A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Studies have observed a significant heterogeneity in efficacy data for single-incision minislings (SIMS) as surgical treatment for female urinary incontinence (UI). Our study aim was to test the hypothesis that different vaginal kits for SIMS have different long-term outcomes. METHODS: One hundred and twenty women with stress (SUI) or mixed (MUI) UI were enrolled in a multicenter randomized clinical trial (registration number NCT00751088) and treated with three different SIMS (Ajust, MiniArc, or TVT Secur System). Duration of follow-up was at least 24 months from surgery. The primary outcome was the subjective cure rate at 24 months from surgery; secondary outcomes were rates of total failure and reoperations for UI. RESULTS: At study end, no difference was detected between groups in terms of total subjective cure rate [21 (52.5%) vs. 26 (65.0%) vs. 21 (52.5%), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.412] or in terms of total failure rate [24 (60.0%) vs. 22 (55.0 %) vs. 27 (67.5 %), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.432]. The proportion of patients who received a second surgery for UI was also not significantly different between groups [13 (32.5%) vs. 10 (25.0%) vs. 13 (32.5%), in Ajust, MiniArc, and TVT Secur System, respectively; P = 0.831]. CONCLUSION: The long-term efficacy of SIMS does not differ between the vaginal kits examined.

Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial.

STUDY OBJECTIVE: To compare single-incision mini-slings (SIMSs) and retropubic tension-free vaginal tape (r-TVT) in terms of the long-term efficacy and safety for the treatment of female stress (SUI) or mixed urinary incontinence (MUI). DESIGN: Prospective multicenter cohort trial (registration number NCT00751088) (Canadian Task Force II). SETTINGS: Department of Obstetrics and Gynecology, Italy. PATIENTS: Two hundred-forty women with SUI/MUI. INTERVENTIONS: SIMS or r-TVT. MEASUREMENTS AND MAIN RESULTS: The operative time and the use of analgesic tablets were significantly (p < .001) higher and lower, respectively, in the r-TVT group versus the SIMS group. After 24 months of follow-up, no difference between the study arms was observed in terms of the complication rate (30/120 [25%] vs 19/120 [15.8%] for the r-TVT and SIMS arms, respectively; relative risk = 1.58; 95% confidence interval, 0.94-2.65; p = .083), whereas the subjective cure rate was significantly lower in the SIMS arm than in the r-TVT arm (57/103 [55.3%] vs 89/106 [84.0%] for the r-TVT and SIMS arms, respectively; relative risk = 0.66; 95% confidence interval, 0.54-0.80]; p < .001). The proportion of retreated patients for SUI/MUI was significantly higher in the SIMS arm than in the r-TVT arm (37/103 [34.9%] vs 12/106 [11.3%] for SIMS and r-TVT arm, respectively; p < .001). CONCLUSION: SIMS has no advantage in terms of safety over r-TVT and was found to be less effective than r-TVT. Thus, its use in the clinical practice should be questioned.

A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data.

OBJECTIVE: Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study was to compare three different SIMS in an ambulatory setting. STUDY DESIGN: One hundred and twenty patients with SUI were randomized to receive three SIMS: Ajust, MiniArc, and TVT Secur System. Surgical data were compared. RESULTS: Significantly (P<0.05) lower surgical difficulty and higher patient satisfaction were detected in the MiniArc group when compared to the Ajust and TVT Secur System groups. A significantly (P<0.05) higher feasibility under local anesthesia and in ambulatory setting was also detected for the MiniArc group. The overall complication rate was significantly (P<0.05) lower in the MiniArc group than in the TVT Secur System group. CONCLUSIONS: MiniArc is simpler to insert under local anesthesia and in an ambulatory setting. It is safer than the TVT Secur System, and is related to higher patient satisfaction.

Isolated port-site metastasis after laparoscopic surgery for endometrial cancer: A case report.

► Isolated port-site metastasis is a rare event after laparoscopy in the surgical staging of endometrial cancer. ► More aggressive strategies in case of potentially increased risk for port-site metastasis are needed.

Randomized controlled study comparing the Gynecare Morcellex and Rotocut G1 tissue morcellators.

