Comparison of first versus second line sacrocolpopexies in terms of morbidity and mid-term efficacy.

To compare pelvic organ prolapse (POP) recurrence and morbidity between first and second line sacrocolpopexies. We conducted a retrospective chart review of all laparoscopic or robotic sacrocolpopexies for POP-Q stage ≥ 2, with or without a history of previous prolapse repair, performed with a similar technique between January 2012 and June 2019 in 3 European Gynecologic Surgery Departments. Patients were separated into two groups: first line sacrocolpopexy (FLS) and second line sacrocolpopexy (SLS). Each patient from the SLS group was age-matched with a patient from the FLS group. The primary outcome measure was reoperation procedures for recurrent POP defined as a symptomatic POP-Q stage ≥ 2 POP in at least one vaginal compartment. Secondary outcomes included operative time, intraoperative organ trauma, intraoperative blood loss, postoperative POP recurrence (operated on or not), global reoperation and mesh-related complications. During this period, 332 patients were included. After age-matching, 170 patients were analyzed: 85 patients in the FLS and SLS groups, respectively. After a mean follow-up of 3 years, there was no statistically significant difference between the two groups in terms of recurrent POP (9.4% versus 10.6%, p = 0.7), recurrent POP reoperation (3.5% versus 5.9% p = 0.7), mesh-related reoperation (0% versus 2.4%, p = 0.5), global reoperation (3.5 versus 8.2%, p = 0.3), operative time (198 ± 67 min versus 193 ± 60 min, p = 0.5), intraoperative complications such as organ injury (4.7% versus 7.1%, p = 0.7) and blood loss > 500 mL (2.4% versus 0%, p = 0.5). Patients who underwent a first or a second line sacrocolpopexy seemed to have similar rates of prolapse recurrence and complications.

Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry.

OBJECTIVE: To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair. DESIGN: Prospective cohort study using a registry. SETTING: Nineteen French surgical centres. POPULATION: A total of 2309 women participated between 2017 and 2019. METHODS: A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups. MAIN OUTCOME MEASURES: Serious complications and subsequent reoperations for POP recurrence. RESULTS: The median follow-up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43-6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45-4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13-0.39) and sacropexy (wHR 0.29, 95% CI 0.18-0.47) groups. CONCLUSIONS: Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making. TWEETABLE ABSTRACT: Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair.

Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial.

OBJECTIVE: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years. DESIGN: Extended follow up of a randomised trial. SETTING: Eleven centres. POPULATION: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery. METHODS: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM). MAIN OUTCOME MEASURES: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications. RESULTS: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049)). CONCLUSIONS: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).

[Trends in the use of midurethral slings after the new legislation: A nationwide survey]. / Évolution des pratiques après l'arrêté encadrant les bandelettes sous-urétrales : résultats d'une enquête nationale.

INTRODUCTION: The French Department of Health published on October 23, 2020 a decree governing acts associated with mid-urethral sling (MUS) operations. The aim of this study was to evaluate the changes in practice following this new legislation. METHODS: A cross-sectional study was carried out among French urologists and gynecologists using an online survey to collect changes in practices since the publication of the decree. RESULTS: From January to February 2021, 436 surgeons participated in the survey. Among these surgeons, 87% were aware of the new legislation and 56% of them considered the decree as useless. The order resulted in an increase in working time in 81% of cases. Among these surgeons, 66% of the surgeons worked in tertiary referral centers for the management of incontinence, of which 55% had a multidisciplinary meeting in urogynecology. Among the surgeons, 31% considered this meeting to be useful but 80% considered that it did not lead to any change in surgical indications, even though 33% of complications of BSU were discussed there. In conclusion, 61% of surgeons felt more reluctant to schedule a BSU placement with this new legislation. CONCLUSION: The majority of questioned surgeons considered the decree as useless. It generated few changes in practices which already respected the law on information, consultation, consent, experience and training. Most urologists and gynecologists are more reluctant to offer MUS after this new legislation. LEVEL OF EVIDENCE: 4.

Evaluating the morbidity and long-term efficacy of laparoscopic sacrocolpopexy with and without robotic assistance for pelvic organ prolapse.

