Long-term outcomes of transobturator suburethral tapes for female stress urinary incontinence.

AIMS: The aim is to evaluate long-term effectiveness and safety of transobturator midurethral slings (TO-MUS) for treating female stress urinary incontinence (SUI). Possible risk factors for failure and complications are also evaluated. METHODS: A descriptive retrospective study was performed among women with SUI treated at a tertiary urogynecology unit between January 2004 and December 2006. Women with stress-predominant mixed urinary incontinence or with associated pelvic organ prolapse were also included. Postoperative follow-up was performed at 1, 6, and 12 months and yearly thereafter. Outcomes were classified as cured, improved or failed. RESULTS: Of 896 women operated on over the study period, 565 were suitable for the analysis. Of them, 327 women completed the 5-year, 225 the 7-year, and 172 the 10-year follow-up periods. Success rates were 77.6%, 73.8%, and 73.2% at 5, 7, and 10 years, respectively. On multivariate Cox regression models age, body mass index, and previous incontinence surgery were related to failure. Complications of any type were described in 24.9% of patients, although most of them were mild. Only concomitant prolapse surgery was related to intraoperative and peroperative complications and the inside-out route to an increased odds of groin pain (odds ratio = 4.0). CONCLUSIONS: This study showed that TO-MUS is an effective and safe procedure in the long-term. The expected outcomes and possible side effects profile should be discussed in detail during the counseling process before opting for a treatment option.

Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial.

AIMS: To compare the effectiveness and safety of polypropylene (PP) and polyvinylidene fluoride (PVDF) transobturator tapes (TOT) for the treatment of female stress urinary incontinence (SUI). METHODS: This is a multicentre randomized trial. Women with SUI or stress-predominant mixed urinary incontinence and scheduled for a TOT procedure were randomized to PP or PVDF slings. The primary outcome was 1-year cure or improvement rate using composite criteria. Complications were also compared. Relationships with outcomes were analyzed using multivariable logistic regressions models. RESULTS: From April 2016 to January 2018 285 participants were randomized. PP and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%, p = .138). Improvement in validated questionnaires was also similar. PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15-0.80). We found no statistical differences in complications rates, although a higher incidence of long-term pain events were observed in the PP group. The study is underpowered to find differences in specific complications owing to the low number of events. CONCLUSION: PP and PVDF TOTs are equally effective, although PVDF is associated with fewer cases of de novo urgency incontinence. Further studies are needed to give robust conclusions on safety profiles.

Long-term outcomes of retropubic tension-free vaginal tape for stress urinary incontinence after a transobturator tape failure: a retrospective study.

INTRODUCTION AND HYPOTHESIS: Management of stress urinary incontinence (SUI) after a transobturator tape (TOT) failure is a controversial issue. There are few long-term data on the different treatment options. The aim of this study is to evaluate the long-term effectiveness and safety of retropubic suburethral slings (RP-TVT) in this setting. METHODS: A descriptive retrospective study was performed among women with persistent/recurrent SUI treated at the Vall d'Hebron University Hospital between January 2006 and December 2014. All women were preoperatively evaluated to rule out complications of the first sling. Postoperative follow-up was performed at 1, 6 and 12 months and yearly thereafter. Outcomes were classified as cured, improved or failed. RESULTS: Forty-one women were operated on over the study period. The median follow-up time was 103.2 months. Likelihood to be cured or improved at 3, 5, 7 and 10 years was 78.0%, 75.4%, 71.9% and 67.4%, respectively. Absence of urethral hypermobility was the only variable related to RP-TVT failure. Complications during follow-up were observed in 39% of patients, although most of them were mild. However, two cases (4.9%) of vaginal exposure and three (7.3%) of lower urinary tract extrusion were observed. De novo urgency occurred 17.1% of women. CONCLUSIONS: RP-TVT showed reasonable long-term effectiveness but had a high overall complication rate in the treatment of persistent/recurrent SUI after TOT. Expected outcomes and possible side effects should be discussed in detail during counseling before opting for a treatment option.

External validation of de novo stress urinary incontinence prediction model after vaginal prolapse surgery.

INTRODUCTION AND HYPOTHESIS: Stress urinary incontinence (SUI) may appear after the correction of pelvic organ prolapse (POP). The aim of this study was to externally validate a described predictive model for de novo SUI and to assess its clinical performance when used as a diagnostic test. METHODS: This was a retrospective descriptive study on a cohort of consecutive women treated in our institution. The main outcome used to validate the model was the presence of objective or subjective SUI 1 year after surgery. A receiver operating characteristic curve was generated from our population to evaluate the predictive accuracy and to compare it with the original model. A cutoff point of ≥50% was used to evaluate its clinical performance as a diagnostic test. RESULTS: Of the full cohort, 169 women were suitable for analysis. The rate of de novo SUI was 11.8%. The predictive accuracy of the model in our population was similar to the original [area under the curve (AUC) = 0.69; 95% confidence interval (CI) = 0.58-0.80). However, its performance measures when evaluated as a diagnostic test were low: positive likelihood ratio = 2.71 and negative likelihood ratio = 0.86. Only 15 women presented a positive test result. CONCLUSIONS: External validation of the model found a global predictive accuracy similar to that of the original model. Despite the study being underpowered to give firm conclusions, the test did not show a good clinical performance when applied to our population with low de novo SUI prevalence. A larger sample size is needed to validate the model conclusively.