STUDY OBJECTIVE: To evaluate the effectiveness of the Gynecare Morcellex tissue morcellator (Ethicon, Inc., Somerville, NJ) in laparoscopic supracervical hysterectomy and myomectomy. DESIGN: Randomized controlled trial (Evidence I). SETTING: University department of obstetrics and gynecology. PATIENTS: Seventy-four patients with symptomatic uterine myomas scheduled for laparoscopic supracervical hysterectomy or myomectomy. INTERVENTIONS: Laparoscopic supracervical hysterectomy and myomectomy followed by tissue morcellation using the Gynecare Morcellex (experimental group) or the Rotocut G1 morcellator (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) (control group). MEASUREMENTS AND MAIN RESULTS: Patient characteristics and surgical data were noted for both groups. No difference was detected between groups in any parameters assessed, whereas a significant difference (p <.05) in handling score was detected in the experimental group compared with the control group. CONCLUSION: The Gynecare Morcellex is an effective instrument with excellent safety and handling.

Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study.

OBJECTIVE: To evaluate long-term efficacy of risedronate in osteoporotic postmenopausal patients with inflammatory bowel disease (IBD). DESIGN: A prospective, parallel, open-label, 2-year extension study of a randomized, double-blind, 1-year clinical trial. Eighty-one osteoporotic postmenopausal women with IBD were treated with risedronate (n = 40) or placebo (n = 41). Bone mineral density (BMD), biochemical bone turnover markers, and vertebral and nonvertebral fractures were assessed throughout the study. Data were analyzed using the intent-to-treat principle. RESULTS: Significant (P < 0.05) differences were observed between risedronate and placebo groups at 1-, 2-, and 3-year follow-up visits in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD. In participants treated with risedronate, the percentage of changes from baseline in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD were significantly (P < 0.05) higher at 2- and 3-year follow-up in comparison with baseline and 1-year follow-up, with a significant (P < 0.05) difference between the 2- and 3-year follow-up visits. At the end of the study, the cumulative risk of vertebral and nonvertebral fractures was significantly (P < 0.05) lower in the risedronate group than in the placebo group. The relative risk for new vertebral fractures was 0.456 (95% CI: 0.134-1.559, P = 0.211) and 0.296 (95% CI: 0.121-0.721, P = 0.007) and was 0.209 (95% CI: 0.023-1.867, P = 0.161) and 0.137 (95% CI: 0.030-0.620, P = 0.010), respectively, for new nonvertebral fractures after 2 and 3 years of risedronate treatment. CONCLUSIONS: In postmenopausal osteoporotic women with IBD, long-term treatment with risedronate is effective in increasing BMD and reducing vertebral and nonvertebral fracture risk.

Outlook: metformin use in infertile patients with polycystic ovary syndrome: an evidence-based overview.

Metformin is an insulin sensitizer currently used for treating type-2 diabetes mellitus and recently administered for inducing ovulatory menstrual cycles in oligo-amenorrhoeic patients with polycystic ovary syndrome (PCOS). The aim of the present review is to describe the efficacy of metformin as an ovulation inducer on the basis of the most important evidence-based medicine supported data, including meta-analyses and randomized controlled trials. Specifically, we reviewed the uses of metformin as first- and second-step treatment for PCOS related anovulatory infertility and as co-treatment in infertile PCOS patients who receive gonadotrophins. To date, there is evidence that metformin is effective for restoring normal menstrual cycles in anovulatory PCOS patients, and that it is more effective and cheaper than laparoscopic ovarian drilling as the second therapeutic step in PCOS patients previously defined as resistant to clomiphene citrate. Co-administration of metformin in PCOS patients treated with gonadotrophin improves the mono-ovulation rate and can prevent ovarian hyperstimulation syndrome in patients treated with gonadotrophins for IVF cycles.

Tibolone reverses the cognitive effects caused by leuprolide acetate administration, improving mood and quality of life in patients with symptomatic uterine leiomyomas.

