Role of fibulin-5 insufficiency and prolapse progression on murine vaginal biomechanical function.

The vagina plays a critical role in supporting the pelvic organs and loss of support leads to pelvic organ prolapse. It is unknown what microstructural changes influence prolapse progression nor how decreased elastic fibers contributes to vaginal remodeling and smooth muscle contractility. The objective for this study was to evaluate the effect of fibulin-5 haploinsufficiency, and deficiency with progressive prolapse on the biaxial contractile and biomechanical function of the murine vagina. Vaginas from wildtype (n = 13), haploinsufficient (n = 13), and deficient mice with grade 1 (n = 9) and grade 2 or 3 (n = 9) prolapse were explanted for biaxial contractile and biomechanical testing. Multiaxial histology (n = 3/group) evaluated elastic and collagen fiber microstructure. Western blotting quantified protein expression (n = 6/group). A one-way ANOVA or Kruskal-Wallis test evaluated statistical significance. Pearson's or Spearman's test determined correlations with prolapse grade. Axial contractility decreased with fibulin-5 deficiency and POP (p < 0.001), negatively correlated with prolapse grade (ρ = - 0.80; p < 0.001), and positively correlated with muscularis elastin area fraction (ρ = - 0.78; p = 0.004). Circumferential (ρ = 0.71; p < 0.001) and axial (ρ = 0.69; p < 0.001) vaginal wall stresses positively correlated with prolapse grade. These findings demonstrated that fibulin-5 deficiency and prolapse progression decreased vaginal contractility and increased vaginal wall stress. Future work is needed to better understand the processes that contribute to prolapse progression in order to guide diagnostic, preventative, and treatment strategies.

Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial.

BACKGROUND: Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Sacrospinous hysteropexy with graft (vaginal mesh hysteropexy) is an alternative, although in 2019 the Food and Drug Administration removed this mesh product from the United States market. OBJECTIVE: Our objective was to compare the efficacy and adverse events of these 2 procedures. STUDY DESIGN: At 9 clinical sites in the United States National Institutes of Health and National Institute of Child Health and Human Development Pelvic Floor Disorders Network, 183 postmenopausal women requesting vaginal surgery for symptomatic uterovaginal prolapse were enrolled in a multisite randomized superiority clinical trial, comparing a sacrospinous hysteropexy with graft (hysteropexy) with a vaginal hysterectomy with uterosacral ligament suspension (hysterectomy). Participants consented to remain masked to treatment assignment for the study duration. Study visits were conducted at 6-month intervals through 60 months. The primary treatment failure composite outcome (retreatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival modeling. Secondary outcomes included complications or adverse events, individual anatomic measures of the pelvic organ prolapse quantification examination, and presence, severity, and impact and bother of prolapse, urinary, bowel, and pain symptoms as measured by validated questionnaires. The 3-year published results suggested better primary outcomes with sacrospinous hysteropexy with graft, but the differences were not statistically significant (P=.06). This study reports the 5-year outcomes. RESULTS: A total of 183 women with a mean age of 66 years were randomized between April 2013 and February 2015; 93 were randomized to hysteropexy and 90 were randomized to hysterectomy. Notably, 175 were included in the trial, and 156 (89%) completed the 5-year follow-up. The primary outcome showed fewer failures for hysteropexy than hysterectomy through 5 years (adjusted hazard ratio, 0.58; 95% confidence interval, 0.36-0.94; P=.03), with failure rates of 37% vs 54%, respectively, resulting in a difference of -18% (95% confidence interval, -33% to -3%) at 5 years. With the exception of the Urogenital Distress Inventory, no group differences were demonstrated in patient-reported pelvic floor symptoms, prolapse symptoms, bowel function symptoms, general quality of life, body image, or pelvic pain. At their last visit through 5 years, 70% of participants (129 of 183) reported they remained masked to their treatment with no difference in masking between groups. Adverse events for hysteropexy vs hysterectomy included mesh exposure (8% vs 0%), granulation tissue after 12 weeks (1% vs 12%), and suture exposure after 12 weeks (3% vs 21%), respectively. CONCLUSION: Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, sacrospinous hysteropexy with graft resulted in a lower composite failure rate than vaginal hysterectomy through 5 years. There were no meaningful differences in patient-reported outcomes between groups. Our results suggest that this vaginal mesh hysteropexy procedure should be made available to patients.

