Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.

BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).

Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial.

BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. OBJECTIVE: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. RESULTS: Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss-related outcomes.

Reoperation rate and outcomes following the placement of polypropylene mesh by the vaginal route for cystocele: very long-term follow-up.

INTRODUCTION AND HYPOTHESIS: The aim was to evaluate the reoperation rate and outcomes in women who underwent transvaginal non-absorbable monofilament polypropylene mesh placement for the treatment of cystocele. METHODS: The retrospective cohort study included 63 patients who underwent transvaginal surgery using a synthetic polypropylene mesh (Gynemesh™) for cystocele. Patients were evaluated using a clinical examination (POP-Q) and validated questionnaires (PGI-I, PFDI-20, PFIQ-7) at 18 years of follow-up (median 18 years [IQR 16-19]). Cumulative death rate was 13 out of 63 (20%) and rate of total loss to follow-up was 21 out of 50 (42%). Finally, among the 63 women who underwent surgery, 29 completed maximum follow-up and 21 underwent a clinical examination. RESULTS: The cumulative reoperation rate was 35% (22 out of 63). Three patients were reoperated on because of recurrence of pelvic organ prolapse. Among the 63 patients initially operated, vaginal mesh exposure occurred in 16 (25%) during follow-up and 11 women (17%) needed a reintervention for vaginal mesh exposure. One patient was reoperated on for bladder mesh exposure. Among the 29 women who completed follow-up, the overall postoperative improvement rate was 93% after 18 years (PGI-I: 1-3). Mean overall satisfaction rate was 80 out of 100. Functional success rate was 76% (22 out of 29) and anatomical success rate was 62% (13 out of 21). The median score of the POP-DI-6 was 4.1 (IQR: 0-11) and the median score of the PFDI-20 was 30.7 (IQR: 13-60) in the 29 women who completed maximum follow-up. CONCLUSION: At very long-term follow-up, the recurrence rate of cystocele following polypropylene mesh placement by the vaginal route remained low and the satisfaction rate was high. However, we found high cumulative reoperation and mesh exposure rates.

Prospective ultrasonographic follow-up of transvaginal lightweight meshes: a 1-year multicenter study.

INTRODUCTION AND HYPOTHESIS: The use of new lightweight meshes in pelvic organ prolapse (POP) surgery may reduce complications related to mesh retraction (chronic pain, dyspareunia, and mesh exposure). The aim of this study was to investigate changes in the area and position of Uphold Lite™ mesh 6 weeks and 12 months after anterior and/or apical prolapse repair. METHODS: This observational prospective multicenter study included patients who had undergone transvaginal surgery for symptomatic POP-Q stage ≥ II anterior and/or apical compartment prolapse with placement of Uphold Lite mesh. The dimensions and position of the mesh were evaluated at 6 weeks and 12 months by ultrasonography. Correlations between ultrasonographic mesh characteristics and POP recurrence were analyzed. RESULTS: Fifty evaluable women with an average age of 66.8 years were included. No statistically significant difference in mesh area was found between week 6 and month 12 postoperatively, either at rest (1746.92 vs. 1574.48 mm2; p = 0.15) or on Valsalva (1568.81 vs. 1542.98 mm2; p = 0.65). The ROC-AUC of the distance between the mesh and the bladder neck (M-BN) at 6 weeks for predicting cystocele recurrence at 12 months was 0.764 (95% CI 0.573-0.955) at rest and 0.724 (95% CI 0.533-0.916) on Valsalva. An M-BN distance > 12.5 mm could predict cystocele recurrence at month 12 with a sensitivity of 80% and a specificity of 69%. CONCLUSIONS: Ultrasonographic measurements of the Uphold Lite™ mesh appear to remain stable between 6 weeks and 12 months postoperatively. M-BN distance correlates with cystocele recurrence. These results appear to confirm the value of ultrasound in mesh evaluation.

