Hypothesis / aims of study
Since 2008 Health authorities (FDA, Scottish government, UK’s National Institute for Health and Care Excellence, Australian Therapeutic Goods Administration, New Zealand’s Ministry of Health) have highlighted that the evidence of long-term efficacy is inadequate in quality and quantity and more studies to evaluate complications, and functional and anatomical outcomes are needed.
Some scientific recommendations are that transvaginal mesh (TVM) should only be used when other surgical procedures had previously failed or were expected to fail due to increased risks associated with the use of synthetic mesh (mesh exposure rates range from 4% to 19%).
The aim of the present study is to evaluate long-term follow-up safety and efficacy of TVM repair for the surgical treatment of pelvic organ prolapse (POP).
Study design, materials and methods
A prospective study was carried out in 97patients since 2010. All women had symptoms attributed to POP and the condition-specific POP quantification stage (POP-Q) ≥ II.
We evaluate clinical history, quality of life with QoL questionnaire, pelvic exploration based on POP-quantification (POP-Q), associated urinary incontinence (stress test with/without prolapse, use of pessary and urodinamics) and quality of sexual function . Primary endpoint was objective cure rate based on POP-Q system and patient satisfaction. An objective cure was defined as POP-Q stage 0, improvement as stage I. Failure was defined as stage II or greater. Adverse events during follow-up were also evaluated. We present data from patients with a follow-up over 5 years.
In all cases a Surelift kit (Neomedic Inc,USA) was used, six fixation point mesh with two points of fixation up to the sacrospinous ligament. Is a monofilament, type I macroporous mesh. All operations were performed by an experienced surgeon; using the same method of mesh insertion. In all cases an extra suspension of the apical compartment was performed at the end of the surgery to restore normal vaginal lenght. Local vaginal oestrogen preparation was not mandatory but recommended in all patients.
Results
97 patients were operated between 2010-2018. 77 patients involving anterior and middle compartment, 9 patients involving posterior and apical compartment and 11 patients involving all compartments. The mean age of the patients was 59 years. Mean parity 2.0 (range 1-8). Minimum follow-up period was 5 years.
Total mesh was used in 11 patients (11,1%), an isolated anterior mesh in 77 patients (77.7%) and an isolated posterior mesh in 9 patient (9.09%). Concomitant procedures were mid-urethral sling in 9 women, posterior colpoperineorraphy in 25 patients, and vaginal hysterectomy in 10 patients.
The mean POP-Q in the group of patients with anterior and middle repair was Aa 2, Ba 2, C 1, Ap -1, Bp -3, in those with posterior repair POP-Q was Aa -2, Ba-3, C0, Ap2, Bp 3; and in the group with a prolapse of the three compartments mean POP-Q was Aa2, Ba2, C2, Ap0, Bp1.
Up to 55% of patients have had previous surgical treatment of pelvic organ prolapse and a 26% had a concomitant diagnosis of some kind of urinary incontinence. Sexual relations were non satisfactory in 50% of the patients due to the prolapse.
Patient demographics and clinical characteristics are reported in Table 1.
All the surgeries were performed under locorregional anesthesia. The mean time of operation was 55minutes (range 42-117). 4 patients have had mild bleeding (<500cc) as an intra-operative complications, no other intra-operative complications were observed. There was no bladder or rectal perforation during the procedure. Acute urine retention was observed in 13 patients, hematoma in 7 and blood transfusion in 5 patients. Mean days of vaginal clogging was 2 days, mean bladder catheterization was 3 days and mean hospitalization was 3 days.
One year follow-up was performed in 85 patients. 90% achieved POP cure and 95,5% of the women were satisfied with the operation. 5 pacients have had vaginal complications. 4 patients have had a smaller exposure ( less than 1cm). 3 of them were asymptomatic (1A-3A) and 1 was symptomatic ( 1B-3B). All were exiced successfully at the outpatient clinic. 1 symtomatic larger extrusions was observed 4weeks after the surgery. It was due to a pelvic sponge left during the surgery. The sponge was successfully removed in the operating room Pre- and post-operative maximum flow rate and post-void residual were not different. The quality of sexual relations after the surgery was only asked in 47% of the patients, being satisfactory in 53% of them.
Mean vaginal lenght was 7 cm( range 6-9cm).
Five year follow-up was performed in 39 patients. 87% achieved POP cure and 93% report satisfaction about the surgery. No other new complications appear comparing with one year follw-up. Mean vaginal lenght was 7 cm( range 6-9cm)
One anf five years follow-uo data are in table 2.
Interpretation of results
Cure rates of the anterior, posterior and apical vaginal wall prolapse were about 87%, 87%% and 83% using SURELIFT® system with the median follow up of 5 years. Restoration of a good vaginal lenght was achieved.