A cross-sectional study on pelvic floor symptoms in women living with Female Genital Mutilation/Cutting.

BACKGROUND: Female Genital Mutilation/Cutting (FGM/C) concerns over 200 million women and girls worldwide and is associated with obstetric trauma and long-term urogynaecological and psychosexual complications that are often under-investigated and undertreated. The aim of this study was to assess the pelvic floor distress and the impact of pelvic floor and psychosexual symptoms among migrant women with different types of FGM/C. METHODS: This cross-sectional study was conducted between April 2016 and January 2019 at the Division of Gynaecology of the Geneva University Hospitals. The participants were interviewed on socio-demographic and background information, underwent a systematic gynaecological examination to assess the presence and type of FGM/C and eventual Pelvic Organ Prolapse (POP), and completed six validated questionnaires on pelvic floor and psychosexual symptoms (PFDI-20 and PFIQ7 on pelvic floor distress and impact, FISI and WCS on faecal incontinence and constipation, PISQ-IR and FGSIS on sexual function and genital self-image). The participants' scores were compared with scores of uncut women available from the literature. The association between selected variables and higher scores for distress and impact of pelvic floor symptoms was assessed using univariate and multivariable linear regression models. RESULTS: 124 women with a mean age of 31.5 (± 7.5), mostly with a normal BMI, and with no significant POP were included. PFDI-20 and PFIQ-7 mean (± SD) scores were of 49.5 (± 52.0) and 40.7 (± 53.6) respectively. In comparison with the available literature, the participants' scores were lower than those of uncut women with pelvic floor dysfunction but higher than those of uncut women without such disorders. Past violent events other than FGM/C and forced or arranged marriage, age at FGM/C of more than 10, a period of staying in Switzerland of less than 6 months, and nulliparity were significantly associated with higher scores for distress and impact of pelvic floor symptoms, independently of known risk factors such as age, weight, ongoing pregnancy and history of episiotomy. CONCLUSIONS: Women with various types of FGM/C, without POP, can suffer from pelvic floor symptoms responsible for distress and impact on their daily life. TRIAL REGISTRATION: The study protocol was approved by the Swiss Ethics Committee on research involving humans (protocol n°15-224).

Long-term Anatomical and Functional Results of Robot-Assisted Pelvic Floor Surgery for the Management of Multicompartment Prolapse: A Prospective Study.