OBJECTIVE: The aim of our study was to compare the morbidity and long-term efficacy after laparoscopic sacrocolpopexy with and without robotic assistance. METHODS: We conducted a retrospective chart review of all laparoscopic or robotic sacrocolpopexies for POP-Q stage 2-4 vaginal prolapse performed between September 2015 and October 2018 in 2 Gynecologic Surgery Departments of France. Patients were separated into two groups: a laparoscopic sacrocolpopexy group (LS) and a robotic-assisted sacrocolpopexy group (RAS). The primary outcome measure was reoperation procedures for recurrent pelvic organ prolapse (POP). RESULTS: Two hundred and fourteen patients were included, 160 patients (75%) in the LS group and 54 patients (25%) in the RAS group. After a mean follow-up of 32.8 months, reoperation rate for recurrent POP and the recurrent POP rate were greater in the RAS group (9.2% versus 1.2%, p = 0.01 and 25.9% versus 7.5%, p = 0.0003, respectively). No significant difference was found in terms of immediate intraoperative (3.1% versus 1.8%, p = 1) and postoperative complications (1.9% versus 1.8%, p = 1). On comparing the 2 groups by bivariate analysis, RAS significantly increased the odds of reoperation for POP recurrence (OR = 7.8 CI 95% [1.5-41.6], p = 0.02) and the odds of global reoperation (OR = 3.8 CI 95% [1.4-10.4], p = 0.0095). Similarly, multivariate logistic analysis showed that RAS increased the risks of global reoperation (OR = 3.8 CI 95% [1.3-10.6], p = 0.01) after controlling high-grade prolapse. CONCLUSION: Robotic sacrocolpopexy does not appear to give long-term clinical benefits. Recurrent POP and reoperation procedures seem to be more frequent in case of robotic-assisted surgery.

Symptom related to Essure® and evolution after removal: Outcomes of retrospective cohort.

INTRODUCTION: The number of requests for Essure removal has grown continually over recent years. The objective is to describe the symptoms reported after Essure sterilization, methods of removal and results. MATERIAL AND METHODS: Retrospective and single-centre cohort (Regional university hospital of Lille, France) was conducted. All women, having consulted from December 2016 to February 2019 for symptoms related to Essure insertion, were included. All the symptoms were noted. A second group was created that included patients who underwent Essure removal to evaluate the benefits of surgery on these symptoms. RESULTS: The study included 98 patients. Most frequent symptoms were musculoskeletal pain (75 %), asthenia (63 %) and pelvic pain (55 %). Fifty-nine patients (60 %) underwent surgery. Surgery appeared beneficial with reduction of symptoms in 60 % of these patients, complete resolution in 33 % and no reduction of symptoms in 7%. Many symptoms were relieved by surgery with an overall decline of 96 % in menorrhagia, 94 % in metrorrhagia and 93 % in dyspareunia. However, other symptoms were not relieved by surgery like 100 % of sleep disorders, 70 % of abdominal pain cases and 57 % of memory impairment cases. CONCLUSION: Symptoms related to Essure insertion are numerous. Although surgery appears beneficial, some adverse effects remain. Therefore, a preoperative aetiologic assessment and information about risk of surgery failure are important.

Easy way to perform a labia minora reduction.

BACKGROUND: Labia minora reduction is a surgery in the rise. Surgeons are left with a large choice of described techniques yet there is a paucity of visual data to guide surgeons through this procedure. Also, many gynecologic surgeons are reluctant to perform this operation emphasizing potential complications. TECHNIQUE: We present a step by step visual support of a wedge resection technique. EXPERIENCE: This technique of labia minora reduction is safe and carries a great satisfaction rate among patients. CONCLUSION: We believe that a visual description of a simple and quick technique will help standardized patient care and achieve good outcomes.

Feasibility of vaginal mesh for anterior vaginal wall prolapse in an ambulatory setting: A retrospective case series.

INTRODUCTION: Vaginal mesh has been proven to be an effective aid in the treatment of cystocele. Could an ambulatory approach be feasible for the Uphold Lite®-mesh? HYPOTHESIS: We investigate the feasibility of an ambulatory approach of Uphold Lite® insertion in a well-selected population. Risk factors for a non-successful ambulatory approach are identified. METHODOLOGY: We conducted a retrospective case series of 236 women who underwent Uphold Lite® vaginal mesh insertion for the treatment of pelvic organ prolapse at our center. Indications for surgery were symptomatic anterior and/or apical prolapse, stages POPQ≥2. We compared women having an ambulatory approach, to those having a one day hospitalization planned but needed to stay. Comparisons between percentages were calculated using the chi-square or Fisher's exact test, depending on the number of women in each group. The mean comparisons were performed using the Student t-test, and the median test comparisons by the Kruskal-Wallis test. A difference was considered significant if p<0.05. RESULTS: The most common reason for staying (85.7% of all ambulatory failures) after Uphold® surgery is the presence of an elevated post void residual. This complication was more found in the following: surgery in the afternoon, use of high-dose morphinics in general anesthesia, and in women with a higher parity. CONCLUSIONS: Our study shows that Uphold® surgery in a one-day setting is feasible and safe. Women desiring this approach should be counselled on the 42.6% risk of one-day failure though, mostly due to non-validation of a post void residual. General anesthesia with high-dose morphinics, a higher parity, and surgery in the afternoon are risk factors for failure of an ambulatory protocol.

