Annamaria Fabozzi

Tension-Free Vaginal Tape-O and -Secur for the Treatment of Stress Urinary Incontinence: A Thirty-Six–Month Follow-Up Single-Blind, Double-Arm, Randomized Study

OBJECTIVE To compare the efficacy of the inside-out tension-free vaginal tape-obturator (TVT-O) device versus the single-incision TVT-Secur device 36 months after the procedure. METHODS A single-blind, randomized, parallel-group study on 154 patients with stress urinary incontinence (77 treated with TVT-O and 77 with the TVT-Secur hammock approach). The primary endpoint was the objective cure rate 36 months after the procedure evaluated with the challenge stress test. Secondary endpoints were subjective cure rate (evaluated with bladder diary, quality-of-life questionnaires, and patient-reported outcome tools) and intraoperative and postoperative complications. The primary endpoint was evaluated with a noninferiority study design. RESULTS Sixty-six patients in the TVT-O group and 64 in the TVT-Secur group concluded the study. Thirty-six months after the procedure, 57/66 patients (86.4%) in the TVT-O and 50/64 (78.1%) in the TVT-Secur groups were objectively cured (noninferiority unilateral u test: p < .05). No differences were observed in the subjective cure and complication rates. CONCLUSIONS TVT-Secur seems not to be inferior to TVT-O in the surgical treatment of stress urinary incontinence and causes less postoperative pain. The possibility of severe blood loss cannot be ruled out when TVT-Secur is used.

Efficacy of a modified technique for TVT-O positioning: a twelve-month, randomized, single-blind, multicenter, non-inferiority study

OBJECTIVE To evaluate the impact of a more limited paraurethral dissection, avoidance of perforating the obturator membrane with scissors or guide, and a more medial trajectory of the trocar in positioning the TVT-O device on stress urinary incontinence cure rates. STUDY DESIGN One hundred and ten patients were recruited for this randomized, single blind, multicenter, non-inferiority study, with a 1:1 ratio to undergo the traditional (n=55) or the modified (n=55) technique. Preoperatively, patients underwent POP-Q staging, Q-tip test, challenge stress test and urodynamics, and completed the I-QoL, PISQ-12, and PGI-S questionnaires. During the post-operative period, patients attributed a pain VAS score 1, 3, 6, 12 and 24h after the procedure and were followed up at 12 months, undergoing the same baseline evaluations. The primary outcome was the cure rate (absence of urine leaks at the challenge stress test or urodynamic testing) one year after the procedure. The primary outcome was evaluated using a non-inferiority test. RESULTS No differences were observed in cure rates (traditional technique 92.3% vs. modified technique 88.8% and non-inferiority P<0.05) and in questionnaire scores between the two groups. Post-operative pain was significantly lower in the modified technique group at each time point assessed, with the exception of 12h post-operatively. No differences between the two groups were observed in the number of analgesic vials administered. CONCLUSIONS The modified technique does not seem to reduce the efficacy of TVT-O, but induces a reduction of post-operative pain.

Plasma leptin and adiponectin levels in hormone replacement therapy and contraception: effects of different progestogens.

OBJECTIVE To evaluate the impact of hormone replacement therapy and oral contraceptives containing different progestogens on adiponectin and leptin serum levels. DESIGN Prospective, longitudinal, semi-randomized study. SETTING General gynecology clinic of a university hospital. PATIENT(S) Forty-five healthy postmenopausal and 45 healthy premenopausal women. INTERVENTION(S) Thirty postmenopausal women were randomized to receive either drospirenone (DRSP) 2 mg + E(2) 1 mg (n = 15) or norethisterone acetate (NETA) 0.5 mg + E(2) 1 mg (n = 15). Thirty premenopausal women were randomized to receive either ethinilestradiol (EE) 0.020 mg + DRSP 3 mg (n = 15) or EE 0.020 mg + desogestrel 0.15 mg (n = 15). Furthermore, 15 postmenopausal and 15 premenopausal untreated women served as controls. MAIN OUTCOME MEASURE(S) Adiponectin and leptin serum levels before and after 6 months of hormonal therapy. RESULT(S) No significant differences in leptin levels were detected in any group after 6 months. Adiponectin levels were significantly reduced in the NETA + E(2) group and increased in the EE + DRSP group, while remaining unmodified in all other groups. CONCLUSION(S) Hormone replacement therapy with NETA, but not with DRSP, decreases serum adiponectin levels. Oral contraceptives containing DRSP increase serum adiponectin levels.

A case of ovarian torsion in a patient carrier of a FSH receptor gene mutation previously affected by spontaneous ovarian hyperstimulation syndrome.