BACKGROUND: Long-term data on robot-assisted sacrocolporectopexy for the treatment of multicompartment pelvic organ prolapse are scarce. With the rising prevalence of prolapse and increasing surgical repair, it is essential to evaluate long-term results. OBJECTIVE: This study aimed to evaluate long-term functional and anatomic outcomes after sacrocolporectopexy. DESIGN: This is a prospective, observational cohort study. SETTINGS: This study was conducted at a teaching hospital with tertiary referral function for patients with gynecological/rectal prolapse. PATIENTS: All patients undergoing robot-assisted sacrocolporectopexy from 2011 to 2012 were included. INTERVENTION: Robot-assisted sacrocolporectopexy was performed. MAIN OUTCOME MEASURES: The primary outcome was the anatomic cure rate after 1 and 4 years, defined as simplified pelvic organ prolapse quantification stage 1 vaginal apical prolapse and no external rectal prolapse or internal rectal prolapse present. Kaplan-Meier curves were used for determination of recurrence-free intervals. Secondary outcomes were functional pelvic floor symptoms (symptoms of bulge, obstructed defecation, fecal incontinence, urogenital distress inventory) and quality of life (Pelvic Floor Impact Questionnaire). RESULTS: Fifty-three patients were included. After 12 and 48 months, the recurrence-free intervals based on Kaplan-Meier estimates were 100% and 90%. In total, there were 10 recurrences: 2 apical and 8 internal rectal prolapses. Symptoms of bulge (94%-12%; p < 0.0005), fecal incontinence (62%-32%; p < 0.0005), obstructed defecation (59%-24%; p = 0.008), and median Pelvic Floor Impact Questionnaire scores (124-5; p = 0.022) improved significantly at final follow-up. Median urogenital distress inventory scores showed improvement after 1 year (30-13; p = 0.021). LIMITATIONS: This was an observational, single-center study with selective postoperative imaging. CONCLUSIONS: Ninety percent of patients were recurrence free 48 months after robot-assisted sacrocolporectopexy. Symptoms of vaginal bulge, quality of life, constipation, and fecal incontinence improved significantly. However, a subgroup of patients showed persistent bowel complaints that underlie the complexity of multicompartment prolapse. See Video Abstract at http://links.lww.com/DCR/B265. RESULTADOS ANATÓMICOS Y FUNCIONALES A LARGO PLAZO DE LA CIRUGÍA DE PISO PÉLVICO ASISTIDA POR ROBOT EN EL TRATAMIENTO DEL PROLAPSO MULTICOMPARTIMENTAL: UN ESTUDIO PROSPECTIVO: Los datos a largo plazo sobre la sacrocolporectopexia asistida por robot para el tratamiento del prolapso multicompartimental de órganos pélvicos son escasos. Con el aumento de la prevalencia del prolapso y el aumento de la reparación quirúrgica, es esencial evaluar los resultados a largo plazo.Evaluar los resultados funcionales y anatómicos a largo plazo después de la sacrocolporectopexia.Estudio prospectivo observacional de cohorte.Hospital de enseñanza con función de referencia terciaria para pacientes con prolapso ginecológico/rectal.Todos los pacientes sometidos a sacrocolporectopexia asistida por robot en 2011-2012.Sacrocolporectopexia asistida por robot.El resultado primario fue la tasa de curación anatómica a uno y cuatro años, definida como etapa 1 de prolapso apical vaginal en la cuantificación del prolapso de órganos pélvicos simplificado, y sin prolapso rectal externo o prolapso rectal interno presentes. Se utilizaron curvas de Kaplan Meier para determinar los intervalos libres de recurrencia. Los resultados secundarios fueron síntomas funcionales del piso pélvico (síntomas de abultamiento, obstrucción defecatoria, incontinencia fecal, inventario de molestias urogenitales) y calidad de vida (cuestionario de impacto del piso pélvico).Se incluyeron 53 pacientes. Después de 12 y 48 meses, el intervalo libre de recurrencia basado en las estimaciones con método Kaplan Meier fue del 100% y 90%, respectivamente. En total hubo diez recurrencias: dos apicales y ocho prolapsos rectales internos. Los síntomas de abultamiento (94% a 12%; p <0.0005), incontinencia fecal (62% a 32%; p <0.0005), obstrucción defecatoria (59% a 24%; p = 0.008) y puntajes promedio del cuestionario de impacto del piso pélvico (124 a 5; p = 0.022) mejoraron significativamente en el seguimiento final. Las puntuaciones medias del inventario de molestias urogenitales mostraron una mejoría después de un año (30 a 13; p = 0.021).Estudio observacional de centro único con imagenología postoperatoria selectiva.Noventa por ciento de los pacientes estaban libres de recurrencia 48 meses después de la sacrocolporectopexia asistida por robot. Los síntomas de abultamiento vaginal, la calidad de vida, el estreñimiento y la incontinencia fecal mejoraron significativamente. Sin embargo, un subgrupo de pacientes mostró molestias intestinales persistentes que subrayan a la complejidad del prolapso multicompartimental. Consulte Video Resumen en http://links.lww.com/DCR/B265.

Prevalence, survival and subsequent fertility of dairy and beef cows with uterine prolapse.

The aim of this study was to evaluate the prevalence of uterine prolapse in cows and assess its effects on survival and subsequent fertility. Of 33,450 calving cows considered retrospectively, 216 (0.6%) developed uterine prolapse. A higher prevalence was found in beef cows (n = 57/5,700 cows, 1%) compared to dairy cows (n = 157/27,750 cows, 0.6%). Treatment consisted of cleaning and replacing the uterus with local administration of antibiotics, and applying a harness for uterine containment. The recovery rate was 81.9% (n = 177), similar in dairy (n = 129; 81.1%) and beef (n = 48; 84.2%) cows. Of the 216 cows with uterine prolapse, 18 (8.3%) died before or immediately after treatment; 21 cows (9.7%) were voluntarily culled for economic reasons (low milk yield, low fertility, insufficient weight gain). All recovered dairy cows were artificially inseminated with semen of proven fertility after a voluntary waiting period of 50 days; the beef cows were naturally mated. Among the 172 inseminated/mated cows, 84.7% (n = 150) became pregnant (83.7% dairy cows, 87.5% beef cows), while 15.2% (n = 27) did not conceive. Recurrence of uterine prolapse at subsequent calvings was recorded in one dairy cow. Based upon the data presented here, treated cows with uterine prolapse showed high chances of survival and conception, and a low risk of recurrence.

