The Light-weight Mid-urethral Sling Implant for Female Stress Urinary Incontinence Treatment: A One-Year Postoperative Follow-up Study.

BACKGROUND: Serasis® (Serag-Wiessner KG, Naila, Germany) is a light-weight mid-urethral sling for treating stress urinary incontinence (SUI). Its insertion is considered less traumatic than other mid-urethral slings. OBJECTIVES: To define postoperative outcomes following Serasis implantation. To compare the efficacy and complication rates of the implant to those of other common techniques. METHODS: Our retrospective study evaluated patients who underwent Serasis mid-urethral sling surgery for SUI. Data were collected from medical records prior to and at the time of surgery and by telephonic interview for postoperative pain and complications. Follow-up of patients was performed for up to one year postoperatively. Patients rated pain or discomfort according to the Visual Analogue Scale (VAS). The primary outcome was the development of early postoperative pain during the first month after surgery. Secondary outcomes were relief of SUI symptoms, groin pain or discomfort, and other postoperative complications up to 12 months after surgery. RESULTS: The study cohort included 50 consecutive patients aged 31 to 68 years. All patients underwent Serasis implantation procedures by a single surgeon and completed interviews. In total, 35 patients underwent concomitant anterior colporrhaphy. In the immediate postoperative period and at one month after the procedure, complaints were mild. No complaints were recorded during the 12-month follow-up period. Overall, 90% and 92% of the patients were free of SUI symptoms at one month and 12 months after surgery, respectively. CONCLUSIONS: Serasis mid-urethral sling is safe, effective, and associated with mild postoperative pain and a low incidence of complications.

Cervical insufficiency a prologue for future pelvic organ prolapse?

BACKGROUND: Preliminary evidence suggests that women with cervical oss insufficiency may have an increased risk to develop pelvic organ prolapse later in life, suggesting a common underlying collagen-oriented mechanism. OBJECTIVE: The objective of this study was to determine the association between cervical oss insufficiency and the subsequent development of pelvic organ prolapse. STUDY DESIGN: A matched, case-control study, including women who delivered at the Soroka University Medical Center. Cases were women diagnosed or treated with pelvic organ prolapse (n = 1463), and controls were a representative sample of women of the same age group without pelvic organ prolapse (n = 5637). The association between pelvic organ prolapse and prior preterm birth was tested. Univariate analysis was performed using a conditional logistic regression to assess the association between preterm labor and pelvic organ prolapse. Statistically and clinically significant variables in the univariate analysis were included in the multivariable regression. RESULTS: The rate of spontaneous preterm birth did not differ between the study groups [pelvic organ prolapse - 4.0% (59/1463) vs. non- pelvic organ prolapse - 4.9% (276/5637), p = 0.16]. The median number of preterm births was higher among women without pelvic organ prolapse (controls) than in those with pelvic organ prolapse (cases) (p = 0.004). Among those who delivered preterm, the individual proportion of preterm deliveries was higher among the controls' group (p = 0.03). Similarly, the rate of cesarean deliveries was also higher among the controls group (p = 0.003). The rate of small for gestational age neonates was higher in the controls group (p = 0.0007), while that of large for gestational age neonates was higher in the case group (p = 0.02). In the univariate analysis, birthweight, vaginal delivery, and prior surgery were associated with subsequent development of pelvic organ prolapse. The multivariable analysis exhibited the same association- having birthweight, vaginal delivery, and all types of prior surgery independently associated with subsequent development of pelvic organ prolapse. CONCLUSIONS: Obstetrics characteristics associated with pelvic organ prolapse included vaginal delivery and birthweight along with non-obstetrical factors such as prior surgery. There was no association between preterm birth and subsequent development of pelvic organ prolapse. Our findings suggest that the effort during labor at term required for the delivery of appropriate for gestational age or large for gestational age newborns affects the pelvic floor and is a major contributor for the subsequent development of pelvic organ prolapse.

The role of hydrodissection in native tissue repair of anterior vaginal wall defects.

AIMS: A variety of surgical techniques are available for vaginal prolapse repair, indicating a lack of consensus. A debate regarding the utility of hydrodissection for splitting the surgical plane of the vaginal wall exists. The aim of this study is to evaluate the impact of hydrodissection in anterior colporrhaphy (AC). MATERIALS: Patients undergoing primary AC were randomly assigned to an approach with (study group) versus without (control group) hydrodissection. Five surgeons performed both techniques, and the trimmed vaginal tissue was retrieved for histological analysis. Two pathologists, blinded to the surgical approach, evaluated the presence of a loose connective tissue at the surgical dissection plane (controversially deemed 'fascia', as explained in this article). In addition, we compared the operative time, pain score and haemoglobin levels. After statistical analysis, data were presented using percentile, and statistical significance was tested using the χ2 and Fisher's exact tests. RESULTS: Forty-six patients underwent primary elective AC, with 23 patients in each, the study and control groups. The groups were comparable regarding age (study group 60.33 ± 11.95 years and control group 59.86 ± 12.04, P = 0.90), menopausal status (study group 17 (73.9%) and control group 15 (68.2%), P = 0.67) and other characteristics. We found no difference in sample characteristics between the two groups. Connective tissue was found in only 13.6% (n = 3) of patients after hydrodissection and in 27.3% (n = 6) of patients without hydrodissection (P = 0.46). The hydrodissection group had significantly less bleeding than the control group (ΔHB 0.66 ± 0.66 vs 1.21 ± 0.84, P = 0.05). CONCLUSIONS: After hydrodissection, less bleeding was noted without compromise the surgical planes.

