A prospective study comparing rectal water contrast-transvaginal ultrasonography with sonovaginography for the diagnosis of deep posterior endometriosis.

INTRODUCTION: Preoperative assessment of deep endometriotic (DE) nodules is necessary to inform patients about the possible treatments and provide informed consent in case of surgery. This study aims to investigate the diagnostic performance of rectal water-contrast transvaginal ultrasonography (RWC-TVS) and sonovaginography (SVG) in women with suspicion of posterior DE. MATERIAL AND METHODS: This prospective comparative study (NCT04296760) enrolled women with clinical suspicion of DE at our institution (Piazza della Vittoria 14 SRL, Genoa, Italy). Exclusion criteria were previous diagnosis of DE by imaging techniques or laparoscopy. All patients underwent RWC-TVS and SVG, independently performed by two gynecological sonologists blinded to the other technique's results. Patients underwent laparoscopic surgery within the following three months; imaging findings were compared with surgical and histological results. RESULTS: In 208 of 281 (74.0%) patients included, posterior DE was surgically confirmed in rectosigmoid (n = 88), vagina (n = 21), rectovaginal septum (n = 34) and uterosacral ligaments (n = 156). RWC-TVS and SVG demonstrated similar sensitivity (SE; 93.8% vs 89.4%; p = 0.210) and specificity (SP; 86.3% vs 79.4%; p = 0.481) in diagnosing posterior DE. Specifically, both examinations had similar accuracy in detecting nodules of uterosacral ligaments (p = 0.779), vagina (p = 0.688) and rectovaginal septum (p = 0.824). RWC-TVS had higher SE (95.2% vs 82.0%; p = 0.003) and similar SP (99.5% vs 98.5%; p = 0.500) in diagnosing rectosigmoid endometriosis and estimated better infiltration of intestinal submucosa (p = 0.039), and distance between these nodules and anal verge (p < 0.001); only RWC-TVS allowed the estimation of bowel lumen stenosis. A similar proportion of discomfort was experienced during both examinations (p = 0.191), although a statistically higher mean visual analog score was reported during RWC-TVS (p < 0.001). CONCLUSIONS: Although RWC-TVS and SVG have similar accuracy in the diagnosis of DE, RWC-TVS performed better in assessment of the characteristics of rectosigmoid endometriosis.

Ultrasonographic 3D Evaluation in the Diagnosis of Bladder Endometriosis: A Prospective Comparative Diagnostic Accuracy Study.

OBJECTIVE: The use of three-dimensional (3D) transvaginal ultrasonography (TVS) has been investigated for the diagnosis of deep endometriosis (DE). This study aimed to evaluate if 3D reconstructions improve the performance of TVS) in assessing the presence and characteristics of bladder endometriosis (BE). DESIGN: This was a single-center comparative diagnostic accuracy study. Participants/Materials, Setting, Methods: Patients referred to our institution (Piazza della Vittoria 14 Srl, Genova, Italy) with clinical suspicion of DE were included. In case of surgery, women underwent systematic preoperative ultrasonographic imaging; an experienced sonographer performed a conventional TVS; another experienced sonographer, blinded to results of the previous exam, performed TVS, with the addition of 3D modality. The presence and characteristics of BE nodules were described in accord with International DE Analysis group consensus. Ultrasound data were compared with surgical and histological results. RESULTS: Overall, BE was intraoperatively found in 34 out of 194 women who underwent surgery for DE (17.5%; 95% confidence interval: 12.8-23.5%). TVS without and with 3D reconstructions were able to detect endometriotic BE in 82.2% (n = 28/34) and 85.3% (n = 29/34) of the cases (p = 0.125). Both the exams similarly estimated the largest diameter of BE (p = 0.652) and the distance between the endometriotic nodule and the closest ureteral meatus (p = 0.341). However, TVS with 3D reconstructions was more precise in estimating the volume of BE (p = 0.031). In one case (2.9%), TVS without and with 3D reconstructions detected the infiltration of the intramural ureter, which was confirmed at surgery and required laparoscopic ureterovesical reimplantation. LIMITATIONS: The extensive experience of the gynecologists performing the ultrasonographic scans, the lack of prestudy power analysis, and the population selected, which may have been influenced by the position of the institution as a referral center specialized in the treatment of severe endometriosis, are limitations of the current study. CONCLUSION: Our results demonstrated the high accuracy of ultrasound for diagnosing BE. The addition of 3D reconstructions does not improve the performance of TVS in diagnosing the presence and characteristics of BE. However, the volume of BE may be more precisely assessed by 3D ultrasound.

Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae?