In Vivo Evaluation of the Efficacy and Safety of a Novel Degradable Polymeric Film for the Prevention of Intrauterine Adhesions.

STUDY OBJECTIVE: To study the safety of a degradable polymeric film (DPF) and its efficacy on reducing the risk of intrauterine-adhesion (IUA) formation in a rat model. DESIGN: A series of case-control studies relying on random allocation, where feasible. SETTING: University and good practice animal laboratories. ANIMALS: The animal models comprised female and male Oncins France Strain A and female Wistar rats. INTERVENTION(S) AND MEASUREMENTS: The Oncins France Strain A rats were used for in vivo evaluation of the impact of the DPF on endometrial thickness and its effect on fertility. For in vivo evaluation of the biologic response, 40 Wistar rats were randomly allocated to intervention and control groups, with matched sampling time after surgery. Finally, for the in vivo evaluation of the DPF's efficacy on IUA prevention, a total of 24 Wistar rats were divided into 3 groups: 1 treated with the DPF, 1 treated with hyaluronic acid gel, and a sham group. MAIN RESULTS: The DPF did not have a significant impact on endometrial thickness, and there were no significant differences in the number of conceived or prematurely terminated pregnancies, confirming its noninferiority to no treatment. The DPF did not induce irritation at 5 days and 28 days. Finally, the DPF significantly reduced the likelihood of complete IUA formation compared with hyaluronic acid gel- and sham-implanted animals, where only 27% of the animals had their uterine cavity obliterated compared with 80% and 100%, respectively. CONCLUSION: The DPF is a safe film that is effective in preventing IUA formation after intrauterine curettage in rats.

Increased incidence of cancer in the follow-up of obstetric antiphospholipid syndrome within the NOH-APS cohort.

Malignancies can be associated with positive antiphospholipid antibodies but the incidence of cancer among women with the purely obstetric form of antiphospholipid syndrome (APS) is currently unknown. Our aim was to investigate the comparative incidence of cancers in women with a history of obstetric APS within a referral university hospital-based cohort (NOH-APS cohort). We performed a 17-year observational study of 1,592 non-thrombotic women with three consecutive spontaneous abortions before the 10th week of gestation or one fetal death at or beyond the 10th week of gestation. We compared the incidence of cancer diagnosis during follow-up among the cohort of women positive for antiphospholipid antibodies (n=517), the cohort of women carrying the F5 rs6025 or F2 rs1799963 polymorphism (n=279) and a cohort of women with negative thrombophilia screening results (n=796). The annualized rate of cancer was 0.300% (0.20%-0.44%) for women with obstetric APS and their cancer risk was substantially higher than that of women with negative thrombophilia screening [adjusted hazard ratio (aHR) 2.483; 95% confidence interval (CI) 1.27-4.85]. The computed standardized incidence ratio for women with obstetric APS was 2.89; 95% CI: 1.89-4.23. Among antiphospholipid antibodies, lupus anticoagulant was associated with incident cancers (aHR 2.608; 95% CI: 1.091-6.236). Our cohort study shows that the risk of cancer is substantially higher in women with a history of obstetric APS than in the general population, and in women with a similar initial clinical history but negative for antiphospholipid antibodies.

Risk of new-onset urinary incontinence 3 and 12 months after vaginal or cesarean delivery of twins: Part I.

