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.

Randomized controlled trial comparing single-incision mini-sling and transobturator midurethral sling for the treatment of stress urinary incontinence: 3-year follow-up results.

BACKGROUND: The role of single-incision mini-slings (SIMS) in stress urinary incontinence (SUI) management is still not elucidated. OBJECTIVE: To compare efficacy and safety of SIMS and transobturator sling (TOT) for SUI after 36-month follow-up. METHODS: A randomized controlled clinical trial involving 130 women with SUI that had either SIMS or TOT. Primary outcomes: objective cure defined as negative cough stress and pad tests, and subjective cure reported as satisfaction and no desire for additional treatment. SECONDARY OUTCOMES: quality-of-life by IQOL and UDI-6 questionnaires, complications and reoperation rates. Student's t, χ2 , Fisher's exact, and Mann-Whitney tests, ANOVA and P < 0.05 as cut-off point were used for statistics. RESULTS: A total of 82 patients (n:41 each arm) completed 36-month follow-up. Objective cure was lower in the SIMS compared to TOT groups by both per protocol (68.3% and 90.2%, respectively, P = 0.027) and intention-to-treat analysis considering missing data as failures (40.6% and 60.7%, respectively, P = 0.035), while similar in both groups (81.2% and 93.4%, respectively) considering missing data as successes. Subjective cure rates were similar for both groups. TOT group presented better outcome regarding the avoidance and limiting behavior domain of IQOL (P = 0.021), and UDI-6 scores (P = 0.026). Seven out of 69 (10.1%) women in the SIMS group compared with two out of 61 (3.3%) in the TOT group (P = 0.172) had repeat surgery due to recurrent SUI at year follow up. CONCLUSION: TOT was associated to higher objective cure rate than SIMS for SUI treatment although satisfaction rate was similar for both groups 3 years postoperative.

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.

FIGO recommendations: Use of midurethral slings for the treatment of stress urinary incontinence.

BACKGROUND: Stress urinary incontinence (SUI) is a global problem. It can significantly adversely impact a woman's quality of life. The use of synthetic mesh in vaginal surgery is controversial, especially when used for pelvic organ prolapse surgery. Although negative effects have been reported, the synthetic mesh midurethral sling (MUS) is considered to be safe and effective in the surgical treatment of SUI. OBJECTIVES: To provide evidence-based data and recommendations for the obstetrician/gynecologist who treats women with SUI and performs or plans to perform MUS procedures. METHODS: Academic searches of MEDLINE, the Cochrane Library, Embase, and Google Scholar articles published between 1987 and March 2020 were performed by a subgroup of the Urogynecology and Pelvic Floor Committee, International Federation of Gynecology and Obstetrics (FIGO). SELECTION CRITERIA: The obtained scientific data were associated with a level of evidence according to the Oxford University Centre for Evidence-Based Medicine and GRADE Working Group system. In the absence of concrete scientific evidence, the recommendations were made via professional consensus. RESULTS: The FIGO Urogynecology and Pelvic Floor Committee reviewed the literature and prepared this evidence-based recommendations document for the use of MUS for women with SUI. CONCLUSIONS: Despite the extensive literature, there is a lack of consensus in the optimal surgical treatment of SUI. These recommendations provide a direction for surgeons to make appropriate decisions regarding management of SUI. The MUS is considered safe and effective in the treatment of SUI, based on many high-quality scientific publications and professional society recommendations. Comprehensive long-term data and systemic reviews are still needed, and these data will become increasingly important as women live longer. These recommendations will be continuously updated through future literature reviews.

COVID-19: A Challenge to the Safety of Assisted Reproduction.

There is an increased risk of becoming pregnant through fertility treatments using assisted reproductive technology (ART) during the COVID-19 pandemic. The aim of this review is to gather comprehensive data from the existing literature on the potential risks of fertility management during the pandemic period, and outline strategies to mitigate them, with a focus on the hormonal and surgical procedures of ART. A comprehensive search of the scientific literature on COVID-19 in relation to fertility was conducted in the PubMed database using the keywords "coronavirus," "COVID-19," "SARS-CoV-2" and "pregnancy," "fertility," "urogenital system," "vertical transmission," "assisted human reproduction," "controlled ovarian stimulation," "oocyte retrieval," "in vitro fertilization," "hormones," "surgical procedures," "embryos," "oocytes," "sperm," "semen," "ovary," "testis," "ACE-2 receptor," "immunology," "cytokine storm," and "coagulation," from January 2020-July 2022. Published data on pregnancy and COVID-19, and the interaction of the urogenital system and SARS-CoV-2 is reported. The immunologic and prothrombotic profiles of patients with COVID-19, and their increased risks from controlled ovarian stimulation (COS) and ART surgeries, and how these procedures could facilitate COVID-19 and/or contribute to the severity of the disease by enhancing the cytokine storm are summarized. Strategies to prevent complications during COS that could increase the risks of the disease in pre-symptomatic patients are considered. The impact of SARS-CoV-2 on pre-symptomatic infertile patients presents a challenge to find ways to avoid the increased hormonal, immunologic, and prothrombotic risks presented by the use of COS in ART protocols during the COVID-19 outbreak. Safe ART procedures and recommendations are highlighted.