Protease Inhibition Improves Healing of The Vaginal Wall after Obstetrical Injury: Results from a Preclinical Animal Model.

Vaginal delivery with obstetrical trauma is a risk factor for pelvic organ prolapse later in life. Loss of fibulin-5 (FBLN5), an elastogenesis-promoting cellular matrix protein, results in prolapse in mice. Here, we evaluated effects of pregnancy, parturition, and obstetrical injury on FBLN5 content, elastic fibers, biomechanics, and histomorphology of the vaginal wall in rats. Further, we analyzed the effects of actinonin, a protease inhibitor, on obstetrical injury of the vaginal wall. Vaginal FBLN5 decreased significantly in pregnancy, and injury resulted in further downregulation. Stiffness of the vaginal wall decreased 82% in pregnant rats and 74% (p = 0.019) with injury relative to uninjured vaginal delivery controls at 3d. Actinonin ameliorated loss of FBLN5, rescued injury-induced loss of elastic fibers and biomechanical properties after parturition, and reduced the area of injury 10-fold. We conclude that pregnancy and parturition have a profound impact on vaginal FBLN5 and biomechanics of the vaginal wall. Further, obstetrical injury has significant deleterious impact on recovery of the vaginal wall from pregnancy. Actinonin, a non-specific matrix metalloprotease inhibitor, improved recovery of the parturient vaginal wall after obstetrical injury.

Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).

OBJECTIVE: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. DESIGN: Randomised controlled trial. SETTING: Thirty-three UK hospitals. POPULATION: Women having surgery for recurrent prolapse. METHODS: Women recruited using remote randomisation. MAIN OUTCOME MEASURES: Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. RESULTS: A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. TWEETABLE ABSTRACT: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.

Comparison of patient reported outcomes, pelvic floor function and recurrence after laparoscopic sacrohysteropexy versus vaginal hysterectomy with McCall suspension for advanced uterine prolapse.

OBJECTIVE: To compare medium/long-term outcomes in terms of pelvic floor function, patient reported prolapse recurrence and repeat prolapse surgery after laparoscopic sacrohysteropexy (LSHP) and vaginal hysterectomy with McCall suspension (VH&McCall) which is the most commonly performed surgical option for severe uterine prolapse from past to present. STUDY DESIGN: Files of patients who underwent LSHP and VH&McCall for advanced utero-vaginal prolapse (stage 3 & 4) at the Department of Gynecology in Ankara University School of Medicine between 2008 and 2018 were reviewed (n = 517). Data of women who were followed up for at least 1-year and containing both the full-filled Patient Global Impression of Improvement (PGI-I) survey and Turkish validated Pelvic Floor Distress Inventory-20 (PFDI-20), were included. RESULTS: A total of 132 women were included in the study; 46 women who underwent LSHP and 86 women who underwent VH&McCall. Even though the median age of the LSHP group was significantly lower than the median age of VH&McCall group (42 vs. 67 years; P<;0.001), recurrence and repeat surgery rates were found to be similar after both surgical approaches as well as the scores of PGI-I and PFDI-20. However, in women who were operated before their sixties, symptomatic recurrence was found to be significantly lower after LSHP than VH&McCall (16.2 % vs. 47.4 %, respectively; P = 0.024) as well as repeat prolapse surgery (2.7 % vs. 26.3 %, respectively; P = 0.014). PGI-I and PFDI-20 scores also suggested better pelvic floor function after LSHP significantly (p = 0.004 & p = 0.003 respectively). When adjusted for age, VH&McCall significantly increased the risk of symptomatic prolapse recurrence compared to LSHP (OR: 4.65; 95 % CI: 1.326-16.312; P = 0.016). CONCLUSION: LSHP and VH&McCall might seem to be surgical options for individualized management with similar pelvic floor function & recurrence in the medium/long-term follow-up, but the age adjusted risk analysis showed higher rates of symptomatic recurrence after VH&McCall. Moreover, the better outcomes after LSHP in the younger subset, revealed the need of further clarification with well-designed prospective studies.