Subsequent pregnancy outcomes after abdominal vs. laparoscopic myomectomy.

OBJECTIVE: To determine whether abdominal (open) vs. laparoscopic myomectomy affects the obstetrical outcomes of subsequent pregnancies. METHODS: A retrospective cohort study was conducted at a tertiary university medical center. The study population included women who had a documented birth following a myomectomy at our institution between the years 1997 and 2018. The obstetrical characteristics and immediate perinatal outcomes of the subsequent pregnancy following open vs. laparoscopic myomectomy were collected and compared. Data were retrieved from patients' medical records via the institutional computerized database. Cases that lacked detailed surgery and delivery reports were excluded. Data were analyzed using a chi-square test for categorical variables and one-way ANOVA for continuous variables. A p-value <.05 was considered statistically significant. RESULTS: During the study period, 57 women met the inclusion criteria, of whom 66.6% (38/57) had an open and 33.3% (19/57) had a laparoscopic myomectomy. Women who underwent an open myomectomy had a higher rate of cesarean birth than those in the laparoscopic group (89.5 vs. 42.1%, p < .001). No cases of severe maternal or perinatal complications, uterine ruptures, or placental abruptions were identified in either study group. No other significant differences were noted between the two types of myomectomy. CONCLUSION: Open myomectomy is associated with a higher rate of cesarean delivery than laparoscopic. No severe adverse maternal or neonatal outcomes were detected in either study group.

The impact of hymenectomy on future gynecological and obstetrical outcomes.

Background: Imperforated hymen is a rare condition usually diagnosed at puberty due to amenorrhea accompanied by cyclic pelvic pain and sometimes other significant complications such as hematometra, endometriosis, and infertility. The accepted surgical treatment for imperforate hymen and some other hymenal malformation is hymenectomy. However, given low incidence rates, long-term obstetrical and gynecological outcomes in post-hymenectomy women remain poorly understood.Objective: To investigate long-term obstetrical and gynecological outcomes in nulliparous women who underwent a hymenectomy.Study design: Retrospective study comparing gynecological and perinatal outcomes of nulliparous women with and without hymenectomy, who delivered between the years 1988 and 2015 at the Soroka University Medical Center. Univariate analysis was performed as accepted with multivariate logistic regression model used to assess long-term effects of hymenectomy.Results: During the study period, 56 of 74,598 nulliparous women who delivered at the Soroka University Medical Center had previously undergone a hymenectomy. In a univariate analysis, cesarean deliveries were significantly more prevalent among women who had undergone a hymenectomy (30.4 versus 17.6% p = .01) as were infertility treatments (10.7 versus 4.4% p = .04) and dyspareunia (42.9 versus 0.2% p <.001). In a multivariate logistic regression model hymenectomy was found to be an independent risk factor for significant obstetrical and gynecological outcomes defined as one or more of the following: caesarean deliveries, cervical laceration, vaginal laceration, perineal laceration, preterm delivery, cervical incompetence, endometriosis, infertility, and dyspareunia (OR 2.5, 95% CI 1.26-4.93; p = .001).Conclusions: Hymenectomy is associated with significant long-term obstetrical and gynecological complications. Informing medical teams of these risks might promote early detection and minimize associated complications such as laceration-associated blood loss and preterm delivery.

Long-term outcome (5-10 years) after non absorbable mesh insertion compared to partially absorbable mesh insertion for anterior vaginal wall prolapse repair

ABSTRACT Objective: To evaluate long-term (5-10 years) outcomes of Minimally Invasive Surgical (MIS) kit insertion with Prolift® (non-absorbable) mesh compared to the use of Prolift M® (partially absorbable), for anterior vaginal wall prolapse repair. Study design: In this retrospective study we compared women undergoing MIS kit Prolift® insertion (n=90) vs. Prolift M® insertion (n=79) for anterior vaginal wall prolapse repair between 2006 and 2012 at our Institution. A number of 169 women fulfilled the inclusion criteria and were included in the study. Results: During the study period 128 women (76%) completed full follow-up; of them 58 (73%) following MIS kit Prolift® insertion, and 70 (88%) following MIS kit ProliftM® insertion. There was no significant difference between the Prolift® and Prolift M® regarding parity (3.04 vs. 2.88, p=0.506), presence of hypertension (24.1% vs. 39.1%, p=0.088), diabetes mellitus (3.4% vs. 11.6%, p=0.109), or urinary stress incontinence (39.7% vs. 47.1%, p=0.475). All participants had been diagnosed with POP grade 3 or 4 before the procedure. No significant complications during the procedure or postoperative period were identified in the study groups. The follow-up period was at least five years in duration for both groups. Both groups were comparable according to questionnaires focused on function and satisfaction. Conclusion: Patients undergoing MIS kit Prolift® and Prolift M® insertion for anterior vaginal wall prolapse repair had comparable early and late postoperative outcomes. No differences in patient's function and satisfaction between the two groups were identified. According to our findings, there is no superiority to either of the two studied mesh devices.

