The management of late complications of synthetic mid-urethral slings (MUS) typically involves two distinct steps: excision and subsequent treatment of recurrent stress urinary incontinence. The use of placental tissue (umbilical vessels) provides biocompatibility and good tolerance in nerve regeneration. The objective was to study the feasibility and tolerance of placing a placental sling in women simultaneously with the removal of a complicated synthetic MUS.
A pilot study (clinical trial # NCT05207189) including patients with complications of MUS requiring their removal was initiated in multiple French centers. Enrolled patients underwent the placement of a sling made from umbilical vessels (UVO), flattened, treated, and placed using the “pubo-vaginal sling” technique. They were all followed up at 15 days, 45 days, 3 months, 6 months, and 12 months. Tolerance, complications, continence (number of protection pads used over 3 days, voiding diary), and quality of life (ICIQ-UI-SF, UDI-6, and IIQ7) were assessed at each follow-up. In this study, we present interim results after the end of inclusions.
A total of 15 patients with an average age of 58 years (+/-14 years) were included and treated in this pilot study. The average time between the first surgery and the current surgery was 10 years +/- 6 years (min = 1, max = 21 years). Patients had an average (SD) pain level assessed (VAS) of 4.9 (4.0) before surgery, and ten patients (67%) had urinary incontinence. There were no serious unexpected events during the surgical procedure. 3 patients withdrawn the study within 3 months ( 2 for persistence of complications, and 1 for aggravation of incontinence) .Twelve (12) patients currently have a follow-up of more than 6 months . The average VAS was 1.8 (3.7). The mean (SD) UDI-6 was significantly reduced postoperatively (63.2 (21.7) versus 38.2 (27.6), p=0.024). The ICIQ-UI-SF and IIQ7 scores were also reduced, although not significantly.
These initial results show the potential of UVO as a second-line treatment after the failure of MUS in women with stress urinary incontinence. The procedure is well-tolerated with long-term effectiveness yet to be demonstrated. The role of UVO in women with stress urinary incontinence is still to be determined.
