The vaginal wall sling:long term functional outcomes in the FDA's era

Costantini E1, Marchesi A1, Illiano E1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 772
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Stress Urinary Incontinence Quality of Life (QoL) Surgery Urgency Urinary Incontinence
1.Andrology and urogynecological Clinic,Santa Maria Hospital,Terni,University of Perugia
Links

Abstract

Hypothesis / aims of study
The vaginal wall sling, originally reported by Raz et al. in 1989 has the advantage of being autologous, so it is unlikely to degenerate. It involves construction of a sling from the anterior vaginal wall to provide compression and support for the mid-urethra and bladder neck. The vaginal sling for years it has been considered an excellent surgical approach to urinary incontinence in patients with a sphincter deficit who may or may not also be affected by urethral hypermobility. With the introduction of synthetic slings on the market, these techniques have been abandoned. However as a result of the warnings issued by the FDA in 2008 and 2011on the use of meshes in the framework of prolapse surgery, the manufacturers had no option but to also stop the production and marketing of mesh-supported products for the treatment of urinary incontinence. In some countries it has returned to use the vaginal wall sling.The primary aim of this study was to evaluate the long term functional outocomes of vaginal wall sling.The secondary aim was to evaluate the patient’s satisfaction.
Study design, materials and methods
This was a prospective single centre study, on patients with stress incontinence (SUI) related to ISD underwent in situ vaginal sling surgery.Inclusion criteria were severe incontinence, assessed according to the ICS criteria and graded according to the SEAPIQMN classification, VLPP <60 cm H20 and/or MUCP <30 cmH20. Hypermobility (27 patients) was not a contraindication.Pre opeative evaluation included:history,clinical examination,urodynamic test, transrectal dynamic ultrasound.All patients completed Urogenital distress inventory questionnaire short form. The sling was fashioned by making two horizontal and two vertical incisions, placed to form a rectangle, on the anterior vaginal wall. The proximal horizontal incision was at the level of the bladder neck and the distal was about 1 cm posterior to the urethral meatus. The vertical incisions completed the rectangular vaginal segment (15–20·25 mm).After preparing the sling, the proximal anterior vaginal wall edge was undermined beneath the bladder neck and the posterior bladder wall to prepare it to cover the vaginal island. After this first step, dissection was continued along the lateral edges of the sling toward the inferior pubic ramus and the endopelvic fascia was opened. Helicoidal sutures in 0-non-reabsorbable monofilament were positioned on each side of the sling. In all cases a fine roll of one small Marlex mesh was inserted within the helicoidal suture on each edge of the sling to ensure reinforcement and to prevent tissue pull-through and suture detachment from the sling. Cystoscopy was used to check that there was no bladder or urethral injury, assess bladder neck support and ensure adequate urethral compression. The two suprapubic sutures were tied above the rectus fascia; typically, one finger can be easily placed between the knot and the underlying rectus fascia. All patients underwent check-ups 1, 3, 6 and 12 months post-operatively and then annually.The post operative evaluation included the preoperative protocol except for urodynamic test.They performed uroflowmentry.At last visit patients completed also the Patient Global Impression of Improvement (PGI-I) questionnaire.The study protocol was approved by the Internal Review Board.
Results
From May 1996 to May 2002, 40 consecutive women underwent to vaginal sling surgery for SUI. Six patients were lost to follow-up and 12 had passed away: the remaining 20 patients were re-evaluated between January 2019 and February 2019, and are included in this report. Median follow-up was 243.4 months (range 203.4 – 275.1 months). The 20 women ranged in age from 36 to 72 years (mean56±8.6). Table 1 showed the preoperative and postoperative functional data.After an inital improvment (1 year after surgery) at last visit there were the worsening of urinary symtoms.In particular after 1 postoperative year,the objective success rate was 55% and at last visit was 40%.Of the 12 failed patients 10 underwent further SUI surgery with synthetic sling, and 2 underwent pelvic rehabilitation .Storage symotoms increased (from 40 % to 75%), as did mixed urinary incontinence (from 35 % to 75%). De novo urgency occurred in 40% of cases. Voiding symptoms increased from 10% to 50%. De novo voiding symptoms appeared in 8 patients. These results were confirmed also low PGI-I score
Interpretation of results
Results have been extremely divergent in recent reports using the vaginal wall sling. The discrepancies may be linked to the diverse techniques.After one year all urinary symptoms get worse,with low objective succes rate.Probably  the failure after 12 months may be due to progressive loss of collagen and elastin from the endopelvic fascia, loss of striated muscle from the pubococcygeus muscle and development of site specific fascial tears.
Concluding message
In the FDA's warming Era many countries are withdrawing to perform the sling vaginal wall for SUI, but the long term outcomes are poor .These results should justify the use of synthetic slings which in expert hands can give better long-term functional outcomes and few complications
Figure 1 Table 1Preoparative and psotoperative functional outcomes after the vaginal wall sling
Disclosures
Funding none Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics Committee CEAS Umbria Helsinki Yes Informed Consent Yes