Association between adjuvant posterior repair and success of native tissue apical suspension.

BACKGROUND: Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown. OBJECTIVE: We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success. MATERIALS AND METHODS: This secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial compared 24-month outcomes in 190 participants who had a posterior repair (posterior repair group) and 184 who did not (no posterior repair group) at the time of sacrospinous ligament fixation or uterosacral ligament suspension. Concomitant posterior repair was performed at the surgeon's discretion. Primary composite outcome of "surgical success" was defined as no prolapse beyond the hymen, point C ≤ -2/3 total vaginal length, no bothersome bulge symptoms, and no retreatment at 24 months. The individual components were secondary outcomes. Propensity score methods were used to build models that balanced posterior repair group and the no posterior repair group for ethnographic factors and preoperative Pelvic Organ Prolapse Quantification values. Adjusted odds ratios were calculated to predict surgical success based on the performance of a posterior repair. Groups were also compared with unadjusted χ2 analyses. An unadjusted probability curve was created for surgical success as predicted by preoperative genital hiatus. RESULTS: Women in the posterior repair group were less likely to be Hispanic or Latina, and were more likely to have had a prior hysterectomy and to be on estrogen therapy. The groups did not differ with respect to preoperative Pelvic Organ Prolapse Quantification stage; however, subjects in the posterior repair group had significantly greater preoperative posterior wall prolapse. There were no group differences in surgical success using propensity score methods (66.7% posterior repair vs 62.0% no posterior repair; adjusted odds ratio, 1.07; 95% confidence interval, 0.56-2.07; P = 0.83) or unadjusted test (66.2% posterior repair vs 61.7% no posterior repair; P = 0.47). Individual outcome measures of prolapse recurrence (bothersome bulge symptoms, prolapse beyond the hymen, or retreatment for prolapse) also did not differ by group. Similarly, there were no differences between groups in anatomic outcomes of any individual compartment (anterior, apical, or posterior) at 24 months. There was high variation in performance of posterior repair by surgeon (interquartile range, 15-79%). The unadjusted probability of overall success at 24 months, regardless of posterior repair, decreased with increasing genital hiatus, such that a genital hiatus of 4.5 cm was associated with 65.8% success (95% confidence interval, 60.1-71.1%). CONCLUSION: Concomitant posterior repair at sacrospinous ligament fixation or uterosacral ligament suspension was not associated with surgical success after adjusting for baseline covariates using propensity scores or unadjusted comparison. Posterior repair may not compensate for the pathophysiology that leads to enlarged preoperative genital hiatus, which remains prognostic of prolapse recurrence.

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

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 signifi cant 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 fi ndings, there is no superiority to either of the two studied mesh devices.

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.

Prophylactic McCall Culdoplasty by a Vaginal Approach during Mini-Laparoscopic Hysterectomy.

BACKGROUND: In gynecological surgery, one particular area of concern after hysterectomy is the risk of developing an enterocele or vaginal apical prolapse. The aims of this study were to evaluate the safety and efficacy of prophylactic McCall culdoplasty (MC) performed during mini-total laparoscopic hysterectomy (mini-TLH), as well as to compare the differences in apical support, total vaginal length (TVL), and sexual function at one and two years postoperatively. METHODS: Data were retrospectively reviewed for all women who underwent mini-TLH and mini-TLH + MC at a tertiary care center between August 2012 and January 2016 were from the hospital database. There were 18 women who underwent mini-TLH + MC and were considered as the study group, while 20 women who were treated with mini-TLH were considered as the control group. The primary outcome measures were the differences in apical support and TVL and impact on sexual function. RESULTS: After mini-TLH + MC, the apical vaginal support difference was improved by 2.2 cm. The mean difference in C point was 1.03 cm in the mini-TLH group, which was not significant at two years after the operation. The vaginal vault descent at two years after operation was more prominent in the mini-TLH group than the mini-TLH + MC groups. Apical support changes at two years after the operation were more prominent in the mini-TLH group (0.5 ± 0.6 cm) than the mini-TLH + MC group (1.9 ± 1.2 cm). CONCLUSION: Prophylactic MC by a vaginal approach during mini-TLH is safe, satisfactory, and efficient for apical support without severe morbidity.