Due to the high number of cesarean sections over the last two decades, there has been a growing awareness of the post-surgical obstetric long-term sequelae (i.e., uterine scar defects and abnormal placentation) following this surgical procedure. Knotless barbed suture is an absorbable bidirectional and unidirectional monofilament, characterized by the presence of "barbs" along its length. After being introduced in gynecology, the favorable features of the knotless barbed suture, such as the uniform distribution of tensile force, provide the rationale for studying its benefits in obstetric surgery. Recently, our research group has investigated a double-layer barbed suture ("fishbone" suture) for closing the uterine wall during cesarean section by a case-control study, reporting a low incidence of uterine scar defects and a reduced size of defects in women who had developed them (NCT04825821). In the near future, large prospective studies are strongly awaited to investigate reproductive outcomes and long-term sequelae after cesarean section performed with knotless barbed suture.

Ulipristal Acetate Before High Complexity Hysteroscopic Myomectomy: A Retrospective Comparative Study.

STUDY OBJECTIVE: To evaluate the efficacy of preoperative treatment with ulipristal acetate (UPA) in patients undergoing high complexity hysteroscopic myomectomy. DESIGN: Retrospective analysis of a prospectively collected database (Canadian Task Force classification II-2). SETTING: University teaching hospital. PATIENTS: Patients of reproductive age requiring hysteroscopic myomectomy with STEPW (size, topography, extension, penetration, and wall) score 5 or 6. INTERVENTIONS: Patients included in the study either underwent direct surgery (group S) or received a 3-month preoperative treatment with UPA (group UPA). Based on a power calculation, 25 patients were required in each study group. MEASUREMENTS AND MAIN RESULTS: Myoma characteristics were similar in the 2 study groups. The 3-month UPA treatment caused a 21.9% (±10.3%) mean (±SD) percentage decrease in myoma volume. The number of complete resections (primary outcome of the study) was higher in group UPA (92.0%) than in group S (68.0%; p = .034). The operative time was lower in group UPA than in group S (p = .048), whereas there was no significant difference in fluid balance between the 2 study groups (p = .256). The incidence of complications was similar in the 2 groups (p = .609). Patient satisfaction at 3 months from surgery was higher in group UPA than in group S (p = .041). CONCLUSION: A 3-month preoperative treatment with UPA increases the possibility of complete resection in high complexity hysteroscopic myomectomy. It decreases the operative time and improves patient satisfaction at 3 months from surgery.

Vaginal sacrospinous colpopexy using the Capio suture-capturing device versus traditional technique: feasibility and outcome.

PURPOSE: This study compares the feasibility and outcome of sacrospinous colpopexy for treating vaginal vault prolapse (VVP) performed by either the traditional technique or a simplified procedure using the Capio™ suture-capturing device. MATERIALS AND METHODS: Eighty-six patients with VVP were included in the study. Forty-two patients were treated by traditional sacrospinous colpopexy (TSC group) and 44 patients were treated by the modified technique using the Capio device (CSC group). Additional procedures were performed to restore concomitant pelvic floor defects. RESULTS: The mean (±SD) total operative time was significantly lower in the CSC group (71.7 ± 24.5 min) than in the TSC group (105.5 ± 31.5 min; p < 0.001); the intraoperative blood loss was higher in the TSC group than in the CSC group. In the CSC group, the mean operative time required to perform sacrospinous colpopexy was 21.4 ± 3.2 min. In patients who underwent only sacrospinous colpopexy, the time required to perform surgery was significantly lower in the CSC group (20.9 ± 3.3 min) than in the TSC group (39.1 ± 5.2 min; p < 0.001). There was no significant difference in the incidence of surgical complications between the two study groups. The objective and subjective success rates at 3-year follow-up were 88.1 and 92.9 % in the TSC group while in the CSC group they were 86.4 and 92.9 %. CONCLUSION: The modified technique of sacrospinous ligament fixation using the Capio device reduces the operative time and blood loss when compared to the traditional technique.

Outpatient periurethral injections of polyacrylamide hydrogel for the treatment of female stress urinary incontinence: effectiveness and safety.

