RecruitingACTRN12616000328471

Comparison of the mini sling or retropubic sling in the treatment of women with severe (Intrinsic Sphincter Deficiency -ISD) stress urinary incontinence (SUI)

Objective cure rate of mini sling or retropubic sling in women with Intrinsic Sphincter Deficiency - a RCT study (Mini RISD)


Sponsor

Dr Lin Li Ow

Enrollment

152 participants

Start Date

Apr 21, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria2

  • 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.

Exclusion Criteria7

  • 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

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Interventions

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 comfirme

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.


Locations(2)

Mercy Hospital for Women - Heidelberg

VIC, Australia

Monash Medical Centre - Moorabbin campus - East Bentleigh

VIC, Australia

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ACTRN12616000328471


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