Objectives: The objective of the study is to test the feasibility of the self-fixing mechanism of securing and placing tension on the fascia lata pubo-vaginal sling. This is a small feasibility study using descriptive statistics only. The feasibility of the anchoring system alone is being tested.
Methods: The study is a small single arm feasibility trial of five participants. The study is testing if a fascia lata pubo-vaginal sling can be successfully anchored using absorbable barbed suture using a suture passing trocar, thus avoiding a larger abdominal incision to tension the sling.
The inclusion criteria: adult women with urodynamic stress incontinence who would otherwise be candidates for a mid-urethral sling procedure. Exclusion criteria include incontinence other than pure stress, BMI >35, urinary retention with post-void residual volume >100 millilitres, or previous urinary tract or pelvic reconstructive surgery.
The procedure uses a sling of harvested fascia lata of 1.5-2 cm by 8-10 cm. The sling is affixed to a 2-0 PDS Stratafix Symmetric suture at each end. The sling is passed retropubically using a Caldera transvaginal suture passer and tensioned to allow for a gap between the urethra and the sling.
Follow-up procedures includes completion of the UDI-6 survey at baseline, 6 weeks and 6 months post-procedure. Examination is performed at 6 weeks post-op to assess for graft complications and to assess for urinary retention.
Data analysis is descriptive only. Feasibility outcomes include urinary retention, participant reported improvement, and technical issues in placement of the sling.
Results: All participants have completed the 6 month follow-up. All five participants reported being "greatly bothered" by urinary leakage at baseline. At 6 weeks follow-up, all 5 participants were "not at all" bothered by leakage with physical activity. Two participants were "greatly" bothered with difficult urination at 6 weeks of follow-up. By 6 month follow-up, one of five participants reported being "moderately" bothered with difficult urination, but was not having urinary retention. There were no technical issues in any case with the placement of the sling. One participant reported a bothersome bulge of the thigh from the graft harvest site.
Conclusions: The sling fixation method using an absorbable barbed suture successfully anchors the sling as evidenced by participant reported reduction in activity related urinary leakage at 6 months follow-up. Transient urinary retention is common but resolved in all participants by the 6-month follow-up assessment.