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

OBJECTIVE: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse. DESIGN: Prospective longitudinal cohort study using a surgical registry. SETTING: Thirteen public hospitals in France. POPULATION: A cohort of 1873 women undergoing surgery between February 2017 and August 2018. METHODS: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems. MAIN OUTCOME MEASURES: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death. RESULTS: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh. CONCLUSIONS: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors. TWEETABLE ABSTRACT: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.

Evolution of the mechanical properties of a medical device regarding implantation time.

BACKGROUND: Our study aimed at understanding the influence of healing time on the mechanical properties of meshes used in pelvic organ prolapse, once implanted in an animal model using the rat. METHODS: A standard polypropylene mesh was implanted in 42 rats in order to evaluate the mechanical properties of the implanted mesh. Explantation occurred at 1, 2, 3, 4 and 5 months and mechanical tests were performed. Each sample was mechanically evaluated by a uniaxial tensile test with a machine (BIOTENS). Biological tissues presented a nonlinear relation between stress and strain so it could be modeled by the 2 parameters C0 and C1 of a second-order Mooney-Rivlin law. RESULTS: The rigidity in small deformation might not be affected by healing time or the presence of the synthetic implant. On the contrary, changes seemed to occur on the stiffness in large deformation (C1). The stiffness with the mesh composite changed with healing time. The "two-month implantation" rat group was significantly more rigid than the two control groups (pcontrol/2months = 0,04 and pplacebo/2months = 0,04). The 2- and 3-month healing groups were significantly more rigid than the 1-month healing group (p1/2months = 0,01 and p1/3months = 0,003). After 2 months, the mechanical properties seemed to stabilize (p2/3months = 0,44, p2/5months = 0,16 et p3/5months = 0,3). CONCLUSION: In order to evaluate the mechanical properties of an implanted mesh, the optimal time for explantation seems to be 2 months. Once this period is over, a more physiological mesh will be developed in order to be similar to native vaginal tissue once implanted and colonized by scar tissue.

Disappearance of a myoma after pregnancy in a 38 years old patient, treated by ulipristal acetate without success before getting pregnant.

Uterine fibroids are the most common form of benign gynaecological tumors in women of childbearing age Piecak et al. (2017) [1]. These uterine fibroids can be responsible for abnormal uterine bleeding, pelvic pain, pelvic pressure and infertility Pritts et al. (2009), Ali and Al-Hendy (2017) [2,3]. Their treatment can be carried out according to several methods: medical treatment, uterine artery embolization or surgery (myomectomy or hysterectomy). Although surgery is the main option, there are medical treatments to reduce their size and decrease and control their symptoms. Ulipristal acetate (UPA) has been the first selective progesterone-receptor modulator approved for the preoperative and long-term treatment for uterine fibroids Ferrero et al. (2018) [4]. Here we present the case of a 38-years-old patient whose large fibroma (initially treated with UPA) totally disappeared after pregnancy.

[Antibiotic prophylaxis in urodynamics: Clinical practice guidelines using a formal consensus method]. / Antibioprophylaxie et bilan urodynamique : recommandations de bonne pratique par consensus formalisé.

OBJECTIVE: The aim of this work was to issue clinical practice guidelines on antibiotic prophylaxis in urodynamics (urodynamic studies, UDS). MATERIALS AND METHODS: Clinical practice guidelines were provided using a formal consensus method. Guidelines proposals were drew up by a multidisciplinary experts group (pilot group = steering group), then rated by a panel of 12 experts (rating group) using a formal consensus method, and then peer reviewed by a reviewing/reading group of experts (different from the rating group). RESULTS: Urine (bacterial) culture with antimicrobial susceptibility testing is recommended for all patients before UDS (strong agreement). In patients with no neurologic disease, the risk factors for tract urinary infection (UTI) after UDS are age > 70 years, recurrent UTI, and post-void residual volume > 100ml. In patients with neurologic disease, the risk factors for UTI after UDS are recurrent UTI, vesicoureteral reflux, and intermicturition pressure > 40cmH2O. If the urine culture is negative before UDS and there is no risk factor for UTI, antibiotic prophylaxis is not recommended (Strong agreement). If the urine culture is negative before UDS, but there are one or more risk factors for UTI, antibiotic prophylaxis is optional. If antibiotic prophylaxis is initiated, a single oral dose (3g) of fosfomycin-tromethamine two hours before UDS is recommended (Strong agreement). If there is bacterial colonization on UCB before UDS, antibiotic therapy is optional (Undecided). If prescribed, it should be adapted to the antimicrobial susceptibility of the identified bacterium or bacteria, started the day before and stopped after UDS (except for fosfomycin-tromethamine: a single dose the day before UDS is necessary and sufficient) (Strong agreement). In the event of UTI before UDS, the UTI should be treated and UDS postponed (Strong agreement). The proposed recommendations should not be changed for patients with a hip or knee replacement (Strong agreement). No antibiotic prophylaxis of bacterial endocarditis is necessary, including in high-risk patients with valvular heart disease (Strong agreement). CONCLUSION: These new guidelines should help to harmonize clinical practice and limit exposure to antibiotics. LEVEL OF EVIDENCE: 4.