INTRODUCTION AND HYPOTHESIS: Our purpose was to compare the prevalence of urinary incontinence (UI) 3 and 12 months after vaginal vs cesarean delivery of twins after 34 weeks of gestation. METHODS: This was a multicenter prospective cohort study conducted at 172 French maternity units and included 2812 primiparous women with twins with no prior history of UI. Participants were enrolled at the time of delivery and followed up to 12 months postpartum. The primary outcome was the prevalence of UI, both stress and urge, 3 months postpartum, based on the patient reporting any frequency of urine leakage to the first question of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). The Pelvic Floor Distress Inventory - Short Form 20 (PFDI-20), Pelvic Floor Impact Questionnaire - Short Form 7 (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Medical Outcome Study Short Form-12 (SF-12) were also used. RESULTS: The ICIQ-SF was completed by 1155 (39.8%) and 800 (27.5%) women, respectively, at 3 and 12 months postpartum; 556 (48%) had delivered vaginally and 599 (52%) by cesarean section. The prevalence of UI at 3 months was 26% overall and was significantly higher in the vaginal delivery group at both 3 months (35% vs 17% in the cesarean group, p < 0.0001) and 12 months postpartum (38% vs 24%, p < 0.0001). UI was predominantly stress or mixed. The risk factors for UI at 3 months, determined by multivariate modeling, were vaginal delivery [odds ratio (OR) 3.073, 95% confidence interval (CI) 2.3-4.105, p < 0.0001) and body mass index >25 in early pregnancy (OR 1.620, 95% CI 1.188-2.209, p = 0.0023). CONCLUSIONS: Vaginal delivery is a risk factor for UI at 3 months after twin birth.

Impact of mode of delivery of twins on the pelvic floor 3 and 12 months post-partum-part II.

INTRODUCTION AND HYPOTHESIS: To compare the impact of vaginal delivery (VD) versus cesarean section (CS) on the pelvic floor in twin primiparae at 3 and 12 months postpartum. METHODS: This comparative multicenter prospective cohort from a large French national cohort study consisted of primiparas who gave birth to live twins after 34 weeks of gestation. The primary end point was the postnatal urinary incontinence rate 3 months postpartum. The secondary end points were the pelvic floor dysfunction (PFD) at 3 and 12 months based on PFDI-20, PFIQ-7, PISQ-12, and SF-12 responses. RESULTS: A total of 2812 patients in 172 French maternity units were recruited between February 2014 and March 2015: 1076 (38%) responded at 3 and 12 months (61% at 3 months); 1155 were analyzed at 3 months (556 VD and 599 CS) and 800 at 12 months (394 VD and 406 CS). VD was associated with more symptoms at 3 months [median PFDI-20 score 25/300 (8-50) vs. 17/300 (4-36) after CS; p < 0.0001]. Vaginal bulge was more frequently reported after VD (9 vs. 4%; p = 0.0015). Abdnormal PFD-related quality-of-life scores (scores > 0) were more frequent after VD at 3 months (58 vs. 42%; p < 0.0001) and 12 months (57 vs. 43%; p = 0.0020), indicating greater discomfort. However, SF-12 scores were higher after VD [56 (53-59) vs. 55 (51-58)] at 12 months, indicating better general quality of life. CONCLUSIONS: Mode of delivery is significantly associated with pelvic organ prolapse symptoms 3 months postpartum, which regress by 12 months, probably because of the known spontaneous postnatal improvement of PFDs.

Obstetric antiphospholipid syndrome: early variations of angiogenic factors are associated with adverse outcomes.

The prognostic value of angiogenic factors in newly pregnant women with obstetric antiphospholipid syndrome (oAPS) has not been documented. We observed 513 oAPS who experienced three consecutive spontaneous abortions before the 10th week of gestation or one fetal loss at or beyond the 10th week. We assessed the plasma concentrations of the proangiogenic factor placenta growth factor (PIGF) and of the antiangiogenic factor soluble fms-like tyrosine kinase-1 on the eve and on the 4th day of the low-molecular weight heparin-low-dose aspirin treatment. Placenta growth factor and fms-like tyrosine kinase-1 plasma concentrations showed marked increases. Treatment-associated variations of PIGF and of soluble fms-like tyrosine kinase-1 were antagonist risk factors for placenta-mediated complications (PMC) and for severe PMC, for fetal death, stillbirth and neonatal death. The ratio between PIGF increase and soluble fms-like tyrosine kinase-1 was a summary variable whose best cut-off values (1.944.10-2) had high negative predictive values for PMC (0.918) and may be used to help rule out the development of PMC in evolutive pregnancies after 19 completed weeks. The early variations of PIGF and soluble fms-like tyrosine kinase-1 concentrations in newly pregnant oAPS may help to detect patients at low risk of PMC. (clinicaltrials.gov identifier: 02855047).