Radical Hysterectomy: Efficacy and Safety in the Dawn of Minimally Invasive Techniques.

STUDY OBJECTIVE: To analyze the effect that the introduction of minimally invasive procedures has had on surgical and oncologic outcomes when compared with conventional open radical hysterectomy (ORH) in a national reference cancer after 17 years of experience in radical hysterectomy. DESIGN: A prospective controlled study (Canadian Task Force classification II-2). SETTING: A university teaching hospital. PATIENTS: All patients who underwent radical hysterectomy as primary treatment for cervical cancer in our institution between May 1999 and June 2016, with a total of 188 patients. INTERVENTIONS: Patients underwent ORH or minimally invasive surgery (MIS) (i.e., laparoscopic or robotically assisted radical hysterectomy). MEASUREMENTS AND MAIN RESULTS: Seventy-six patients underwent ORH, 90 laparoscopic radical hysterectomy, and 22 robotically assisted radical hysterectomy. Blood loss and hospital stay were inferior in the MIS group (p <.0001). The laparotomic group presented shorter operation times (p = .0001). With a median follow-up of 112.4 months, a total of 156 patients (83%) were alive and free of disease at the time of the data analysis. Overall survival was higher in the MIS group when compared with the ORH group (91 vs 78.9, p = .026). There were no differences regarding recurrence rates between the surgical approaches. CONCLUSION: With 1 of the largest follow-up periods in the literature, this study provides added evidence that MIS could become the preferable surgical approach for early-stage cervical cancer since it appears to reduce morbidity without affecting oncologic results.

Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling.

INTRODUCTION AND HYPOTHESIS: Tension-free suburethral tapes have become the first-line surgical treatment for female stress urinary incontinence. Single-incision midurethral slings (SIMS) were introduced with the aim of offering similar efficacy with reduced morbidity, particularly postoperative pain. The objective of this study was to compare the effectiveness and complications of the Ajust™ SIMS and the Align™ transobturator tape sling. METHODS: We performed a randomized controlled trial with a noninferiority design. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. The primary outcome was the cure/improvement rate at 1 year, defined according to combined objective and subjective criteria. Rate differences for cure/improvement with the two procedures were calculated along with their 95% confidence intervals. The Sandvik incontinence severity index and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were completed before surgery and at 1 year. Complications were also reported. RESULTS: We randomized 30 women to the Ajust™ group and 28 to the Align™ group. At 1 year the cure/improvement rates were 93.3% in the Ajust™ group and 96.4% in the Align™ group. The rate difference for cure/improvement was of -3.1% (95% CI -14.4 % to 8.2%). The study was sufficiently powered to conclude the noninferiority of Ajust™ SIMS under the pre-established criteria. Three women in the Ajust™ group reported persistent thigh pain 1 year after surgery, but none in the Align™ group reported pain. CONCLUSIONS: At 1 year, the Ajust™ SIMS showed non-inferior effectiveness compared with the Align™ transobturator sling. Although not statistically significant, unexpectedly, more women reported persistent thigh pain in the Ajust™ group.

Comparative study of polyvinylidene fluoride and polypropylene suburethral slings in the treatment of female stress urinary incontinence.

Aims Evaluate the effectiveness and safety of polyvinylidene fluoride (PVDF) transobturator suburethral slings/tapes (TOTs) in the treatment of stress urinary incontinence, and compare them to polypropylene (PP) slings. Material and Methods A retrospective cohort study was performed on women treated with a TOT procedure at Vall d'Hebron Hospital between February 2010 and May 2013. A PVDF sling was used in surgeries on 23 women. A comparison group was randomly selected among all women treated with a PP sling in a 1:4 ratio (n = 92). Failure incidence was analyzed by Kaplan-Meier survival functions and a multivariate Cox regression model. Results Both groups were similar in their initial characteristics. The median follow-up was 24.6 months in the PP group and 21.3 months in the PVDF group. The survival functions showed a higher incidence of failures in the PP group, primarily because of obstructive symptoms. However, the differences were not statistically significant (hazard ratio of failure of PP vs PVDF 4.31; 95% confidence interval 0.56-33.05). Complication rates did not differ between the two groups. More cases of voiding dysfunction were observed in the PP group. Conclusions Polyvinylidene fluoride suburethral tapes have been found to have an effectiveness and safety comparable to PP tapes.

The surgical management of early-stage cervical cancer.