[Outcomes of ER:YAG LASER treatment of stress urinary incontinence in women].

AIM: To evaluate the effectiveness of a new method of treatment for stress urinary incontinence in women using an ER: YAG laser in SMOOTH mode and investigate pathophysiological and pathomorphological changes induced by erbium laser. MATERIALS AND METHODS: This study comprised 98 women aged 37-63 years, who between 2014 and 2016 were diagnosed with SUI (type 1 and 2a, 2b) and grade 0-2 vaginal prolapse. The treatment was performed with a 2940 nm Er:YAG laser (Fotona, Slovenia) using a SMOOTH mode. Clinical assessment included PFIQ-7 and PISQ-12 questionnaires, uroflowmetry, laser Doppler flowmetry and biopsy of the anterior vaginal wall. The examination was carried out at baseline and 1-2 months after the treatment. RESULTS: The effectiveness of treatment was 73%. There was no deterioration after the procedure. Analysis of PFIQ-7 and PISQ-12 questionnaires showed that patients with mild incontinence had the greatest difference between pre- and posttreatment results. Uroflowmetry parameters improved in a majority of patients. Results of laser Doppler flowmetry demonstrated the improvement of blood flow in the microvascular bed. An important feature of the vaginal biopsy after laser exposure was an increase in neoangiogenesis. DISCUSSION: The findings of questionnaires and clinical evaluation of patients with SUI and vaginal prolapse before and after treatment with Er: YAG laser showed high therapeutic effectiveness of this treatment modality. CONCLUSION: Clinical effectiveness of ER: YAG laser in SMOOTH mode was 73%. Patients with type 1 and 2a SUI and mild or moderate incontinence have the best prognosis after treatment with this method.

Medium-term follow-up after supervised pelvic floor muscle training for patients with anterior vaginal wall prolapse.

OBJECTIVE: The objective of this study was to determine changes in quality of life, urogenital symptoms, and adherence to pelvic floor muscle training (PFMT) for pelvic organ prolapse (POP) in the medium term. STUDY DESIGN: The present study conducted a pretest-posttest quasi-experimental study design. Of 29 participants in 4-month supervised PFMT, 27 completed all assessments in a follow-up study. Twenty subjects were included in final analysis except 7 participants who underwent surgery during follow-up. To evaluate urogenital symptoms, they completed a prolapse-quality of life (P-QOL) questionnaire and POP-specific QOL. A urologist evaluated the prolapse status of all participants with POP-Q. In addition, the participants were asked about their adherence to PFMT, PFMT obstacles, and where PFMT was performed. All outcome measures were assessed at the following three time points: before PFMT, immediately after PFMT with one-on-one session, and at follow-up via a phone call. Values of p < 0.05 were considered significant. RESULTS: Of the 29 participants in the 4-month supervised PFMT, 27 completed all assessments in a follow-up study (response rate: 93.1%). The percentages of patients who continued PFMT at least 4 times declined substantially in non-operated at follow-up compared with supervised PFMT period. POP-specific QOL such as general health, prolapse impact, and role limitation were significantly worse at follow-up compared with immediately after PFMT despite initial improvement in the short term (p < 0.05). CONCLUSION: POP-specific QOL gradually worsened compared with patients immediately after supervised PFMT in mild to moderate POP women who were followed up without surgery at a 2-year follow-up. Adherence to home-based PFMT might decline without further supervision. It might indicate that to PFMT would be required to maintain symptoms and QOL in medium term. Further study will be needed to clarify if PFMT is effective to improve urogenital symptoms and QOL in long term among the patients with POP.

Pelvic floor muscle weakness: a risk factor for anterior vaginal wall prolapse recurrence.