Abstract We here report a case of ovarian torsion in a patient with an history of two previous episodes of spontaneous ovarian hyperstimulation syndrome during her two pregnancies. A mutation of follicle-stimulating hormone receptor (FSHr) gene was identified in this patient and in other members of the family. Two years after her successful second pregnancy, the patient showed signs of severe thyroiditis during administration of oral contraceptive, with suppressed TSH and increased thyreoglobulin, in the absence of any abnormalities of the auto-antibodies. In few days, she developed severe pelvic pain and ultrasonographic evidence of increased ovarian volume. She underwent laparoscopy with unilateral adnexectomy for ovarian ischemic necrosis due to adnexal torsion. Our experience suggests that patients’ carrier of a mutation of FSHr gene are at risk of ovarian pathologies also when non-pregnant and in the presence of low TSH levels. Further investigations are needed for an appropriate knowledge of typical and atypical manifestations of spontaneous ovarian hyperstimulation syndrome.

Vaginal delivery following single incision sling (TVT-Secur) for female stress urinary incontinence.

In recent years, surgical treatment of stress urinary incontinence has become minimally invasive owing to the introduction of the transobturator route first and then single incision devices for positioning of mid‐urethral slings. Although a number of case reports in the literature describe pregnancies successfully terminated both by vaginal delivery and cesarean section following mid‐urethral sling positioning, there is still no definitive consensus on which is the preferred mode of delivery in these patients. We report a case of spontaneous vaginal delivery at term in a 41‐year‐old multiparous woman two years after the positioning of a single incision sling (TVT‐Secur). The patient remained continent throughout the gestation and in the following 24 months. This case seems to further support the concept that sling procedures for stress urinary incontinence do not represent an absolute contraindication to spontaneous vaginal delivery, although the preferred mode of delivery must be assessed on an individual basis.

An exceptional uterine inversion in a virgo patient affected by submucosal leiomyoma: Case report and review of the literature: Uterine inversion in a virgo patient

Inversion of the uterus is quite a rare obstetric (puerperal) or gynecological (non‐puerperal) condition. Non‐puerperal type may be benign or malign mass induced or idiopathic. To the best of our knowledge, this is the first case with a large review of literature of uterine inversion in a patient without sexual experience. We report the case of a 52‐year‐old, unmarried virgo woman, affected by schizophrenia, was referred to our emergency room for evidence of a mass outside of the vaginal introitus, combined with vaginal bleeding and abdominal pain. The patient underwent vaginal myoma resection and abdominal hysterectomy with bilateral adnexectomy. The diagnosis of uterine inversion was confirmed during operation. Diagnosis of uterine inversion is often not easy and imaging studies might be helpful. Despite the rarity, uterine non‐puerperal inversion is possible: for this reason, it is necessary to perform appropriate, conservative treatment, especially in women affected by benign myomas and with a desire for pregnancy.

O692 COMPARISON OF TVT-O AND TVT-ABBREVO FOR THE SURGICAL MANAGEMENT OF FEMALE STRESS URINARY INCONTINENCE: A 12-MONTHS PRELIMINARY STUDY

Questionnaire (KHQ) and a urinary diary were performed before and 12 months after procedure. Results: 25 patients (10 for TVT-O and 13 for TVT-Secur) were lost at follow-up, leaving a total of 80 patients for TVT-O and 77 for TVT-Secur. Duration of the procedure was significantly lower in the TVT-Secur group (7.8±1.1 minutes vs. 12.8±2.4 minutes; p < 0.05). Blood loss was not different, even though patients from the TVTSecur group tended to have higher percentage of moderate blood loss. A case of severe blood loss was observed in the TVT-Secur group, even though transient. Time to first voiding was significantly higher in the TVT-O group in comparison with TVT-Secur group (90.4±33.5 min. vs. 61.2±1.9 min.; p < 0.05). Objective cure were 86.2% for TVT-O and 80.5% for TVT-Secur (p NS). No intra-operative complications were observed in the two groups. The most frequent post-operative complications was transient leg pain (3 cases; 3.7%) for TVT-O and de novo urgency (5 cases; 6.5%) for TVT-Secur. Two cases of vaginal erosion by the tape was observed in the TVT-Secur group and one in the TVT-O. Post-operative pain VAS scoring was significantly lower in the TVT-Secur group in comparison with the TVT-O group (p < 0.05). Conclusions: Both techniques appear to be safe and effective. TVTSecur shortened operative time and reduced bladder obstruction and thigh pain, but has higher de novo urgency rates. There seems not to be a significant decline in efficacy three years after the procedure in both groups.