CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO2 laser and radiofrequency as treatment for SUI. METHODS: One hundred thirty-nine women with SUI were eligible and randomized in a three-arm double-blind randomized controlled trial into radiofrequency (RF), laser (LS) and sham control (SCT) groups, with 3-monthly outpatient treatment sessions. One hundred fourteen women were included, 38 in each group, during a 12-month follow-up. The primary outcomes were: subjective improvement of SUI, evaluated on a Likert scale, and objective cure, which was a composite outcome defined according to negative stress tests, voiding diary and pad test. Questionnaires were also applied. The sample size was calculated to provide 80% power to identify a 20% difference between groups, p < 0.05. RESULTS: Subjective improvement and objective cure of SUI were identified respectively in 72.6% and 45.2% in LS and in 61.7% and 44.7% in RF, both significantly higher than the 30.0% and 14.0% in SCT. Considering only mild cases (pad test < 10 g), objective cure was achieved in 66.7% in LS, 63.6% in RF and 22.2% in SCT. Significant reduction in the number of episodes of urinary incontinence was found according to voiding diaries (p = 0.029) and pad weight (p = 0.021). A significant reduction in urgency and urinary loss during sexual intercourse was observed only with LS and RF. Improvement in quality of life was also verified by the I-QoL and ICIQ-SF in favor of the energy-treated groups. CONCLUSIONS: CO2 laser and radiofrequency are outpatient options for SUI treatment, with no major complications. They had similar results and presented better results than in the sham control group.

Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up / Ultrassonografia tridimensional do assoalho pélvico após 3 anos de correção cirúrgica de incontinência urinária de esforço por sling retropúbico, transobturador, ou de incisão única

Abstract Objective Using three-dimensional ultrasound (3D-US), we aimed to compare the tape position and the angle formed by the sling arms in different techniques of midurethral sling insertion for the surgical treatment of stress urinary incontinence, three years after surgery. In addition, we examined the correlations between the US findings and the clinical late postoperative results. Methods A prospective cross-sectional cohort study of 170 patients who underwent a sling procedure between May 2009 and December 2011 was performed. The final sample, with US images of sufficient quality, included 26 retropubic slings (tension-free vaginal tape, TVT), 42 transobturator slings (tension-free vaginal tape-obturator, TVTO), and 37 single-incision slings (tension-free vaginal tape-Secur, TVT-S). The images (at rest, during the Valsalva maneuver, and during pelvic floor contraction) were analyzed offline by 2 different observers blinded against the surgical and urinary continence status. Group comparisons were performed using the Student t-test, the chi-squared and the Kruskal-Wallis tests, and analyses of variance with Tukey multiple comparisons. Results Differences among the groups were found in themean angle of the tape arms (TVT = 119.94°, TVT-O = 141.93°, TVT-S = 121.06°; p < 0.001) and in the distance between the bladder neck and the tape at rest (TVT = 1.65 cm, TVT-O = 1.93 cm, TVTS = 1.95 cm; p = 0.010). The global objective cure rate was of 87.8% (TVT = 88.5%, TVT-O = 90.5%, TVT-S = 83.8%; p = 0.701). The overall subjective cure rate was of 83.8% (TVT = 88.5%, TVT-O = 88.5% and TVT-S = 78.4%; p = 0.514). The slings were located in the mid-urethra in 85.7% of the patients (TVT = 100%, TVT-O = 73.8%, TVTS = 89.2%; p = 0.001), with a more distal location associated with obesity (distal: 66.7% obese; mid-urethra: 34% obese; p = 0.003). Urgency-related symptoms were observed in 23.8% of the patients (TVT = 30.8%, TVT-O = 21.4%, TVT-S = 21.6%; p = 0.630). Conclusions The angle formed by the arms of the sling tape was more obtuse for the transobturator slings compared with the angles for the retropubic or single-incision slings. Retropubic slings were more frequently located in the mid-urethra compared with the other slings, regardless of obesity. However, the analyzed sonographic measures did not correlate with the urinary symptoms three years after the surgery.