Treatment of neovaginal prolapse: case report and systematic review of the literature.

INTRODUCTION AND HYPOTHESIS: Neovaginal prolapse (NP) is a rare event as few cases have been reported in the literature. Its management is complex and depends on the initial pathology, the vaginoplasty technique and the patient's history. We present a review the literature on this rare event. METHODS: We describe the case of a 72-year-old woman who presented with NP 1 year after pelvic exenteration and radiotherapy for recurrent cervical carcinoma associated with vaginal reconstruction by shaped-tube omentoplasty. She had undergone two previous surgical procedures (posterior sacrospinous ligament suspension and partial colpocleisis), but NP recurred each time within a few months. We performed an anterior approach to the sacrospinous ligament and inserted a mesh under the anterior wall of the neovagina, with the two mesh arms driven through the sacrospinous ligament in a tension-free manner (Uphold Lite® system). The MEDLINE, Cochrane Library, ClinicalTrials and OpenGrey databases were systematically searched for literature on the management of NP following bowel vaginoplasty, mechanical dilatation, graciloplasty, omentoplasty, rectus abdominis myocutaneous flap and the Davydov procedure. RESULTS: The postoperative course in the patient whose case is described was uneventful and after 1 year of follow-up, the anatomical results and patient satisfaction were good. The systematic search of the databases revealed several studies on the treatment of NP using abdominal and vaginal approaches, and these are reviewed. CONCLUSIONS: Overall, sacrocolpopexy would appear to be a good option for the treatment of prolapse after bowel vaginoplasty, but too few cases have been reported to establish this technique as the standard management of NP.

Changes in pelvic organ prolapse mesh mechanical properties following implantation in rats.

BACKGROUND: Pelvic organ prolapse (POP) is a multifactorial disease that manifests as the herniation of the pelvic organs into the vagina. Surgical methods for prolapse repair involve the use of a synthetic polypropylene mesh. The use of this mesh has led to significantly higher anatomical success rates compared with native tissue repairs, and therefore, despite recent warnings by the Food and Drug Administration regarding the use of vaginal mesh, the number of POP mesh surgeries has increased over the last few years. However, mesh implantation is associated with higher postsurgery complications, including pain and erosion, with higher consecutive rates of reoperation when placed vaginally. Little is known on how the mechanical properties of the implanted mesh itself change in vivo. It is assumed that the mechanical properties of these meshes remain unchanged, with any differences in mechanical properties of the formed mesh-tissue complex attributed to the attached tissue alone. It is likely that any changes in mesh mechanical properties that do occur in vivo will have an impact on the biomechanical properties of the formed mesh-tissue complex. OBJECTIVE: The objective of the study was to assess changes in the multiaxial mechanical properties of synthetic clinical prolapse meshes implanted abdominally for up to 90 days, using a rat model. Another objective of the study was to assess the biomechanical properties of the formed mesh-tissue complex following implantation. STUDY DESIGN: Three nondegradable polypropylene clinical synthetic mesh types for prolapse repair (Gynemesh PS, Polyform Lite, and Restorelle) and a partially degradable polypropylene/polyglecaprone mesh (UltraPro) were mechanically assessed before and after implantation (n = 5/ mesh type) in Sprague Dawley rats for 30 (Gynemesh PS, Polyform Lite, and Restorelle) and 90 (UltraPro and Polyform Lite) days. Stiffness and permanent extension following cyclic loading, and breaking load, of the preimplanted mesh types, explanted mesh-tissue complexes, and explanted meshes were assessed using a multi-axial (ball-burst) method. RESULTS: The 4 clinical meshes varied from each other in weight, thickness, porosity, and pore size and showed significant differences in stiffness and breaking load before implantation. Following 30 days of implantation, the mechanical properties of some mesh types altered, with significant decreases in mesh stiffness and breaking load, and increased permanent extension. After 90 days these changes were more obvious, with significant decreases in stiffness and breaking load and increased permanent extension. Similar biomechanical properties of formed mesh-tissue complexes were observed for mesh types of different preimplant stiffness and structure after 90 days implantation. CONCLUSION: This is the first study to report on intrinsic changes in the mechanical properties of implanted meshes and how these changes have an impact on the estimated tissue contribution of the formed mesh-tissue complex. Decreased mesh stiffness, strength, and increased permanent extension following 90 days of implantation increase the biomechanical contribution of the attached tissue of the formed mesh-tissue complex more than previously thought. This needs to be considered when using meshes for prolapse repair.