PURPOSE: To investigate the effectiveness and safety of periurethral injections (PIs) of polyacrylamide hydrogel (PAHG, Bulkamid(®)) for the treatment of female stress urinary incontinence (SUI). METHODS: This double-centre prospective study included 82 female patients with SUI who were treated with PIs of PAHG between January 2008 and December 2010 in outpatient setting. The International Consultation on Incontinence Questionnaire short form (ICIQ-SF) and the Patient Global Improvement Impression (PGI-I) were used to assess incontinence and patient satisfaction after treatment. The impact of incontinence on quality of life (QoL) was investigated using the Incontinence Impact Questionnaire (IIQ-7). RESULTS: All patients were discharged on the same day of treatment and there was no intraoperative complication. At 1-year follow-up, the efficacy of PIs of PAHG (subjective success rate) was 74.4 %. The subjective responder rate was 86.6 %, 8.5 % of patients had no change and no patient reported worsening of symptoms. The mean number of episodes of urine leakage/24 h and the mean leakage/24 h significantly decreased after treatment. At 1-year follow-up, the IIQ-7 results were significantly improved compared with baseline. 25.6 % of patients had adverse events (mainly urinary tract infections and injection site pain). CONCLUSION: This study demonstrates that PIs of PAHG are effective and safe and cause significant improvement of the QoL at 1-year follow-up. PIs of PAHG can be safely performed in an ambulatory setting and patients may be discharged on the day of the procedure.

Incidence and ultrasonographic characteristics of cesarean scar niches after uterine closure by double-layer barbed suture: A prospective comparative study.

OBJECTIVE: To compare the ultrasonographic features of uterine scars and clinical symptoms after cesarean delivery (CD) using barbed and conventional smooth sutures. METHODS: This case-control study enrolled women who underwent primary CD at 37 weeks of pregnancy or later. The uterus was closed using either double-layer unidirectional barbed suture or conventional double-layer smooth suture. Ultrasound scans of the uterine scar and evaluations of menstrual patterns were performed at 6, 12, and 24 months after surgery. RESULTS: In all, 102 patients underwent uterine closure with barbed suture, while 135 patients underwent smooth suture. At 6 months, patients in the barbed group had a lower incidence of uterine niches (20.2% vs 32.6%) that were also shallower in depth (P < 0.001). Lower incidence of niches was also observed in the barbed group at 12 and 24 months (P = 0.043 and 0.048, respectively). At these two follow-up times, the smooth group had a higher number of patients reporting postmenstrual spotting (P < 0.05) and more postmenstrual spotting days per month (P < 0.050). CONCLUSION: The use of double-layer barbed suture during CD was associated with a lower incidence of scar niches and a more favorable menstrual pattern compared with the use of smooth suture.

Periurethral injection of polyacrylamide hydrogel for the treatment of stress urinary incontinence: the impact on female sexual function.

INTRODUCTION: Urinary incontinence can negatively affect sexual function. AIM: To investigate sexual function in female patients treated for urodynamic stress incontinence (USI) by periurethral injections. METHODS: This double-center prospective study included 29 female patients who were treated for USI by periurethral injections of polyacrylamide hydrogel (Bulkamid(®); Ethicon Women's Health and Urology, Contura, Denmark). MAIN OUTCOME MEASURES: Patients answered the International Consultation on Incontinence Questionnaire short form, the Incontinence Impact Questionnaire, and the Patient Global Improvement Impression. The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) was used to evaluate sexual function at baseline and at 1-year follow-up. Patients were also asked to rate their sexual activity by using a 10-mm visual analog scale at baseline and at 12-month follow-up. Subjective and objective success was examined. RESULTS: All patients were discharged on the same day of treatment and there was no intraoperative complication. At 1-year follow-up, the subjective success rate was 89.7% and the objective success rate was 79.3%. At 1 year from the first treatment, all the 23 sexually active patients continued to have regular sexual life. Six women reestablished sexual activity after the treatment. The total PISQ-12 scores showed a significant improvement in quality of sexual life of patients who were sexually active before surgery. CONCLUSIONS: Periurethral injections of polyacrylamide hydrogel to treat USI are clinically effective and safe. These surgical procedures cause significant improvements in sexual function and sexual satisfaction of patients.

Unidirectional barbed suture versus continuous suture with intracorporeal knots in laparoscopic myomectomy: a randomized study.

STUDY OBJECTIVE: To estimate the effectiveness of unidirectional knotless barbed suture and continuous suture with intracorporeal knots in the repair of uterine wall defects during laparoscopic myomectomy. DESIGN: Randomized clinical study (Canadian Task Force Classification I). SETTING: Single-center study in a university hospital. PATIENTS: This study enrolled 44 women who underwent laparoscopic myomectomy. INTERVENTIONS: In accord with to the randomization, the uterine wall defects were closed either with a continuous suture with intracorporeal knots (group V) or a unidirectional knotless barbed suture (group L). MEASUREMENTS AND MAIN RESULTS: The time required to suture the uterine wall defect was significantly lower in group L (11.5 ± 4.1 minutes) than in group V (17.4 ± 3.8 minutes; p <.001). However, no significant difference was observed in the operative time between the 2 study groups. The intraoperative blood loss was significantly lower in group L than in group V (p =.004). The degree of surgical difficulty was significantly lower in group L (3.7 ± 1.1) than in group V (6.1 ± 2.1; p <.001). CONCLUSION: The unidirectional knotless barbed suture may facilitate the suture of uterine wall defects during laparoscopic myomectomy. When compared with continuous suture and intracorporeal knots, the barbed suture reduces the time required to suture the uterine wall defect and the intraoperative blood loss.