INTRODUCTION AND HYPOTHESIS: Native tissue vaginal repairs are associated with relatively high levels of recurrence. Systematic reviews have noted that preoperative pelvic floor muscle strength was associated with increased risk of recurrence in the short term. METHODS: This is a retrospective review of patients who underwent a primary reconstructive surgery for anterior compartment vaginal prolapse between 2001 and 2015. Patients were divided into "absent," "weak" and "good" preoperative PFM strength (aPFM, wPFM and gPFM, respectively) based on a modified Oxford scale. Failure rates were determined by a composite of subjective and objective anatomic outcomes. Subjects who underwent re-operations or procedures for recurrent prolapse of the anterior compartment were considered failures. A p value < 0.05 was considered statistically significant. RESULTS: Two hundred ninety-nine patients were included. The aPFM (n = 36), wPFM (n = 115) and gPFM (n = 148) groups had similar descriptive statistics, except subjects in the aPFM and wPFM groups were significantly older than the gPFM group (p = 0.008). All groups underwent similar reconstructive surgeries. Average length of follow-up of 143.9 weeks (41 to 717 weeks) was similar among the three groups (p = 0.472). For the primary outcome of composite failure, aPFM had significantly more anterior vaginal wall recurrences than both the wPFM and gPFM groups, 13.89% vs. 3.48% and 4.05%, respectively (p = 0.033). CONCLUSIONS: Patients with preoperative absent pelvic floor muscle strength (nonfunctioning PFM) had a significantly higher anterior vaginal wall recurrence rate than those with weak or good pelvic floor muscle strength.

Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial.

BACKGROUND: Pelvic organ prolapse (POP) is a common health problem. The lifetime risk of undergoing surgery for prolapse is 11%. POP significantly affects the effects on quality of life and activities of daily living. Laparoscopic sacrocolpopexy (LSC) has been viewed as the gold standard treatment for women with POP who desire reconstructive surgery. However, LSC is associated with technical difficulties, resulting in a long learning curve and operative time. Recently, our team introduced a new laparoscopic technique of inguinal ligament suspension (LILS) and had confirmed its safety and efficacy in treating vaginal vault prolapse. As a new surgical technique for POP, a prospective randomized controlled trial comparing the LILS with the standard technique of LSC is necessary. Therefore, we will conduct a trial. METHODS: The trial is a randomized controlled trial. It compares LILS with LSC in women with stage 2 or higher uterine prolapse. The primary outcomes of this study are perioperative parameters, including surgical time, blood loss, intraoperative complications, and hospital stay as well as surgical anatomical results using the pelvic organ prolapse questionnaire (POP-Q) classification at 6 weeks, 6 months, 12 months, and annually till 5 years after surgery. Secondary outcomes are subjective improvement in urogenital symptoms and quality of life, postoperative complications, postoperative recovery, sexual functioning, and cost-effectiveness at each follow-up point. Validated questionnaires will be used and the data will be analyzed according to the intention-to-treat principle. Based on an objective success rate of 90%, a noninferiority margin of 15%, and a dropout of 20%, 107 patients are needed in each arm to prove the hypothesis with a 95% confidence interval. DISCUSSION: The trial is a randomized controlled, multicenter, noninferiority trial that will provide evidence whether the efficacy and safety of LILS is noninferior to LSC in women with symptomatic stage 2 or higher uterine prolapse. TRIAL REGISTRATION: China Trial Register (CTR): ChiCTR-INR-15007408 . Registered on 9 November 2015.

Long-term experience with a novel uterine-sparing transvaginal mesh procedure for uterovaginal prolapse.

OBJECTIVES: To evaluate outcomes and quality of life in patients operated transvaginally with an original mesh shape for uterus-sparing prolapse surgery and to demonstrate the safety and efficacy of the technique. STUDY DESIGN: We prospectively evaluated 66 postmenopausal patients (POP-Q Stage III: 32, IV: 34) operated between May 2008 and December 2013. We used wide weave polypropylene monofilament mesh that functions as a hammock anchored posteriorly to sacrospinous ligaments, its anterior wings exit the pelvis through the obturatory membrane. Follow-up was scheduled at 3-, 12- months and in May 2016. Prolapse-Quality of Life Questionnaire (P-QoL) was administered preoperatively, at 12 months and in May 2016. The chi square and Wilcoxon test were used for statistical analysis. RESULTS: Mean follow-up was 5.6 (SD: 1.6, Range: 1.1-8.1) years. The overall success rate (POP-Q ≤ 2) was 92.5% at 12 months and 84.4% at May 2016, these data remained stable over time (p > 0.05). Early complications occurred in 2 (3%) patients, late in 5 (7.8%) of which mesh extrusion in 4 (6.3%). Data from P-QoL showed significant improvement between preoperative and postoperative data (P < 0.01 for all domains) and they remained stable with time (p > 0.05). De-novo dyspareunia was 17.6% at 12 months and 10.3% at May 2016. CONCLUSIONS: The low rate and grade of complications demonstrates the safety of the procedure, which offers stable anatomical correction with significant improvement in QoL.

