The primary objective of this study was to evaluate the subjective and objective SUI cure rates. Secondary outcomes included effect on QoL and other urinary symptoms and late adverse events.

This is a single-centre prospective randomised study on women over 75 years who underwent mid-urethral sling [TVT (1) or ‘out-in’ TOT (2)] for stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI). All patients had undergone pelvic floor muscle training without success.
Exclusion criteria were: previous POP or SUI surgery; previous radical pelvic surgery; comorbidities such as diabetes or neurological disease; pelvic organ prolapse (POP) stage 2 or greater. 
All patients underwent a standardised pre-op work-up comprising: urogynecological history; pelvic examination using the POP-Q classification; standardised cough stress test (CST); a conventional urodynamic study (UDS) according to ICS criteria. 
SUI was defined according to ICS standardisation and classified according to the Ingelmann-Sundberg scale. Urinary symptoms were evaluated using the standardised questionnaire UDI-6. The King’s Health Questionnaire (KHQ) was used to evaluate QoL. Surgery was performed by the same expert surgeon.
Follow-up visits were scheduled for one month, six months, one year, then annually using the preoperative protocol, with the exception of urodynamic testing. Patients also completed the Patient Global Impression of Improvement (PGI-I) scale. We report results at 24 months.
The follow-up examinations and interviews were performed by urologists who were not involved in the surgical phase of the study. 
The severity of complications was classified using both the ICS/IUGA classification of mesh complications and the modified Clavien–Dindo classification.
Objective cure for SUI was defined as the absence of urine leakage during CST. Subjective cure was defined by a ‘no-answer’ to question 3 of the UDI-6 questionnaire.
We considered PGI-I scores to indicate satisfaction when patients reported either ‘very much better’ or ‘much better’ (score of ≤ 2).
Institutional Review Board Committees approved this study. All participants gave informed consent.
A preliminary power analysis indicated that a sample size of 20 patients per group at P <.05 would have 80% power to reject the null hypothesis that TVT and TOT are not equivalent. Power calculation was performed using PS: Power and Sample Size ver.3.0, 2009 (http://pspower-and-sample-size-calculation.
software.informer.com/). The Mann-Whitney and Wilcoxon tests for unpaired and paired data, respectively, were used to compare ordinal and nonnormally distributed continuous variables. Categorical data were analyzed by the McNemar, chi-square, or Fisher exact test. Two-tailed P <.05 was considered
significant. All calculations were performed with IBM SPSS, version 22.0.

From September 2017 to December 2019, 47 consecutive women aged over 75 with SUI or prevalent stress MUI were enrolled. Four out of the 47 patients were not included: 3 did not meet all inclusion criteria and 1 refused to give consent. Forty-three patients were included in the analysis (Figure 1). Among these, 21 patients underwent TVT and the other 22 underwent ‘out-in’ TOT. The mean age of our sample was 77.67+2.82; median parity was 2; mean BMI was 27.54+3.10. 
No intra-operative complications occurred. 
Pre and post-operative symptoms are reported in Table 1. 
At 24 months follow-up, the objective cure rate was 76.7% (85.7% in TVT group and 68,2% in TOT group).
The subjective cure rate was 83.7% (90.5% in TVT group and 81.8% in TOT group). 
We had de novo UUI in 1 patient of TOT group and de novo dry OAB in 8 patients (18.6%) of which 5 in TVT group and 3 in TOT group. No case of de novo voiding symptoms was observed. Mesh extrusion was observed only in 1 patient (TVT group), who was treated with local therapy for three weeks with a complete resolution. QoL was significantly improved in all domains in both groups.
PGI-I scores showed patient satisfaction in 90.5% in TVT group (19 patients) and 90.9% in TOT group (20 patients). The other 2 patients in each group reported an improvement of ‘a little better’. No patients reported ‘no change’ or worse

SUI cure rates were satisfactory and were superior in the TVT group. Correction of UUI in both groups was good. 
We had a high number of de novo dry OAB: 2 of these had no pre-op OAB symptoms and the other 6 had pre-op wet OAB. As OAB symptoms are more common at advanced age, we hypothesise that their continuation in these 6 patients is attributable to their age. This indicates that MUS is a good solution for treating incontinence in women over 75 but is less effective in resolving their OAB symptoms.

This study demonstrates that both MUS procedures are safe and efficient choices for stress-incontinent women over 75. Even if objective results are less good than those in literature for younger women, patient satisfaction is comparable, perhaps because older women have less active lifestyles or lower expectations from their surgery.

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