Resumo Objetivo Comparar por meio de ultrassom tridimensional (US-3D) a posição e o ângulo entre os braços da faixa, em diferentes técnicas de inserção de sling de uretra média, para tratamento de incontinência urinária de esforço, 3 anos após a cirurgia, correlacionando os achados ultrassonográficos aos resultados clínicos pós-operatórios. Métodos Este é umestudo de coorte transversal prospectivo de 170 pacientes que se submeteram a um procedimento de sling entremaio de 2009 e dezembro de 2011. Foi possível avaliar as imagens de US em 105 pacientes: 26 com tension-free vaginal tape (TVT), 42 com tension-free vaginal tape-obturator (TVT-O) e 37 com tension-free vaginal tape-Secur (TVT-S). As imagens (em repouso, em manobra de Valsalva e em contração perineal) foram analisadas por dois observadores diferentes, que desconheciam o tipo de sling utilizado na cirurgia, assimcomo as queixas da paciente. A análise estatística foi realizada por meio dos testes t de Student, qui-quadrado, Kruskal-Wallis, e análise de variância com comparações múltiplas de Tukey. Resultados As médias dos ângulos entre os braços da faixa foram: TVT = 119,94°, TVT-O = 141,93°, TVT-S = 121,06° (p < 0,001). As médias das distâncias entre o colo vesical e a faixa, em repouso, foram: TVT = 1,65 cm, TVT-O = 1,93 cm, TVTS = 1,95 cm (p = 0,010). A taxa de cura objetiva dos slings foi de 87,8% (TVT = 88,5%, TVT-O = 90,5% e TVT-S = 83,8%; p = 0,701). A taxa de cura subjetiva foi de 83,8% (TVT = 88,5%, TVT-O = 88,5% e TVT-S = 78,4%; p = 0,514). Os slings estavam na uretra média em 85,7% (TVT = 100%, TVT-O = 73,8% e TVT-S = 89,2%; p = 0,001) dos pacientes, e a localização mais distal foi associada a obesidade (distal: 66,7% obesas; uretra média: 34% obesas; p = 0.003). Os sintomas de urgência foram observados em 23,8% das pacientes (TVT = 30,8%, TVT-O = 21,4%, TVT-S = 21,6%; p = 0,630). Não houve diferenças significativas quando se comparam os achados ultrassonográficos e os grupos de pacientes com sintomas de urgência, cura subjetiva e objetiva. Conclusão O ângulo formado pelos braços da faixa foi mais obtuso noTVT-Oquando comparado com o TVT ou o TVT-S. Os TVTs foram localizados mais frequentemente na uretra média quando comparados com os outros dois grupos, mesmo em pacientes obesas. Entretanto, as medidas ultrassonográficas não tiveram correlação com os sintomas urinários três anos após a cirurgia.

Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up.

Objective Using three-dimensional ultrasound (3D-US), we aimed to compare the tape position and the angle formed by the sling arms in different techniques of mid-urethral sling insertion for the surgical treatment of stress urinary incontinence, three years after surgery. In addition, we examined the correlations between the US findings and the clinical late postoperative results. Methods A prospective cross-sectional cohort study of 170 patients who underwent a sling procedure between May 2009 and December 2011 was performed. The final sample, with US images of sufficient quality, included 26 retropubic slings (tension-free vaginal tape, TVT), 42 transobturator slings (tension-free vaginal tape-obturator, TVT-O), and 37 single-incision slings (tension-free vaginal tape-Secur, TVT-S). The images (at rest, during the Valsalva maneuver, and during pelvic floor contraction) were analyzed offline by 2 different observers blinded against the surgical and urinary continence status. Group comparisons were performed using the Student t-test, the chi-squared and the Kruskal-Wallis tests, and analyses of variance with Tukey multiple comparisons. Results Differences among the groups were found in the mean angle of the tape arms (TVT = 119.94°, TVT-O = 141.93°, TVT-S = 121.06°; p < 0.001) and in the distance between the bladder neck and the tape at rest (TVT = 1.65 cm, TVT-O = 1.93 cm, TVT-S = 1.95 cm; p = 0.010). The global objective cure rate was of 87.8% (TVT = 88.5%, TVT-O = 90.5%, TVT-S = 83.8%; p = 0.701). The overall subjective cure rate was of 83.8% (TVT = 88.5%, TVT-O = 88.5% and TVT-S = 78.4%; p = 0.514). The slings were located in the mid-urethra in 85.7% of the patients (TVT = 100%, TVT-O = 73.8%, TVT-S = 89.2%; p = 0.001), with a more distal location associated with obesity (distal: 66.7% obese; mid-urethra: 34% obese; p = 0.003). Urgency-related symptoms were observed in 23.8% of the patients (TVT = 30.8%, TVT-O = 21.4%, TVT-S = 21.6%; p = 0.630). Conclusions The angle formed by the arms of the sling tape was more obtuse for the transobturator slings compared with the angles for the retropubic or single-incision slings. Retropubic slings were more frequently located in the mid-urethra compared with the other slings, regardless of obesity. However, the analyzed sonographic measures did not correlate with the urinary symptoms three years after the surgery.

