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.

Fertility-Sparing Approaches in Atypical Endometrial Hyperplasia and Endometrial Cancer Patients: Current Evidence and Future Directions.

Endometrial cancer (EC) is the fourth most common cancer in women in developed countries. Although it is usually diagnosed in postmenopausal women, its incidence has increased in young women, as well in recent decades, with an estimated rate of 4% in those under 40 years of age. Factors involved in this increase, particularly in resource-rich countries, include delayed childbearing and the rise in obesity. The new molecular classification of EC should help to personalize treatment, through appropriate candidate selection. With the currently available evidence, the use of oral progestin either alone or in combination with other drugs such as metformin, levonorgestrel-releasing intrauterine devices and hysteroscopic resection, seems to be feasible and safe in women with early-stage EC limited to the endometrium. However, there is a lack of high-quality evidence of the efficacy and safety of conservative management in EC. Randomized clinical trials in younger women and obese patients are currently underway.

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.

Surgical approaches in women with endometrial cancer with a body mass index greater than 35 kg/m2.

AIM: Endometrial cancer is often associated with obesity. We want to compare the outcomes of surgical staging according to the surgical approach in patients with a body mass index ≥35 kg/m2 . METHODS: A retrospective cohort study with 138 patients with endometrial cancer and body mass index ≥35 kg/m2 with different surgical staging routes: laparotomy (LPT; n = 94) and minimally invasive surgery (MIS): laparoscopy (LPC; n = 18) + robotic assisted laparoscopy (n = 26). RESULTS: Lymphadenectomy rate was similar in the three groups; there were no differences in the number of nodes removed. Decreased bleeding (P = 0.002) and hospital admission length (P < 0.001) was observed in the endoscopic group. Less early-postoperative complications were observed in the robotic approach (P = 0.007). Significant differences were not observed in recurrence-free survival or in overall survival. CONCLUSION: Minimal invasive surgical staging in obese women with endometrial cancer could represent the surgical route of choice because it decreases operative bleeding, hospital admission length and the early postoperative complication rate without compromising recurrence-free survival or overall survival.

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.

Effect of Functionalization of Texturized Polypropylene Surface by Silanization and HBII-RGD Attachment on Response of Primary Abdominal and Vaginal Fibroblasts.

Soft tissue defects, such as incisional hernia or pelvic organ prolapse, are prevalent pathologies characterized by a tissue microenvironment rich in fragile and dysfunctional fibroblasts. Precision medicine could improve their surgical repair, currently based on polymeric materials. Nonetheless, biomaterial-triggered interventions need first a better understanding of the cell-material interfaces that truly consider the patients' biology. Few tools are available to study the interactions between polymers and dysfunctional soft tissue cells in vitro. Here, we propose polypropylene (PP) as a matrix to create microscale surfaces w/wo functionalization with an HBII-RGD molecule, a fibronectin fragment modified to include an RGD sequence for promoting cell attachment and differentiation. Metal mold surfaces were roughened by shot blasting with aluminum oxide, and polypropylene plates were obtained by injection molding. HBII-RGD was covalently attached by silanization. As a proof of concept, primary abdominal and vaginal wall fasciae fibroblasts from control patients were grown on the new surfaces. Tissue-specific significant differences in cell morphology, early adhesion and cytoskeletal structure were observed. Roughness and biofunctionalization parameters exerted unique and combinatorial effects that need further investigation. We conclude that the proposed model is effective and provides a new framework to inform the design of smart materials for the treatment of clinically compromised tissues.

Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure.

INTRODUCTION AND HYPOTHESIS: This study was conducted to evaluate the effectiveness and safety of retropubic suburethral slings (TVT) to treat recurrent stress urinary incontinence (SUI) after transobturator tape (TOT) failure. METHODS: A descriptive study was performed among women with recurrent SUI treated at the Vall d'Hebron University Hospital between January 2006 and December 2009. All women were preoperatively evaluated to rule out complications of the first sling. Urodynamic testing was performed before and after the TOT procedure in all cases. Postoperative follow-up was performed at 1, 6, and 12 months and yearly thereafter. Outcomes were classified as cured, improved, or failed. RESULTS: Twenty-three women were operated on over the study period. The median time to reoperation was 12 months (range 6 to 34 months) and the median follow-up time was 36.1 months (range 7.8 to 60.2 months). Overall cure and improvement rates were 86.4% at 12 and 24 months and 75% at 36 months. Failure was found not to be related to time between both sling surgeries. Two cases of bladder perforation were recorded (8.7%). Postoperative complications were slight and self-limited. De novo urgency occurred in five cases (21.7%). CONCLUSIONS: TVT has been found to be effective to treat recurrent SUI after TOT failure in the present series with slight side effects.

Fertility-Sparing Treatment for Atypical Endometrial Hyperplasia and Endometrial Cancer: A Cochrane Systematic Review Protocol.