Comparative analysis of early adverse events of pelvic organ prolapse repair with or without transvaginal mesh using Clavien-Dindo classification.

OBJECTIVE: To assess adverse events following surgical repair of pelvic organ prolapse (POP) with or without the use of transvaginal mesh. METHODS: The present retrospective study was conducted among women who underwent surgical POP repair at Soroka University Medical Center, Beer Sheva, Israel, between January 1, 2013, and December 31, 2015. Patients underwent anterior and posterior colporrhaphy either with transvaginal mesh (Elevate Prolapse Repair System; American Medical Systems, Minnetonka, MN, USA) or without transvaginal mesh (native tissue repair). Perioperative adverse events were assessed using the Clavien-Dindo classification; multivariate regression models were constructed to predict minor and major adverse events. RESULTS: There were 111 women included; 35 were treated with transvaginal mesh, and 76 underwent native tissue repair. Women undergoing native tissue repair had a lower mean grade of cystocele (P=0.023) and a higher rate of urinary stress incontinence (P=0.017) than patients treated with transvaginal mesh. The duration of surgery (P=0.002), duration of hospitalization (P<0.001), and the amount of blood loss (P=0.021) were lower in the native tissue repair group. Repair with transvaginal mesh was not associated with increased odds of major or minor adverse events (P>0.05 for all models examined). CONCLUSION: Perioperative and postoperative adverse events were comparable regardless of the operative approach.

Increased matrix metalloproteinases-1,-9 in the uterosacral ligaments and vaginal tissue from women with pelvic organ prolapse.

OBJECTIVES: To investigate the possible association of increased matrix metalloproteinases (MMPs)-1,-9 with pelvic organ prolapse (POP) and to evaluate whether inflammatory processes contribute to its development. STUDY DESIGN: Forty women who underwent hysterectomy, 20 with POP grade 2 and above, and 20 without POP, participated in the study. Biopsies from the uterosacral ligaments and vaginal mucosa were obtained from each woman. Each biopsy was sectioned and stained for MMP-1 and MMP-9 by immunohistochemical methods and with hematoxylin and eosin (H&E). MMP-1,-9 expressions were evaluated on the immunostained slides. H&E stained sections were examined for possible inflammatory changes. RESULTS: A higher stromal (extra-cellular) expression of MMPs-1,-9 was found in POP cases compared with controls in vaginal biopsies (MMP-1: p=0.004; MMP-9: p=0.042) as well as in uterosacral ligament biopsies (MMP-1: p=0.011; MMP-9: p=0.015). Increased intracellular expression of both MMPs was also demonstrated in fibroblasts in biopsies of women with POP (p<0.001 for all). Most of these differences persisted after controlling for age. The degree of inflammatory changes reflected by the number of lymphocytes, plasma cells and capillary-sized blood vessels per 10 high power fields, was similar in specimens obtained from women with and without POP. CONCLUSIONS: The expression of MMPs-1,-9 appears to be increased in tissues from women with POP. This supports an association, although not a causal relation, between increased MMPs-1,-9 and POP. Inflammation does not seem to play an important role in the pathogenesis of POP.

Peritoneal tuberculosis--an uncommon disease that may deceive the gynecologist.

OBJECTIVES: To document women with peritoneal tuberculosis mimicking ovarian malignancy and to review pertinent literature. STUDY DESIGN: The records of women with peritoneal tuberculosis who were managed at the Soroka Medical Center, Beer-Sheva, Israel between January 2000 and December 2001 were reviewed. RESULTS: Four patients with peritoneal tuberculosis mimicking ovarian malignancy were encountered. Two presented with the classical symptomatology of advanced-stage ovarian carcinoma including ascites, abdominopelvic masses and elevated serum CA-125, and two presented with lower abdominal pain and adnexal mass. Laparoscopy in one patient and laparotomy in three patients revealed peritoneal tuberculosis and no malignancy. Of the three patients who had laparotomy, two underwent unnecessary extended surgery including total hysterectomy, bilateral salpingo-oophorectomy, omentectomy and bilateral pelvic lymphadenectomy, and one had conservative surgery including unilateral salpingo-oophorectomy. All patients were postoperatively treated with quadruple anti-tuberculosis chemotherapy. CONCLUSIONS: Medical awareness of peritoneal tuberculosis is still lacking and many women with this disease are initially thought to have ovarian malignancy and undergo unnecessary extended surgery. Laparoscopy including biopsies seems to be a sufficient and safe method to provide diagnosis of peritoneal tuberculosis. If laparoscopy is not feasible, laparotomy should be performed. If no malignancy is detected and the diagnosis of peritoneal tuberculosis is confirmed, unnecessary extended surgery is avoided and anti-tuberculosis treatment is started.