubic sling eg number of passes of sling ( if bladder perforation was noted), bladder or urethral perforation, bowel perforation. These complications will be noted on the operating report by the surgeon and will be collected from the operation sheet.
Timepoint [1] 321305 0
Intra-operative
Secondary outcome [2] 321306 0
To assess composite outcome of short term post-operative complications of the minisling against the retropubic sling eg number of pain days, supra-pubic pain, urinary tract infection.
Tools used to assess pain
Pain Score (VAS 0 – 10) & Intensity (0 - 3) at 6 hours and discharge
Additional analgesia if pain score >5 or intensity greater than or equal to 2.
Tools used to assess for UTI
1 mid stream urine sample with a single colony count of > 10 power of 5
Timepoint [2] 321306 0
The pain score and intensity will be collected at 6 hours and at discharge and the incidence of supra-pubic pain and urinary tract infection 6 weeks post surgery
Secondary outcome [3] 321307 0
To evaluate the incidence of urinary urgency after both slings based on symptoms of urgency ( rushing to void) and frequency defined as a score >3 on the patient perception of intensity of urgency scale
Timepoint [3] 321307 0
6 months post surgery
Secondary outcome [4] 321308 0
To evaluate the incidence of voiding dysfunction after both slings based on symptoms of hesistancy, difficulty voiding, incomplete emptying of the bladder OR need for on-going use of a catheter to drain the bladder after 6months OR return to theatre for sling loosening or sling division.
Timepoint [4] 321308 0
6 months post surgery
Secondary outcome [5] 321309 0
To determine the subjective outcomes using validated symptoms questionnaire -Incontinence impact questionnaire - overactive bladder (ICIQ-OAB)
Timepoint [5] 321309 0
6 months post surgery
Secondary outcome [6] 321516 0
To determine the subjective outcomes quality of life using the incontinence impact questionnaire (IIQ7)
Timepoint [6] 321516 0
6 weeks post surgery
Secondary outcome [7] 321517 0
To determine global improvement using a patient global impression of improvement questionnaire (PGI -I)
Timepoint [7] 321517 0
6 months post surgery
Secondary outcome [8] 321518 0
To evaluate the change in sexual function using pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12), following both slings.
Timepoint [8] 321518 0
6 months post surgery
Secondary outcome [9] 321519 0
To compare cost effectiveness between the minisling against the retropubic sling using a cost utility approach to measure changes in QALY, using EQ5D13
Timepoint [9] 321519 0
2 years post surgery
Secondary outcome [10] 321596 0
To determine the impact of urinary incontinence using the Incontinence impact questionnaire - urinary incontinence (ICIQ UI SF)
Timepoint [10] 321596 0
6 months post surgery

Eligibility
Key inclusion criteria
All participants between the ages of 18-80 with urodynamic stress incontinence and intrinsic sphincter deficiency. (USI/ISD)
Capable of providing informed consent and able to return for follow up.
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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)
Recruiting surgeons will call a central telephone number and the urogynaecology nurse consultant who holds the randomization codes will notify surgeon of allocation. Patients are blinded to type of sling inserted. Sham dressing will be placed on the suprabubic area for participants with mini-sling
Blinding of the surgeon performing the surgery is not possible.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized with equal probability to minisling or retropubic sling using a central computer-generated random allocation. Subjects will be randomised in order of entry into the study.
Balanced baseline characteristics would minimise influence on potential confounders.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Assuming an objective cure rate of 79% from the retropubic sling with power of 80%, a sample size of 66 in each arm would be required to detect a clinical difference of 20%, using a one sided alpha of 0.05. Allowing for an attrition rate of 15%, we propose to recruit a total of 152 subjects for the trial
An interim analysis after the first 30 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 x2 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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5360 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 5361 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 12813 0
3165 - Bentleigh East
Recruitment postcode(s) [2] 12814 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 293009 0
Hospital
Name [1] 293009 0
Monash Health
Address [1] 293009 0
Pelvic Floor Unit
Monash Health
823-865 Centre Road, Bentleigh East, Vic 3165
Country [1] 293009 0
Australia
Funding source category [2] 293010 0
Hospital
Name [2] 293010 0
Mercy Health
Address [2] 293010 0
163 Studley Road
Heidelberg Vic 3084
Country [2] 293010 0
Australia
Primary sponsor type
Individual
Name
Dr Lin Li Ow
Address
Monash Moorabin Hospital, Level 2 Urodynamics room,
823-865 Centre Road Moorabin Victoria 3165
Country
Australia
Secondary sponsor category [1] 291829 0
Individual
Name [1] 291829 0
A/Prof Anna Rosamilia
Address [1] 291829 0
Suite 48, Cabrini Hospital
181-183 WAttletree Road
Malvern Vic 3144
Country [1] 291829 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294520 0
Monash Health
Ethics committee address [1] 294520 0
Research Support
Services
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 294520 0
Australia
Date submitted for ethics approval [1] 294520 0
10/01/2016
Approval date [1] 294520 0
18/04/2016
Ethics approval number [1] 294520 0
Ethics committee name [2] 294521 0
Mercy Health
Ethics committee address [2] 294521 0
163 Studley Road
Heidelberg Victoria 3084
Ethics committee country [2] 294521 0
Australia
Date submitted for ethics approval [2] 294521 0
10/01/2016
Approval date [2] 294521 0
Ethics approval number [2] 294521 0
18/04/2016

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. 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. Comparative trials of retropubic against transobturator slings have shown retropubic slings to be superior in the cure rates of women with intrinsic sphincter deficiency (a severe form of stress urinary incontinence – ISD) .

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.

The retropubic sling comes with superior efficacy, but has higher risks of pelvic hematoma, bladder perforations, denovo urgency and voiding dysfunction. Minislings, placed under more tension, may provide equivalent or better results than retropubic slings in patients with ISD, whilst retaining the advantages of transobturator slings.

We seek to examine if the minisling is as efficacious as the retropubic sling for women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD) and compare their clinical outcomes.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63974 0
A/Prof Anna Rosamilia
Address 63974 0
Monash Health Pelvic Floor department
Suite 48, 183 Wattletree Rd, Malvern VIC 3144
Country 63974 0
Australia
Phone 63974 0
+6139509 6500
Fax 63974 0
+613 95096376
Email 63974 0
annarosamilia@urogyn.com.au
Contact person for public queries
Name 63975 0
Ms Alison Leitch
Address 63975 0
Pelvic Floor Unit
Obstetrics and Gynaecology
Monash Medical Centre Moorabbin
823-865 Centre Road
Bentleigh East Vic 3165
Country 63975 0
Australia
Phone 63975 0
+613 99288588
Fax 63975 0
+613 99288338
Email 63975 0
Alison.Leitch@monashhealth.org
Contact person for scientific queries
Name 63976 0
Dr Lin Li Ow
Address 63976 0
Pelvic Floor Unit
Obstetrics and Gynaecology
Monash Medical Centre Moorabbin
823-865 Centre Road
Bentleigh East Vic 3165
Country 63976 0
Australia
Phone 63976 0
+613 99288588
Fax 63976 0
+613 99288338
Email 63976 0
owlinli@yahoo.com

No information has been provided regarding IPD availability
Summary results
No Results