Study design, materials and methods
This is a prospective randomised study on women who underwent L-CSP for symptomatic stage >2 POP in our tertiary urogynaecological centre. Exclusion criteria were previous POP or anti-incontinence surgery, and comorbidities such as diabetes or neurological disease.
Before surgery, all patients underwent urogynaecological work-up including: medical and urogynecological history, pelvic examination under straining in the gynaecological position using POP-Q classification; supine stress test with the prolapse reduced; conventional urodynamic study with and without prolapse reduction using a pessary; questionnaires: the short forms of Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6)  for urinary symptoms, and the Prolapse-Quality of Life Questionnaire (P-QoL) for QoL.
Patients were randomised to undergo L-CSP with total hysterectomy (Group 1) or with subtotal hysterectomy (Group 2)
Randomization was done using a computer-generated list. To ensure adequate concealment we use a one-site computer system combined with allocations kept in a locked, unreadable computer file that investigators can access only after the characteristics of an enrolled participant are entered.
Patients were followed up at 3, 6 and 12 months and thereafter annually, using the preoperative protocol, with the exception of urodynamic testing. Patients also completed the Patient Global Impression of Improvement (PGI-I) scale, a seven-point scale with a range of responses from 1 (very much improved) to 7 (very much worse) and the Visual Analog Scale (VAS).
The primary outcomes were: (i) anatomical results: objective cure was defined: as ‘good’ when points Ba, C and Bp (anterior, apical and posterior vaginal wall respectively) were at stage 0 at POP-Q; as ‘satisfactory’ at stage 1; as ‘failure’ at stage 2; (ii) safety: complications were evaluated according to the Clavien–Dindo classification. The grade III-a complications on the Clavien scale were evaluated further using the ICS/IUGA classification of mesh complications.
Secondary outcomes were: (ii) symptoms: presence or absence of storage, voiding, post-micturition and POP-related symptoms; (iii) QoL: score of 0–100 on P-QoL.
Assuming a two-sided hypothesis test with a 5% type 1error and 80% power, 45 patients in each group would be required to detect an absolute difference of 15% in reduction of complications. We sought to enrol 110 women in this clinical trial in order to allow for a 10% drop-out rate.
Institutional Review Board Committees approved this study (CEAS n. 1635). All participants gave informed consent. Patients with a minimum 24 months follow-up were included in this report.
Statistical analysis: McNemar Chi-square test, T-test, Mann–Whitney test. We considered p<0.05 to be statistically significant.
From September 2010 to September 2016, a total of 119 patients with symptomatic POP> stage 2 were enrolled. Of those, 100 patients were found to be eligible for our study: 50 were randomized in Group 1 and 50 were randomized in Group 2. At the last follow-up we lost to follow-up 4 patients in group 1 e 6 patients in group 2
No significant difference was found between groups in demographic data, degree of POP, and clinical or urodynamic findings.
We had a statistically significant anatomical correction in all vaginal segments in both groups. In particular in Group 1 we had a correction of anterior vaginal prolapse in 91.3% of patients, of central descensus in 93.5% and of posterior vaginal prolapse in 95.7%; in Group 2 we had a correction of anterior vaginal prolapse in 90.9% of patients, of central descensus in 93.2% and of posterior vaginal prolapse in 93.2%.
No intra-operative complications occurred in both groups. Vaginal mesh extrusion was observed in 5 patients in group 1. All 5 were treated with local therapy for three weeks: 3 had complete resolution, and 2 underwent surgical partial removal of the mesh and closure of the defect with complete resolution. No complications were observed in group 2.
Pre and post-operative symptoms of both groups are reported in Table 1.
Comparing post-operative data between the two groups, we found no differences between anatomical or symptomatic results (Table 2). In group 1 we had de novo UUI in 3 patients and de novo constipation in 2 patients. In group 2 we had de novo UUI in 4 patients, de novo dry OAB in 3 patients and de novo constipation in 2 patients
Quality of life was significantly improved in all domains in both groups, according to the King’s Health Questionnaire.
We observed a statistically significant differences between the two groups in the VAS score (mean value 8.84 in group 1 vs 9,45 in group 2 – p=.0263) and in PGI-I score (mean value 1.56 in group 1 vd 1.20 in group 2 – p=0046).
Interpretation of results
Both procedures provide significant anatomical correction of all vaginal segments, with a statistically significant improvement of the urinary symptoms and a good impact on QoL. The patients’ satisfaction was higher in group 2, and this is probably related with the absence of complications in this group.