OBJECTIVE: To investigate the effects of tibolone co-administration with GnRH agonist treatment in terms of cognition, mood, and quality of life. DESIGN: Randomized, controlled, single-blind, clinical trial. SETTING: Department of gynecology and obstetrics at a university in Italy. PATIENT(S): One hundred ten premenopausal women with symptomatic uterine leiomyomas. INTERVENTION(S): Six months of treatment with leuprolide acetate depot (11.25 mg IM, every 3 mo) associated with either tibolone (2.5 mg/d orally; group A) or placebo (1 tablet per d; group B). MAIN OUTCOME MEASURE(S): At baseline and after 6 months of treatment, uterine and leiomyoma sizes, leiomyoma-related symptoms, climacteric-like symptoms, cognition, mood, and quality of life. RESULT(S): At study entry, no difference was detected between groups in any parameters assessed. After treatment, the leiomyoma-related symptoms were significantly reduced in both groups, without any statistically significant differences between them. The Kupperman Index was statistically significantly higher in group B in comparison with baseline and group A. The cognition scores were statistically significantly different in comparison with baseline in group B, whereas no change was observed in group A. After treatment, mood and quality of life were statistically significantly improved in both groups, even though the improvement was significantly higher in group A than in group B. CONCLUSION(S): Tibolone administration reverses the deleterious effect on cognition that is caused by leuprolide acetate depot and improves mood and quality of life in patients who receive GnRH agonist for symptomatic uterine leiomyomas.

Is uterine artery embolization for cervical ectopic pregnancy always safe?

The study objective was to assess the feasibility and the efficacy of bilateral uterine artery embolization (BUAE) for the treatment of cervical pregnancy. The design was a series of 3 cases of viable cervical pregnancy diagnosed by transvaginal ultrasonography and treated by means of BUAE and subsequent uterine curettage. Three women with viable cervical pregnancy underwent BUAE and subsequent uterine curettage in the department of obstetrics and gynecology, High Risk Pregnancy Center, University "Federico II" of Naples. Measurements included surgical outcomes and preservation of fertility. The treatment was effective in all cases. Two patients resumed normal menstruation about 1 month after the procedure, whereas 1 patient underwent a hysterectomy 2 weeks after embolization because of acute ischemic degeneration of a concomitant myoma. The conservative management of cervical pregnancy with angiographic BUAE is a feasible and effective option, even if subsequent hysterectomy may be required. Counseling is necessary.

Presurgical assessment of intraabdominal visceral fat in obese patients with early-stage endometrial cancer treated with laparoscopic approach: relationships with early laparotomic conversions.

STUDY OBJECTIVE: To evaluate the relationship between intraabdominal visceral fat (IVF) and early conversion from laparoscopy to laparotomy in obese patients. DESIGN: Prospective study (Canadian Task Force classification II-2). SETTING: Department of obstetrics and gynecology, University "Magna Graecia" of Catanzaro. PATIENTS: One hundred fifty-one obese patients with endometrial cancer and laparoscopic surgery. INTERVENTIONS: Laparoscopic treatment for early-stage endometrial cancer. MEASUREMENT AND MAIN RESULTS: In all patients, demographic, anthropometric (including body mass index, waist-to-hip ratio, and waist circumference), and IVF assessments (using ultrasonography [IVF-USG, cm] and computed tomography [IVF-CT, cm(2)]), were evaluated. In 122 patients (122/151, 80.8%), the laparoscopies were successfully completed (group A), whereas 29 patients (29/151, 19.2%) had a laparotomic conversion. Specifically, in 19 (19/29, 65.5%) and in 10 patients (10/29, 34.5%) the conversion was early (group B1) and late (group B2), respectively. A significant (p <.05) difference in surgical stage IC and in postoperative complications rate was detected between group A and groups B1 and B2, without difference between these 2 last groups. IVF-USG and IVF-CT were significantly (p <.01) higher in group B1 in comparison with groups A and B2, without difference between these 2 last groups. A strong and significant (p <.001) association between IVF-USG and IVF-CT was detected in all groups by Spearman bivariate correlation (r = 0.78, 0.918, and 0.978 for group A, B1, and B2, respectively). Multivariate analysis showed the IVF-CT as the main predictor for early laparotomic conversion (OR 2.184; 95% CI 1.227-3.886). CONCLUSIONS: Intraabdominal visceral fat is a predictor for early laparotomic conversion in obese patients with endometrial cancer. Further studies are necessary to assess the efficacy of the IVF evaluation for reducing the laparotomic conversion risk in obese women undergoing laparoscopic surgery for gynecologic malignancy.