Transobturator adjustable tape (TOA) in female stress urinary incontinence associated with low maximal urethral closure pressure.

PURPOSE: To determine the success rate of transobturator adjustable tape (TOA, Agency for Medical Innovations, A.M.I., Austria) in stress urinary incontinent patients with maximal urethral closure pressure (MUCP) < or =20 cm H(2)O compared to those with MUCP >20 cm H(2)O. MATERIALS AND METHODS: In this retrospective study, all female patients with a diagnosis of stress urinary incontinence underwent TOA, from September 2005 to August 2007. All patients had preoperative multichannel urodynamic tests (cystometry, urethral profile and uroflowmetry). During September 2008, patients were contacted by telephone and the validated short forms of the Urogenital Distress Inventory (UDI-6) questionnaire and the Incontinence Impact Questionnaire (IIQ-7) were administered. RESULTS: The chart review identified 146 patients (125 with MUCP >20 cm H(2)O and 21 with MUCP < or =20 cm H(2)O) who had undergone TOA and who met the inclusion criteria. Of these, 121 patients (82.9%) were contacted by telephone. Results showed a very good quality of life (score 0-7 in the IIQ-7) in 95.9% of patients. Only two (1.6%) patients had persistent significant urine leakage related to physical activity. In the MUCP < or =20 cm H(2)O group, 90% of patients could be considered as being very satisfied, with a very good quality of life. CONCLUSION: With the TOA procedure, the obturator route could be used to treat patients with urinary incontinence and also with low MUCP.

Current and experimental drug therapy for the treatment of polycystic ovarian syndrome.

INTRODUCTION: Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects 8-13% of reproductive-age women. Irregular periods, hirsutism, or infertility are the most common clinical presentations of patients affected by PCOS. This syndrome is also linked to metabolic abnormalities such as type 2 diabetes, insulin resistance and obesity. The optimal therapeutic approach is still unknown. AREAS COVERED: This narrative review offers an overview of the literature on current and experimental pharmacological options for treating PCOS and highlights ongoing clinical trials. Several electronic databases were searched and current research registers were analyzed to the present year. The papers selected for this review were critically analyzed, and all data available were summarized, organized, and explored to derive key information. EXPERT OPINION: The main goal of PCOS treatment is to obtain a metabolic and hormonal balance. Optimal PCOS therapy should be direct to the reproductive abnormalities and the entire spectrum of endocrine and metabolic complications that appear to have a long-term negative impact on PCOS patient health, as in post-menopausal period. The discovery of new mechanisms in PCOS pathogenesis will offer the possibility of testing new drug classes.

Bowel preparation before laparoscopic gynaecological surgery in benign conditions using a 1-week low fibre diet: a surgeon blind, randomized and controlled trial.

PURPOSE: The aim of this randomized, surgeon-blind, controlled study was to evaluate the role of a 7 days minimal-residue (low fibre intake) pre-operative diet compared with a mechanical bowel preparation in laparoscopic benign gynaecological surgery. METHODS: This was a randomized, surgeon-blind, controlled study. The study included 83 women scheduled to undergo diagnostic or operative laparoscopy for various gynaecological benign conditions. Exclusion criteria were suspicion of malignancy, associated non-gynaecological surgical pathologies, severe endometriosis, and history of previous abdominal surgery. Study group had a total daily fibre intake inferior to 10 g for a week before the operation (n = 42). Control group had a mechanical bowel preparation the day before the operation (n = 41). The principal measures of outcome were the quality of bowel preparation, the acceptability of the preoperative diet and of the mechanical bowel preparation. Secondary outcomes included postoperative pain, time of ambulation, length of postoperative ileus, and length of postoperative hospital stay. RESULTS: The two treatment groups were comparable with respect to demographic characteristics and indications for surgery. Preoperatively, abdominal distension and overall discomfort were significantly more frequent in the control group (P = 0.061 and 0.034 respectively). There was no significant difference in the small and large bowel preparation between the two groups. Postoperatively, no significant difference was observed between the two groups in pain, nausea, abdominal swelling, length of ileus, and of postoperative stay. CONCLUSIONS: This study shows that preoperative low fibre diet and mechanical bowel preparation provide similar quality of surgical field exposure. However, when compared with mechanical bowel preparation, preoperative low fibre diet may be better tolerated by the patients, thus increasing compliance. Moreover, a 7 days preoperative low fibre diet allow the patient to continue working and social activities until the day of surgery without requiring admission to the hospital or home bowel preparation on the day before surgery.