Implementation of laparoscopy surgery training via simulation in a low-income country.

OBJECTIVE: The objective of this study was to evaluate laparoscopy training using pelvitrainers for gynaecological surgeons in a low-income country. METHODS: The study was carried out in Madagascar from April 2016 to January 2017. The participants were gynaecological surgeons who had not previously performed laparoscopy. Each surgeon was timed to evaluate the execution times of four proposed exercises, based on the fundamentals of laparoscopic surgery (FLS) programme's skills manual, as follows: exercise 1, involving a simple object transfer; exercises 2 and 3, comprising complex object transfers; and exercise 4, a precision cutting exercise. The 8-month training and evaluation programme was divided into different stages, and the four following evaluations were compared: a pretest (T0), assessment at the end of the first training (T1) and auto-evaluation at 2 months (T2) and 8 months (T3). RESULTS: Eight participants were included. The median time was significantly reduced (P<0.05) at each evaluation for exercises 1, 2 and 4 compared to the pretest. For exercise 3, there was no difference between T0 and T1 (P=0.07). After 8 months of training, all participants progressed in all exercises. CONCLUSION: Our study showed that it is possible and beneficial to develop a programme for teaching laparoscopic surgery in low-income countries before providing the necessary equipment.

Female pelvic anatomy: Are we there yet? Assessment of the knowledge of residents.

BACKGROUND: Anatomy is considered a keystone in medical education and pelvic anatomy comprehension is the groundwork of the understanding of birthing process and pelvic surgery. The objectives of this study were to assess the state of the knowledge in anatomy of ob/gyn residents. MATERIEL AND METHODS: The assessment of pelvic anatomy knowledge of 52 ob/gyn residents was performed in a cross-sectional analysis in Lille University Hospital in 2015. A survey was designed with educational and clinical objectives on pelvic anatomy to assess the resident's real level of knowledge. RESULTS: Ob/gyn residents were not satisfied with the learning of anatomy at the medical school with a global rate of 92% of unhappy residents. The global score in anatomy for the overall population was 6.67±0.46 (on 20 points). The eldest residents had a significant better global score than the youngest, 9.24±0.76 vs. 5.53±0.46 (P<0.0001). CONCLUSIONS: Ob/gyn residents should be educated to a specific teaching in anatomy throughout their residency program. Some strategies could improve the level of ob/gyn residents in anatomy and the survey showed the attractiveness of residents to modern medias, such as anatomy videos, compared to current historical anatomy lectures human cadaveric dissections or books.

Outpatient vaginal hysterectomy: Comparison of conventional suture ligature versus electrosurgical bipolar vessel sealing.

OBJECTIVE: The aim of our study was to evaluate the feasibility of vaginal hysterectomy in an ambulatory care system and the best way to perform it between conventional and bipolar vessel sealing system ligatures. PATIENTS AND METHODS: This was a prospective study of 32 patients with vaginal hysterectomy at Lille University Hospital between December 2013 and May 2015. Two surgical techniques were compared: conventional suture ligature (CSL) and electrosurgical bipolar vessel sealing (BVS). Patients stayed in classical hospitalization but were managed how if they were in an ambulatory unit to evaluate their capacity to come back home the same evening of the surgery. The evaluation of same-day discharge was based on Post Anesthetic Discharge Scoring System (PADSS) score?9/10 and Visual Analogic Scale (VAS) score?4/10. Other data collected were: operative time, uterus weight, peroperative bleeding, PADSS score at the 8th postoperative hour, VAS score at the 4th, 6th, 8th, 12th and 24th postoperative hours, the presence of postoperative nausea/vomiting and rehospitalization. RESULTS: In the BVS group, 93.8% of patients validated the combined score (PADSS+VAS) on the evening of the intervention against 50% of patients in the CSL group (P<0.05). Hundred percent of BVS group patients were discharged on the day after surgery against 87.5% in the CSL group. The VAS was significantly lower in the BVS group at the 8th (1.4), 12th (1.2) and 24th (1.3) postoperative hours. Operative time was significantly shorter in the BVS group. We found more events such as nausea/vomiting in the CSL group. CONCLUSION: Vaginal hysterectomy is feasible in an ambulatory care system most of times. By reducing postoperative pain, electrosurgical bipolar vessel sealing would promote outpatient hospitalization.