PURPOSE OF REVIEW: The main objective is to update the literature data in the last year which may support a surgical approach to early cervical cancer [ECC; Stage International Federation of Gynecology and Obstetrics (FIGO) IA-IB1-IIA1]. Radical hysterectomy remains the gold standard by most international guidelines because surgical treatment has hardly changed in recent decades, except for stage IA1. RECENT FINDINGS: Trends in clinical research in the past 12-18 months involve minimal invasive surgery (with laparoscopic surgery or robotic-assisted surgery), fertility preservation (in the initial stages and in the absence of bad prognostic factors), nerve-sparing and sentinel node techniques. Some institutions have published studies in specific groups such as older, obese or pregnant women. SUMMARY: There is a growing trend to practice less aggressive surgery in order to preserve fertility in young women and avoid an excess of treatment in some selected patients. Therefore, nerve-sparing techniques can help to improve the quality of life. More studies are needed to demonstrate oncologic results of the sentinel node technique. Laparoscopic and robotic-assisted surgery can substitute open surgical treatment.

Laparoscopic radical hysterectomy with pelvic lymphadenectomy in early invasive cervical cancer.

Laparoscopic radical hysterectomy is one surgical procedure currently performed to treat gynecologic cancer. The objective of this review was to update the current knowledge of laparoscopic radical hysterectomy in early invasive cervical cancer. Articles indexed in the MEDLINE database using the key words "Laparoscopic radical hysterectomy" and "Cancer of the cervix" were reviewed. Studies of laparoscopic radical hysterectomy for treatment of early cervical cancer with a minimum study population of 10 patients were selected. The laparoscopic approach was associated with less surgical morbidity (surgical bleeding) and with shorter length of hospital stay, although the duration of the operation may be longer. Laparoscopic radical hysterectomy with endoscopic pelvic lymphadenectomy, and paraaortic lymphadenectomy if needed, is a safe surgical option for treatment and staging of early invasive cervical cancer considering surgical risk, intraoperative bleeding, intraoperative and postoperative complications, and patient recovery. It is important to respect the learning curve. Surgical advances including new laparoscopic instrumentation and, in particular, use of robotics will contribute to reducing the duration of the operation and to facilitating learning and teaching of the procedure.

Nerve-sparing versus non-nerve-sparing radical hysterectomy: surgical and long-term oncological outcomes.

OBJECTIVES: There are controversies regarding the long-term oncological safety of preservation of pelvic innervation during radical hysterectomy (RH). This study aimed to analyze the feasibility and safety of nerve-sparing radical hysterectomy (NSRH) for cervical cancer compared with non-NSRH following 17 years of experience in a tertiary cancer referral center. MATERIALS AND METHODS: Between May 1999 and June 2016, all patients who underwent RH for cervical cancer were followed-up prospectively. Comparison analyses regarding surgical outcomes, complications, overall survival (OS), disease-free survival (DFS), and cancer-specific survival (CSS) were performed between patients treated with NSRH and non-NSRH. RESULTS: A total of 188 patients were included (113 non-NSRH and 75 NSRH). The median follow-up was 112 months. Estimated blood loss and hospital stay were all significantly lower in the NSRH group. Overall intraoperative complication rate (p = 0.02) and need for transfusion (p = 0.016) were lower in the NSRH group. There were no differences in the median operation time, OS, DFS, CSS, or recurrence rates between the NSRH and non-NSRH group. CONCLUSIONS: Our study provides a wide perspective on the developments of nerve-sparing procedures for the management of women with early-stage cervical cancer. Our results suggest that NSRH is a feasible and safe procedure, with reduced morbidity outcomes.

Contraception, pregnancy and rare respiratory diseases.

Three percent of rare diseases are pneumopathies. Improvements in survival and quality of life have led to a new situation where patients with rare respiratory diseases want to plan their reproductive lives. The intention of this review is to present the experience accumulated in the field of the reproductive health of these women. In several rare respiratory diseases, a genetic base has been identified. The combination of preimplantation genetic diagnosis, assisted reproduction and molecular biology techniques enable embryos to be studied genetically before being transplanted into the uterus. Therefore, the risk for transmitting a certain disease or chromosome alteration may be avoided in high-risk couples, and prenatal diagnoses may be done by chorionic villus sampling or amniocentesis. As a general rule, contraceptive methods should be personalized by evaluating the general state of female patients as well as their possibilities for pregnancy, complications and the future possibility of lung transplantation. In lymphangioleiomyomatosis and primary pulmonary hypertension, pregnancy is considered a contraindication. In the former, there is a very high risk for pneumothorax and loss of lung function. In the latter, mortality reaches 33%. In cystic fibrosis, it is estimated that each year 4% of patients become pregnant and there is no observed loss in lung function. There are special circumstances in childbirth that should be considered as well as specific anesthesia risks. The present review suggests that the decision about contraceptive methods, pregnancy as a contraindication or conditions for managing a pregnancy should be both individualized and multidisciplinary.

Cyclo-oxygenase type 2 is dysregulated in breast ductal carcinoma in situ and correlates with poor outcome.

OBJECTIVE: Clinico-pathologic data on microinvasive carcinoma of the breast (MICB) as defined by the 2003 TNM criteria (T1mic