Symptomatic endometriosis of the posterior cul-de-sac is associated with impaired sleep quality, excessive daytime sleepiness and insomnia: a case-control study.

OBJECTIVE: To assess the impact of endometriosis of the posterior cul-de-sac on quality of sleep, average daytime sleepiness and insomnia. STUDY DESIGN: This age-matched case-control study was conducted in a tertiary referral centre for the diagnosis and treatment of endometriosis between May 2012 and December 2013. It included 145 women with endometriosis of the posterior cul-de-sac (cases; group E) and 145 patients referred to our Institution because of routine gynaecologic consultations (controls; group C). This study investigated whether sleep is impaired in patients with endometriosis of the posterior cul-de-sac. Sleep quality, daytime sleepiness and insomnia were assessed using the following self-administered questionnaires: the Pittsburgh Sleep Quality Index, the Epworth sleepiness scale and the Insomnia Severity Index, respectively. The primary objective of the study was to evaluate sleep quality in the two study groups. Secondary outcomes of the study were to assess average daytime sleepiness and insomnia in the two study groups. RESULTS: The prevalence of poor sleep quality was significantly higher in group E (64.8%) than in group C (15.1%; p<0.001). The prevalence of excessive daytime sleepiness was significantly higher in group E (23.4%) than in group C (12.9%; p=0.033). Patients of group E experienced subthreshold insomnia (29.0%) and moderate clinical insomnia (16.6%) significantly more frequently than patients in group C (24.4% and 5.0%; p=0.002). CONCLUSION: A substantial proportion of women with endometriosis of the posterior cul-de-sac experiences poor sleep quality, excessive daytime sleepiness and insomnia.

What is the desired menstrual frequency of women without menstruation-related symptoms?

INTRODUCTION: This study aimed to investigate the desired menstrual frequency of subjects without menstruation-related symptoms. MATERIALS AND METHODS: The study included 270 women of reproductive age. Women with menstrual headache, dysmenorrhea, hypermenorrhea and/or premenstrual syndrome were excluded. The study subjects completed a standardized questionnaire. RESULTS: Of the women, 75.6% declared that menstrual periods interfere with their sexual life, 28.8% preferred not having their menstrual period when at work and 48.4% reported that menstrual periods interfere with practicing sports. Given the choice, 28.5% of the women would desire amenorrhea and 27.8% would prefer a reduction in the frequency of menstrual periods. Of the 152 women desiring to reduce menstrual frequency, 73.0% declared that they would accept to use a drug to reduce menstrual frequency. CONCLUSIONS: Over 50% of women without menstruation-related symptoms would like to lessen the frequency of menstrual periods and about 50% of them would desire amenorrhea.

Three-month treatment with ulipristal acetate prior to laparoscopic myomectomy of large uterine myomas: a retrospective study.

OBJECTIVE: To assess the usefulness of 3-month treatment with ulipristal acetate (UPA) before laparoscopic myomectomy of large uterine myomas. STUDY DESIGN: This retrospective analysis of a prospectively collected database included women of reproductive age requiring laparoscopic myomectomy with the following characteristics: FIGO type 3, 4 or 5 myomas; largest diameter of the main myoma ≥10cm; number of myomas ≤3; largest diameters of the other myomas ≤5cm (second myoma) and ≤3cm (third myoma). Patients either underwent direct surgery (group S) or were treated before surgery with UPA for 3 months (group UPA). RESULTS: The mean (±SD) intraoperative blood loss was lower in group UPA (507.1±214.9ml) than in group S (684.2±316.8; p=0.012). The total operative time was lower in group UPA (137.6±26.8min) than in group S (159.7±26.8min; p<0.001); there was no significant difference in the suturing time between the two study groups (p=0.076). Hemoglobin drop was lower in group UPA (1.1±0.5g/dl) than in group S (1.3±0.7g/dl; p=0.034). Six patients in group S and no patient in group UPA required postoperative blood transfusions (p=0.031). Complications were not different between the two groups (p=0.726). Moreover, preoperative treatment with UPA caused a significant increase in hemoglobin levels (11.9±1.6g/dl) compared with baseline (9.1±1.1g/dl; p<0.001). CONCLUSION: A 3-month treatment with UPA before laparoscopy for large uterine myomas decreases intraoperative blood loss, hemoglobin drop, postoperative blood transfusion and length of surgery.