Objetivo Comparar por meio de ultrassom tridimensional (US-3D) a posição e o ângulo entre os braços da faixa, em diferentes técnicas de inserção de sling de uretra média, para tratamento de incontinência urinária de esforço, 3 anos após a cirurgia, correlacionando os achados ultrassonográficos aos resultados clínicos pós-operatórios. Métodos Este é um estudo de coorte transversal prospectivo de 170 pacientes que se submeteram a um procedimento de sling entre maio de 2009 e dezembro de 2011. Foi possível avaliar as imagens de US em 105 pacientes: 26 com tension-free vaginal tape (TVT), 42 com tension-free vaginal tape-obturator (TVT-O) e 37 com tension-free vaginal tape-Secur (TVT-S). As imagens (em repouso, em manobra de Valsalva e em contração perineal) foram analisadas por dois observadores diferentes, que desconheciam o tipo de sling utilizado na cirurgia, assim como as queixas da paciente. A análise estatística foi realizada por meio dos testes t de Student, qui-quadrado, Kruskal-Wallis, e análise de variância com comparações múltiplas de Tukey. Resultados As médias dos ângulos entre os braços da faixa foram: TVT = 119,94°, TVT-O = 141,93°, TVT-S = 121,06° (p < 0,001). As médias das distâncias entre o colo vesical e a faixa, em repouso, foram: TVT = 1,65 cm, TVT-O = 1,93 cm, TVT-S = 1,95 cm (p = 0,010). A taxa de cura objetiva dos slings foi de 87,8% (TVT = 88,5%, TVT-O = 90,5% e TVT-S = 83,8%; p = 0,701). A taxa de cura subjetiva foi de 83,8% (TVT = 88,5%, TVT-O = 88,5% e TVT-S = 78,4%; p = 0,514). Os slings estavam na uretra média em 85,7% (TVT = 100%, TVT-O = 73,8% e TVT-S = 89,2%; p = 0,001) dos pacientes, e a localização mais distal foi associada a obesidade (distal: 66,7% obesas; uretra média: 34% obesas; p = 0.003). Os sintomas de urgência foram observados em 23,8% das pacientes (TVT = 30,8%, TVT-O = 21,4%, TVT-S = 21,6%; p = 0,630). Não houve diferenças significativas quando se comparam os achados ultrassonográficos e os grupos de pacientes com sintomas de urgência, cura subjetiva e objetiva. Conclusão O ângulo formado pelos braços da faixa foi mais obtuso no TVT-O quando comparado com o TVT ou o TVT-S. Os TVTs foram localizados mais frequentemente na uretra média quando comparados com os outros dois grupos, mesmo em pacientes obesas. Entretanto, as medidas ultrassonográficas não tiveram correlação com os sintomas urinários três anos após a cirurgia.

Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results.

INTRODUCTION AND HYPOTHESIS: The aim was to compare the efficacy and safety of single-incision sling TVT-Secur (TVT-S) and transobturator midurethral sling (TVT-O) for the treatment of stress urinary incontinence (SUI) over 2 years' follow-up. METHODS: This is a randomized controlled trial in which women with SUI were randomly assigned to have either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria included: voiding dysfunction, detrusor overactivity, and pelvic organ prolapse beyond the hymen. The primary outcomes were objective and subjective cure rates at a follow-up visit at 24 months, defined as a negative stress test and pad test as well as absence of self-reported SUI symptoms. Secondary endpoints included quality of life assessment using the King's Health Questionnaire (KHQ), and complication and reoperation rates. Analysis was performed using intention to treat, and statistical significance was fixed at 5% (p < 0.05). Statistical methods used were Mann-Whitney, Student's t, Chi-squared, Fisher's, ANOVA, and McNemar's tests. RESULTS: The groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 77.3% and 83.6%, while subjective cure rates were 75.7% and 80.3% respectively, with no statistically significant differences between the techniques. There was a significant improvement in all KHQ domains in both groups (p < 0.001). A few complications were observed in our study. The most common perioperative complication was thigh pain associated with TVT-O, while the long-term one was tape exposure observed in 5.3% of TVT-O and in 7.5% of TVT-S cases. CONCLUSION: The efficacy of the TVT-S was similar to that of the TVT-O after 2 years' assessment. This cohort will continue to be followed in order to maintain commitment to contributing data on long-term results.

Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). METHODS: This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King's Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p < 0.05). RESULTS: Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) -15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI -11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p < 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p < 0.001). CONCLUSION: TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.