None listed
Conditions
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.
Interventions
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 pr
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
Sponsors
Monash Health, Pelvic Floor Clinic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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
Outcome results
None listed