Hypothesis / aims of study
4 million of Italian women over the age of 50 are affected by genital prolapse, in the world 400 million women suffer from this problem, which seriously affects their quality of life. Amongst the major causes of genital prolapse is trauma which follows the birth of a woman’s first child. It is estimated that around 50 percent of women who give birth experience pelvic floor damage.
THE AIM OF THE THIS STUDY WAS TO ASSESS the surgical and functional outcomes of single-incision vaginal surgery for the treatment of advanced pelvic organ prolapse (POP).
Study design, materials and methods
Thirty-five patients underwent surgery to treat their symptoms of POP (> stage II) according to the Pelvic Organ Prolapse Quantification System (POP-Q).
The primary objectives were the anatomical correction of anterior POP (> stage II), assessed by means of a vaginal examination and a translabial ultrasound, and resolution of cervico-urethral obstruction with elevated post-void residual assessed prior to surgery by means of urodynamic testing. Anatomical recovery was assessed via a vaginal examination using the ICS-POP-Q system. All of the patients had to complete a 72-hour void diary, they also had to undergo urodynamic testing and a perineal ultrasound with a 3.5 MHz probe positioned on the labia majora with the patient in a semi-supine position at rest and subsequently a dynamic transperineal assessment during Valsalva to measure the descent of the pelvic organs. Furthermore, they were given several questionnaires to complete assessed at baseline, at three months and 1 and 2 years after the surgery. We also assessed patient quality of life pre- and postoperatively. and with the use of a translabial ultrasound to assess the correct position of the mesh. The subjective outcome was measured using questions 2 and 3 of the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6). We also assessed patient quality of life pre- and postoperatively.
Seventy-five women with cystocele (III%/ IV), underwent surgery using the single-incision technique via the transvaginal route. The intermediate follow-up was four years. Restorelle SmartMesh with the Digitex suture delivery system via a single-incision technique was used in all patients. All patients showed a significant improvement in terms of anatomical outcome after prolapse surgery (p <0.05), and there were no recurrences requiring further surgical intervention. The anatomical success coefficient was 96.3% with a significant improvement in quality of life (p <0.0001) and a significant reduction (58 vs 2.9%) in post-void residual. There was a simultaneous significant improvement in POPDI-6, UDI-6, IIQ-7, and PISQ-12 scores after surgery. There were no cases of mesh dislocation. No de novo dyspareunia was reported. No mesh extrusion has been reported to date. However, some patients have presented with stress urinary incontinence, for which three patients were treated via surgery.
Interpretation of results
This study has produced excellent results as regards both anatomical correction and quality of life for patients with advanced POP using Restorelle SmartMesh with a Digitex suture delivery system via a single-incision technique (SIMS). With the low incidence of mesh exposure and good anatomical results, SIMS could be considered an option for the treatment of advanced POP