Methods of pushing during vaginal delivery and pelvic floor and perineal outcomes: a review.

PURPOSE OF REVIEW: Over the past 20 years, several randomized studies have compared Valsalva and spontaneous pushing techniques during vaginal delivery. This review summarizes current medical knowledge concerning their maternal and fetal consequences, focusing on pelvic and perineal outcomes. RECENT FINDINGS: We selected nine randomized controlled trials comparing Valsalva and spontaneous pushing, and a secondary analysis of a randomized controlled trial comparing different methods of perineal protection. Two trials showed that spontaneous pushing reduces the risk of perineal tears, but no firm conclusions can be drawn given the heterogeneity and inconsistent results of these studies. Conflicting results have been reported regarding the duration of the second stage of labor. Pushing technique does not seem to affect episiotomy, instrumental delivery or cesarean rates. Maternal satisfaction seems to be better after spontaneous pushing. Spontaneous pushing appears to have no adverse effects on neonatal well being, and one study showed a significant improvement in prenatal fetal parameters during the expulsive phase. SUMMARY: Valsalva and spontaneous pushing techniques currently appear comparable in terms of duration, pelvic floor, perineal, and neonatal outcomes. In the absence of strong evidence in favor of either technique, the decision should be guided by patient preference and the clinical situation. Additional, well-designed randomized controlled trials are required.

Utero-vaginal suspension using bilateral vaginal anterior sacrospinous fixation with mesh: intermediate results of a cohort study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a major burden for the public health system, affecting up to 30 % of all women. One mesh kit has been introduced for pelvic organ prolapse surgery that can be inserted via a single anterior incision with the mesh arms driven through the sacrospinous ligament in a tension-free manner. The aim of this study was to describe the medium-term results of this vaginal mesh kit procedure for the combined treatment of the anterior vaginal wall and vault prolapse. METHODS: This is a longitudinal case series of patients undergoing an anterior mesh operation between 2009 and 2013. All patients presenting with symptomatic stage II prolapse or higher were included when a minimum follow-up of 12 months was achieved. A structured interview and clinical examination were performed pre- and postoperatively. RESULTS: One hundred and eighteen consecutive patients were operated with the Uphold® system during the study period. Three patients did not complete the 12-month follow-up and were excluded from the analysis, leaving 115 patients. Anatomical success at a mean follow-up of 23 months was 93 %, with a patient satisfaction rate of 95 %. Four patients (8 %) experienced de novo dyspareunia related to the mesh. The reoperation rate for mesh-related complications was 3.4 %; no patients were re-operated for POP recurrence. CONCLUSIONS: The subjective and objective cure rates were high and the mesh-related re-operation rate was 3 % in the medium term, suggesting that this surgical technique may be an option for women requiring anterior and apical prolapse repair.

Success factors for Bakri™ balloon usage secondary to uterine atony: a retrospective, multicentre study.

