None listed
Conditions
Brief summary
This project will assess the success (cure rate) of two types of suburethral sling procedures in the treatment of women with urodynamic stress incontinence and intrinsic sphincter deficiency. This group of patients has a low urethral closure pressure and is a challenging subgroup of patients that has shown less success in their treatment with other surgical methods (e.g. Burch colposuspension). The suburethral sling procedures (e.g. TVT) have shown better results in this group. The Monarc sling is a new procedure that places the tape in a different way (through the obturator foramen) as the TVT, which has been established for some time in the treatment of intrinsic sphincter deficiency. Therefore we will assess and compare the success and other outcomes (complication rate, hospital stay, etc) of both procedures.
Interventions
Insertion of tension free vaginal tape (retropubic sling), trans-obturator suburethral sling. Surgery for sling insertion takes 15-20 minutes, theatre session time varies due to commonly performed concommitant prolapse surgery. The study has a 3 year follow up period after surgery was performed.
Sponsors
Mercy Hospital for Women
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
urodynamics stress incontinence with intrinsic sphincter deficiency
Exclusion criteria
pelvic infection, voiding difficulty (defined at cystometry as maximum flow less than 15 mL per second or voiding pressure greater than 50 cm H2O or residual volume greater than 100 mL), inability to give informed consent
Outcome results
None listed