Influence of estrogen replacement and aging on the expression of nerve growth factor in the urethra of female rats.

OBJECTIVE: To evaluate the expression of nerve growth factor (NGF) in the urethra of adult female rats in different hormonal status using immunohistochemical assay. METHODS: Forty-eight rats (Rattus norvegicus albinus, Rodentia, Mammalia) from the CEDEME-UNIFESP laboratory animal facility were used in the study. Rats were divided into four groups: group A, 12 non-neutered rats; group B, 12 oophorectomized rats; group C, 12 castrated rats treated with 17ß-estradiol for 30 days; and group D, 12 aging rats. Animals were killed by lethal injection and their urethra was removed. NGF expression was evaluated by means of immunohistochemistry using mouse monoclonal primary IgG antibody anti-NGF diluted 1:600, and read under 400× magnification. Digital analysis of the images was done by Imagelab software. The intensity of the dark brown color was used as a measure of NGF cytoplasmatic expression, and was used to quantify the percentage of epithelial and muscular layer cells showing this neurotrophin. RESULTS: After oophorectomy, rats showed a significant increase in NGF expression in the periurethral muscular layer. Compared with oophorectomized rats, NGF expression increased in the epithelial layer and diminished in the periurethral smooth muscle following estrogen administration. In 18-month-old rats, NGF expression was diminished in both epithelial and muscular layers. CONCLUSIONS: Hormonal status led to significant differences in NGF protein expression in urethral epithelium and periurethral smooth muscle.

The Manchester-Fothergill technique: Browsing in the cutting-edge art gallery.

BACKGROUND: No consensus regarding the surgical strategy for repairs of pelvic organ prolapse (POP) has existed since the writings of Hippocrates. Archibald Donald of Manchester, in 1888, quite independently began to treat cases of prolapsus uteri with a combined operation of anterior and posterior colporrhaphy and amputation of the cervix. OBJECTIVE: To describe the surgical technique of Manchester-Fothergill and to chart its history. SEARCH STRATEGY: A bibliographic search was performed of the PubMed and National Library of Medicine (NIH) databases. SELECTION CRITERIA: The terms "Manchester-Fothergill" AND "History" AND "Pelvic Organ Prolapse" were searched from the first publication on this topic (1951) to December 2020. DATA COLLECTION AND ANALYSIS: Data were extracted from studies independently by two authors. All types of relevant abstracts were selected and analyzed due to the scarcity of studies (books and documents, clinical trials, meta-analysis, randomized controlled trial, review and systematic review). MAIN RESULTS: Although this is a well-described procedure in historic texts, the practical application is not often employed, and modern surgical texts rarely describe how to perform this surgery. The advantages of the Manchester-Fothergill technique include maintenance of the pelvic anatomy, integrity, a reduction of intraoperative blood loss, and shortened operation times and hospital stays. CONCLUSION: Many young gynecologists are not familiar with this operation; therefore, it is important to provide training and exposure to the Manchester-Fothergill technique in the practice of gynecological surgery.

Treatment for vaginal agenesis: A prospective and comparative study between vaginal dilation and surgical neovaginoplasty.

OBJECTIVE: To compare, in terms of anatomical, functional, and sexual aspects, two types of treatment for women with vaginal agenesis: progressive dilation or surgical neovaginoplasty. METHODS: Women with vaginal agenesis underwent either dilation treatment using the Frank method or surgical treatment using the modified Abbé-McIndoe technique with oxidized cellulose. Patients were evaluated 3-6 months after treatment for a follow-up including medical history, physical examination, general satisfaction, clinical aspect of the vagina, Female Sexual Function Index, and three-dimensional pelvic floor ultrasound. RESULTS: In total, 20 women with vaginal agenesis were included in the present study; nine in the dilation group and 11 in the surgical group. A comparison between the groups (vaginal dilation and surgical neovaginoplasty) showed efficacy in neovagina formation after both treatments, with a statistically significant difference between the pre- and post-treatment periods (P value pre- × post-dilation group <0.0001 and P value pre- × post-surgical group <0.0001). There were no statistical differences in total vaginal length measurements (P value post-dilation × post-surgical = 0.09) or Female Sexual Function Index scores (P = 0.72) after both treatments. CONCLUSION: Both treatments had satisfactory efficacy and positive outcomes for patients with vaginal agenesis concerning anatomical, functional, and sexual aspects, with minimum complications in the surgical group. Dilation treatment can remain the first-line therapy.