INTRODUCTION: Endometrial cancer is the fifth most common cancer in women and atypical endometrial hyperplasia is a precancerous lesion. Obesity is an important risk factor for endometrioid endometrial adenocarcinoma and endometrial hyperplasia. Progesterone is recommended as first-line treatment in endometrial cancer or atypical endometrial hyperplasia in women who wish to preserve fertility, but optimal treatment schedules have not been defined. Metformin or bariatric surgery may also be useful in these women. The effectiveness and safety of fertility-preserving treatments being used for women with atypical endometrial hyperplasia and stage IA grade 1 endometrial cancer is unclear. Therefore, the systematic review aims to determine this point. METHODS: We will search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registers, conference proceedings, abstracts, cooperative trial groups and reference lists. We will include randomised controlled trials (RCTs) that compare fertility-preserving therapy including orally administered progesterone versus a levonorgestrel-releasing intrauterine system (IUS), metformin, other pharmacological interventions or bariatric surgery, and any of these interventions with womb-removing surgery. Quasi-randomised trials, non-randomised trials and cohort studies will be included. Two review authors will independently assess study eligibility and risk of bias and extract data. The primary outcomes are complete pathologic response and live birth rate. Secondary outcomes include overall survival, progression-free survival, pregnancy rate, need for hysterectomy, adverse events, psychological symptoms and quality of life. PLANNED OUTCOMES: This review aims to clarify the effectiveness and risks of fertility-preserving treatments, including complete pathologic response rate, live birth rates, need for surgical treatment, adverse events, psychological symptoms and quality of life. The broad scope of the review includes the use of progesterone, metformin to reverse insulin resistance, and bariatric surgery or operative hysteroscopy. RESULTS: The results may help to determine the optimal fertility-sparing treatment in endometrial cancer and atypical endometrial hyperplasia. SYSTEMATIC REVIEW REGISTRATION: Prospero 2019 number CRD42019145991.

Trans-obturator suburethral tape for female stress incontinence: a cohort of 254 women with 1-year to 2-year follow-up.

BACKGROUND: A clinical cohort study of 254 women undergoing trans-obturator surgery for stress urinary incontinence was conducted to assess the efficacy of the trans-obturator suburethral tape (TOT) after a follow-up of 1 year (251 evaluable patients) and 2 years (62 patients). RESULTS: Seventy-five patients had previous gynaecologic surgery. Overall cure and improvement rates were 82% at 6 and 12 months, and 90% at 24 months. The most favourable results were obtained in patients with occult incontinence and urethral hypermobility. The relative risk (RR) for failure in patients with a history of gynaecologic surgery was 3.3 (95% CI: 1.1-14.7). There were 8 cases of bladder perforation (3.1%) during the learning phase with the TOT procedure, 20 of urinary retention (7.9%) - in 1 patient the tape was released after 12 days of insertion - and 3 of tape erosion (1.2%). CONCLUSION: Results are encouraging but should be substantiated on a larger series over a longer follow-up.

Cervical pregnancy complicated with group B streptococcal meningitis.

Maternal group B streptococcal infection is an uncommon entity. Herein we describe a case of a 27-year-old-woman who presented life-threateniing group B streptococcus meningitis with an ectopic cervical pregnancy. No other infectious focus have been found. To our knowledge this is the first time that this association has been reported.

Inherited antithrombin deficiency and pregnancy: maternal and fetal outcomes.

OBJECTIVE: To describe the outcome of pregnancy in women with inherited antithrombin (AT) deficiency. STUDY DESIGN: A descriptive retrospective study was performed. Medical records were reviewed in order to collect data about maternal thrombotic complications and pregnancy outcomes. All women with known inherited AT deficiency and at least one pregnancy looked after at the Vall d'Hebron University Hospital were included. Relatives with known AT deficiency but no pregnancies looked after in our institution were excluded. Eighteen pregnancies were registered among nine AT-deficient women during 1991-2005. This cohort included women without antithrombotic treatment because AT deficiency was not known at the time of their pregnancies. RESULTS: In 12 pregnancies (66.7%) anticoagulant therapy with low-molecular weight heparin was given, while not in the other six (33.3%) because AT deficiency was not known at this time. Three episodes of venous thromboembolism were recorded (16.7%). Among all pregnancies 10 suffered an adverse outcome (55.6%), including miscarriage (11.1%), stillbirth (11.1%), intrauterine growth restriction (33.3%), placental abruption (6.7%), preeclampsia (6.7%) and intrapartum fetal distress (23.1%). No relation between AT activity and pregnancy complications was found. A lower incidence of pregnancy complications was observed among women with antithrombotic treatment. CONCLUSIONS: Inherited antithrombin deficiency is associated with a high risk of venous thromboembolism during pregnancy and the puerperium. We also observed a high incidence of poor pregnancy outcome among AT-deficient women.