BACKGROUND: Post-partum haemorrhage (PPH) is one of the major obstetric complications and remains a cause of avoidable maternal mortality and morbidity. AIMS: The aims of this study were to assess the success and practicability of a Bakri™ balloon intrauterine tamponade for PPH and evaluate the predictive factors for success. MATERIALS AND METHODS: Women who received the Bakri™ balloon secondary to uterine atony and subsequent failure of routine drug treatment were identified at 6 hospital sites. Demographic, obstetric and specific factors in regard to the Bakri™ balloon use were recorded. Factors predictive of Bakri™ balloon success were evaluated. RESULTS: Intrauterine Bakri™ balloon tamponade was used in 36 women with uterine atony of which 28 received the balloon treatment after vaginal delivery: more than 50% of women (16/28) presented with PPH with blood loss > 1000 mL (mean blood loss: 1130 mL). Two balloon insertions failures were identified. Bakri balloon success was 100% for women with bleeding < 1000 mL. Twenty-five women (69%) did not require invasive treatment; seven (19%) required arterial embolisation and four (11%) surgical management. No short-term complication was observed after balloon insertion. CONCLUSION: The use of the Bakri™ balloon method, if undertaken early, is effective for the management of PPH with uterine atony (100% success compared to 69% overall success rate). Intrauterine balloon tamponade should included in PPH management guidelines.

Transischioanal trans-sacrospinous ligament rectocele repair with polypropylene mesh: a prospective study with assessment of rectoanal function.

INTRODUCTION AND HYPOTHESIS: Despite good anatomical outcomes of pelvic organ prolapse (POP) repair by the vaginal route using synthetic mesh, complications limit their use. Clinical data are needed to generalize prolapse mesh repair by the vaginal route. The current study aims to evaluate midterm rectoanal function and clinical outcomes after transischioanal rectocele repair using a medium weight polypropylene mesh. METHODS: Between March 2003 and June 2004, 230 patients with stage II-IV anterior and/or posterior POP were included in a prospective multicenter study. The current study is based on the analysis of the 116 patients who underwent a rectocele repair via the infracoccygeal route through the sacrospinous ligament. Anatomical cure was defined when rectocele was at stage

[Objective assessment of symptoms and informing patients of surgical risks]. / Evaluation objective des symptomes et information des patientes.

Genital prolapse is a functional pathology presenting with numerous urinary, genito-sexual, and anorectal symptoms. These symptoms are responsible for an alteration of the quality of life, sometimes associated to a real anxiety-depressive syndrome. Because of these complex intricacies, the management of these disorders became multidisciplinary. Tools to measure the impact of prolapse symptoms on the quality of life became a necessity. Such instruments should allow a correlation of the functional symptomatology at the anatomic stage, raise a surgical indication based on the functional disturbance and evaluate the effectiveness and tolerance of the various therapeutic procedures. Two validated self-questionnaires in French (short versions of the Pelvic Floor Distress Inventory [PFDI-20] and the Pelvic Floor Impact Questionnaire [PFIQ-7]) are presently available. Moreover, the physician has the legal obligation to provide detailed presurgical information on frequent and severe hazards, expected benefits, functional consequences, therapeutic alternatives and the consequences of nonintervention. Before surgery takes place, the surgical approach, the benefit of using synthetic prostheses, the possibility of uterine and/or ovarian conservation, and some risky conditions such as smoking, obesity and estrogen deficiency should be discussed.

[Photobiomodulation and vulvovaginal disorders after anticancer treatments]. / Photobiomodulation et troubles vulvovaginaux après traitements anticancéreux.

