Anterior colporrhaphy and sacrospinous hysteropexy in women with pelvic organ prolapse: Urodynamic findings and functional outcomes.

OBJECTIVES: Aim of this study was to evaluate urodynamic effects and functional outcomes after anterior colporrhaphy and bilateral sacrospinous hysteropexy (SSH) in patients with stages II-IV pelvic organ prolapse (POP). STUDY DESIGN: This is a single-centre prospective study. Sixty-two women affected by anterior/central compartment prolapse of stage II-IV u ndergoing anterior colporrhaphy and bilateral SSH were recruited from our pelvic center. The preoperative evaluation included history, clinical examination, uroflowmetry and urodynamic studies (UDS). Six months after surgery, all patients performed UDS, completed the Urogenital Distress Inventory (UDI)-6, the Incontinence Impact Questionnaire (IIQ-7) and the Patient Global Impression of Improvement (PGI-I) questionnaire. RESULTS: Median follow-up study was 11 months (range 6-24). Q max significantly improved compared with baseline (21.1 ± 7.3 vs 12.3 ± 7.1 ml/s; p = 0.005) and the percentage of patients with PVR > 30% of premicturitional bladder volume significantly decreased (33.3% vs 11.1%; p = 0.001). At baseline, 24 (38.7%) women had typical phasic DO. Six months after surgery, DO was detected in only eleven women (17.7%) (p < 0.0001), with no de novo cases. Thirteen (21%) women reported SUI preoperatively which persisted in 5 patients (8.1%) after surgery, with no de novo cases. BOO was observed in only eight (12.9%) patients postoperatively compared with 51 (82.3%) at baseline (p < 0.0001). At last follow up visit, the UDI-6 and IIQ-7 total median scores improved significantly (p < 0.001). CONCLUSIONS: Combination of anterior colporrhaphy and bilateral SSH in women with advanced POP provides good functional outcomes, as demonstrated by the urodynamic findings before and after surgery.

Tension-free vaginal tape-obturator and tension-free vaginal tape-Secur for the treatment of stress urinary incontinence: a 5-year follow-up randomized study.

OBJECTIVE: Single-incision slings were developed to overcome the complications related to retropubic and trans-obturator tapes. TVT-Secur was the first of this kind of devices to be marketed and yielded contrasting results. Aim of this non-inferiority study is to report the 5-year follow-up of a randomized, single-blind, controlled trial comparing TVT-O to TVT-Secur. STUDY DESIGN: Randomized, single blind, controlled study conducted in two tertiary urogynecological centers. 154 patients were allocated to either TVT-O or TVT-Secur and were contacted 5 years after the procedure to undergo urogynecological examination (POP-Q staging, challenge stress test and post-void residual urine evaluation), to complete I-QOL and PGI-I questionnaires, and to score their satisfaction on a 5-point Likert scale. Patients who were not objectively evaluated were interviewed over the telephone. Primary outcome was subjective success defined as being "very much improved" or "much improved" on the PGI-I. RESULTS: 120 patients were evaluated only subjectively (TVT-O: 62; TVT-Secur: 58) and 84 objectively and subjectively (TVT-O: 46; TVT-Secur: 38). Subjective success (79% vs. 63.8%) and objective cure rates (82.6% vs. 68.4%) 5 years after the procedure were lower for TVT-Secur, but not significantly. Recurrent UTIs were reported by 17.8% of women (TVT-O 9, TVT-Secur 6) and two de novo urgency cases (one per group) were observed. Re-operation rate for stress urinary incontinence (SUI) was 20%. CONCLUSIONS: TVT-Secur did not show an inferior subjective success rate in comparison with TVT-O five year after the original procedure, even though displaying a clear trend toward a lower efficacy. Considering that the long-term safety profile is similar between the two procedures, there are no advantages in using TVT-Secur.

Tension-free vaginal tape-O and -Secur for the treatment of stress urinary incontinence: a thirty-six-month follow-up single-blind, double-arm, randomized study.

OBJECTIVE: To compare the efficacy of the inside-out tension-free vaginal tape-obturator (TVT-O) device versus the single-incision TVT-Secur device 36 months after the procedure. METHODS: A single-blind, randomized, parallel-group study on 154 patients with stress urinary incontinence (77 treated with TVT-O and 77 with the TVT-Secur hammock approach). The primary endpoint was the objective cure rate 36 months after the procedure evaluated with the challenge stress test. Secondary endpoints were subjective cure rate (evaluated with bladder diary, quality-of-life questionnaires, and patient-reported outcome tools) and intraoperative and postoperative complications. The primary endpoint was evaluated with a noninferiority study design. RESULTS: Sixty-six patients in the TVT-O group and 64 in the TVT-Secur group concluded the study. Thirty-six months after the procedure, 57/66 patients (86.4%) in the TVT-O and 50/64 (78.1%) in the TVT-Secur groups were objectively cured (noninferiority unilateral u test: p < .05). No differences were observed in the subjective cure and complication rates. CONCLUSIONS: TVT-Secur seems not to be inferior to TVT-O in the surgical treatment of stress urinary incontinence and causes less postoperative pain. The possibility of severe blood loss cannot be ruled out when TVT-Secur is used.

Efficacy of a modified technique for TVT-O positioning: a twelve-month, randomized, single-blind, multicenter, non-inferiority study.

OBJECTIVE: To evaluate the impact of a more limited paraurethral dissection, avoidance of perforating the obturator membrane with scissors or guide, and a more medial trajectory of the trocar in positioning the TVT-O device on stress urinary incontinence cure rates. STUDY DESIGN: One hundred and ten patients were recruited for this randomized, single blind, multicenter, non-inferiority study, with a 1:1 ratio to undergo the traditional (n=55) or the modified (n=55) technique. Preoperatively, patients underwent POP-Q staging, Q-tip test, challenge stress test and urodynamics, and completed the I-QoL, PISQ-12, and PGI-S questionnaires. During the post-operative period, patients attributed a pain VAS score 1, 3, 6, 12 and 24h after the procedure and were followed up at 12 months, undergoing the same baseline evaluations. The primary outcome was the cure rate (absence of urine leaks at the challenge stress test or urodynamic testing) one year after the procedure. The primary outcome was evaluated using a non-inferiority test. RESULTS: No differences were observed in cure rates (traditional technique 92.3% vs. modified technique 88.8% and non-inferiority P<0.05) and in questionnaire scores between the two groups. Post-operative pain was significantly lower in the modified technique group at each time point assessed, with the exception of 12h post-operatively. No differences between the two groups were observed in the number of analgesic vials administered. CONCLUSIONS: The modified technique does not seem to reduce the efficacy of TVT-O, but induces a reduction of post-operative pain.