The predictive value of demonstrable stress incontinence during basic office evaluation and urodynamics in women without symptomatic urinary incontinence undergoing vaginal prolapse surgery.

AIMS: Women with pelvic organ prolapse without symptoms of urinary incontinence (UI) might demonstrate stress urinary incontinence (SUI) with or without prolapse reduction. We aimed to determine the value of demonstrable SUI during basic office evaluation or urodynamics in predicting SUI after vaginal prolapse repair in these women. METHODS: Women included in the CUPIDO trials without bothersome UI or UI more than once a week were eligible if they had undergone prolapse repair without incontinence surgery. The diagnostic and predictive value of demonstrable SUI was studied for postoperative SUI (POSUI). POSUI was defined as bothersome SUI at 1-year follow-up or treatment for SUI in the first postoperative year. RESULTS: In 45% (77/173) of the included women urodynamics was performed. In 19% (32/172) SUI was demonstrated with basic office evaluation, against 29% (22/77) with urodynamics. Nine percent (16/172) developed POSUI, six women underwent surgery for de novo SUI. Women with demonstrable SUI were more at risk to face POSUI: twenty-eight percent versus five percent (Diagnostic Odds Ratio: 7; 95%CI 3-22). Urodynamics predicted one more woman having POSUI, but all women who underwent treatment for de novo SUI showed SUI during basic office evaluation. Test performance did not improved with the adding of urodynamics. CONCLUSIONS: The predictive value of demonstrable SUI in symptomatically continent women undergoing vaginal prolapse repair is limited. Urodynamics added no value. The twenty-eight percent POSUI risk must be balanced against the increased complication risk if a prophylactic midurethral sling is considered.

Effects of Pneumoperitoneum and the Steep Trendelenburg Position on Heart Rate Variability and Cerebral Oxygenation during Robotic Sacrocolpopexy.

STUDY OBJECTIVE: The aim of this study was to investigate how steep Trendelenburg positioning with pneumoperitoneum modifies brain oxygenation and autonomic nervous system modulation of heart rate variability during robotic sacrocolpopexy. DESIGN: Prospective study (Canadian Task Force classification III). SETTING: Rambam Health Care Campus. PATIENTS: Eighteen women who underwent robotic sacrocolpopexy for treatment of uterovaginal or vaginal apical prolapse. INTERVENTIONS: Robotic sacrocolpopexy. MEASUREMENTS AND MAIN RESULTS: A 5-minute computerized electrocardiogram, cerebral O2 saturation (cSO2), systemic O2 saturation, heart rate (HR), diastolic blood pressure (BP), systolic BP, and end-tidal CO2 tension were recorded immediately after anesthesia induction (baseline phase) and after alterations in positioning and in intra-abdominal pressure. HR variability was assessed in time and frequency domains. Cerebral oxygenation was measured by the technology of near-infrared spectrometry. cSO2 at baseline was 73% ± 9%, with minor and insignificant elevation during the operation. Mean HR decreased significantly when the steep Trendelenburg position was implemented (66 ± 10 vs 55 ± 9 bpm, p < .05) and returned gradually to baseline with advancement of the operation and the decrease in intra-abdominal pressure. Concomitant with this decrease, the power of both arms of the autonomic nervous system increased significantly (2.8 ± .8 vs 3.3 ± .9 ms2/Hz and 2.5 ± 1.2 vs 3.2 ± .9 ms2/Hz, respectively, p < .05). All these effects occurred without any significant shifts in systolic or diastolic BP or in systemic or cerebral oxygenation. CONCLUSION: This study supports the safety of robotic sacrocolpopexy performed with steep Trendelenburg positioning with pneumoperitoneum. Only minor alterations were observed in cerebral oxygenation and autonomic perturbations, which did not cause clinically significant alterations in HR rate and HR variability.