Anticancer treatments induce vulvovaginal complications that alter the quality of life and sexuality of patients. New technologies, such as photobiomodulation, could address this problem, for which few effective therapeutic solutions exist. The objective of this study was to describe the characteristics of patients seeking treatment and to observe the effects of photobiomodulation. This is a prospective cohort of patients treated for cancer, in failure of first-line medical treatment, managed at the University Hospital of Nîmes. The history, symptoms and impact of the disorders on their quality of life were collected. At follow-up, improvement was assessed using the PGI-I and FSFI questionnaires. Twenty-eight patients were treated. They were all menopausal, half of them after anticancer treatments [chemotherapy (78%), radiotherapy (36%), hormone therapy (36%)]. The main symptom reported was vaginal dryness (72%). Seventy-one percent of patients (n=20) felt that their daily life was affected≥8/10. All patients had sexual dysfunction. Twenty-two patients received at least 6 sessions of photobiomodulation. Seventy-two percent (n=18) of patients felt better or much better after treatment (PGI-I≤2). The median improvement estimated by the patients was 65% (Q1=50%; Q3=72.5%). There was also a significant clinical improvement. No serious adverse events were reported. Due to the small number of patients in a heterogeneous population with no control group, we cannot extrapolate our results. However, the objective was to assess the status of these pathologies and the contribution of photobiomodulation in patients who have failed first-line treatment; and these results are encouraging.

Effects of a physical activity and endometriosis-based education program delivered by videoconference on endometriosis symptoms: the CRESCENDO program (inCRease physical Exercise and Sport to Combat ENDOmetriosis) protocol study.

BACKGROUND: Endometriosis is a chronic disease characterized by growth of endometrial tissue outside the uterine cavity which could affect 200 million women (The term "woman" is used for convenience. Individuals gendered as man or as nonbinary can also suffer from this disease) worldwide. One of the most common symptoms of endometriosis is pelvic chronic pain associated with fatigue. This pain can cause psychological distress and interpersonal difficulties. As for several chronic diseases, adapted physical activity could help to manage the physical and psychological symptoms. The present study will investigate the effects of a videoconference-based adapted physical activity combined with endometriosis-based education program on quality of life, pain, fatigue, and other psychological symptoms and on physical activity. METHODS: This multicentric randomized-controlled trial will propose to 200 patients with endometriosis to be part of a trial which includes a 6-month program with 45 min to more than 120 min a week of adapted physical activity and/or 12 sessions of endometriosis-based education program. Effects of the program will be compared to a control group in which patients will be placed on a waiting list. All participants will be followed up 3 and 6 months after the intervention. None of the participants will be blind to the allocated trial arm. The primary outcome measure will be quality of life. Secondary outcomes will include endometriosis-related perceived pain, fatigue, physical activity, and also self-image, stereotypes, motivational variables, perceived support, kinesiophobia, basic psychological need related to physical activity, and physical activity barriers. General linear models and multilevel models will be performed. Predictor, moderator, and mediator variables will be investigated. DISCUSSION: This study is one of the first trials to test the effects of a combined adapted physical activity and education program for improving endometriosis symptoms and physical activity. The results will help to improve care for patients with endometriosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05831735 . Date of registration: April 25, 2023.

Cystocele repair by vaginal route: comparison of three different surgical techniques of mesh placement.

INTRODUCTION AND HYPOTHESIS: Different techniques of mesh placement for cystocele repair are known. Our goal was to compare anatomical and functional outcomes of three different techniques of mesh placement over a 3-year follow-up. METHODS: Between March 2003 and June 2004, 230 patients (stage 2-4 pelvic organ prolapse (POP)) were included in a prospective study. For cystocele repair, mesh was implanted either with two arms into the retropubic space (RP) or with two to four arms into the obturator foramen (TO), or fixed to the arcus tendineous fascia pelvis (FG). RESULTS: Patients' distribution is as follows: 142 TO, 32 RP, and 31 FG. Anatomical success (cystocele < stage 2 in the POP staging system) was clearly poorer after the retropubic free technique, with success rates of 69% (RP), 90.1% (TO), and 96.6% (FG) (p = 0.004). POP distress inventory (p < 0.005) and POP impact questionnaire scores were both significantly poorer after RP. CONCLUSIONS: RP technique is less effective than TO and FG techniques.