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.

Vaginoplasty with oxidized cellulose: anatomical, functional and histological evaluation.

OBJECTIVE: To present and evaluate the histological, anatomical and functional results of the McIndoe procedure, as modified by the application of oxidized cellulose (Surgicel™) in women with vaginal agenesis. STUDY DESIGN: Eleven patients with vaginal agenesis underwent vaginoplasty using a mould that had been wrapped with oxidized cellulose. The surgeries were performed between January 2009 and January 2010. Eight of the patients had been diagnosed with Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, and the remaining three had been diagnosed with cervicovaginal agenesis (CVA). The mean follow-up time was 14 months (range, 6-24 months), and it included clinical examinations and evaluation of the Female Sexual Function Index (FSFI). Neovaginal biopsies were taken at the time of surgery and 1-12 months after surgery. The histology of the samples was evaluated to determine squamous epithelialization of the neovaginal tissue over time, and the total collagen content of the neovaginas were compared with normal control subjects. For statistical analysis we employed the ANOVA test and the t-test. RESULTS: At 6 months, anatomical success was achieved in 100% of the MRKH syndrome patients (neovaginal length ≥ 6 cm), and functional success was achieved in 100% of the patients who started their sexual life (FSFI score ≥ 30). Biopsy results showed complete epithelialization of the neovagina after 5 months in all samples, and the collagen content was comparable to that of a normal vagina. One major postoperative complication occurred in a patient with CVA, which culminated in death. The uterovaginal canalization procedure was unsuccessful at creating an outflow tract for regular menses in all cases. CONCLUSIONS: The procedure described here offers patients a functional vagina by means of a simple and low-cost procedure that elicits squamous epithelialization of the neovaginal vault, with total collagen content similar to that of normal vaginal tissue. It is a potential alternative therapeutic approach for MRKH syndrome but not applicable to cases of CVA.

Isoflavone regulates vascular endothelial growth factor expression in urinary tract of castrated rats.

OBJECTIVE: The purpose of this study was to investigate Vascular Endothelial Growth Factor Expression (VEGF) gene regulation by isoflavone in urinary tract tissues of castrated adult rats. DESIGN: Forty-five adult rats, 90 days old, weighting 200 g were used, receiving a soy-free ration. The animals were castrated for drug administration for 30 days (125 microg genisteine/g body weight/day) and sacrificed, divided into three groups: Group I-control; Group II-started isoflavone administration on the 5th day after castration; Group III-started isoflavone administration on the 28th day after castration. RNA was isolated from each bladder and urethra. Determination of VEGF gene regulated by isoflavone was obtained using a semiquantitative RT-PCR and immunohistochemistry of total RNA isolated from bladder and urethra. RESULTS: Our results demonstrate that isoflavone was able to upregulate mRNA level of the VEGF gene in the lower urinary tract of rats in Group II, where isoflavone administration was started at an early phase of estrogen deprivation, while in Group III, where isoflavone administration was started in the late phase of hypoestrogenism, did not show alteration of bladder and urethra VEGF gene expression, compared to placebo, maintaining the same level of the castrated rats without treatment. CONCLUSIONS: The data indicate that VEGF expression in rats is also regulated by isoflavone in early phase of hypoestrogenism.

Ultrasonographic and doppler velocimetric evaluation of the levator ani muscle according to the hormonal status.

OBJECTIVE: We aimed to study the cross-sectional area of levator ani muscle and the doppler velocimetric parameters of vessels its in premenopausal and postmenopausal women. STUDY DESIGN: Sixty-four patients, divided into 3 groups, were assessed: group I (20 women-average age 28 years) premenopausal and nulliparous (control); group II (24 women-average age 38 years, vaginal delivery 1-4) premenopausal with vaginal deliveries; group III (20 women-average age 55 years, parity 0-4) postmenopausal without hormonal therapy. Doppler velocimetry of levator ani muscle vessels through resistance and pulsatility indices was used and the means of the groups compared by adjusting the weighed variance model with multiple comparisons, according to Tukey's method. Similarly, we measured the cross-sectional area of the muscle using ultrasonography. RESULTS: There was a significant increase in resistance and pulsatility indices in postmenopausal patients as compared to the other two groups. We also observed a significant decrease in the cross-sectional area of the muscle of postmenopausal patients when compared to those in premenopausal. CONCLUSION: The obtained results allow us to conclude that levator ani muscle vascularization significantly decreases after menopause (age and/or hipoestrogenism) and that it can be assumed that vaginal delivery does not promote long-term alterations in levator ani muscle vascularization. We also observed a significant decrease in the cross-sectional area of the muscle in postmenopausal women when compared to those in premenopausal.