Serious complications and recurrences after retropubic vs transobturator midurethral sling procedures for 2682 patients in the VIGI-MESH register.

BACKGROUND: Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. OBJECTIVE: This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. STUDY DESIGN: This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. RESULTS: A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. CONCLUSION: The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.

Anterior/Apical single incision mesh (Elevate™): Surgical experience, anatomical and functional results, and long-term complications.

OBJECTIVE: Pelvic organ prolapse is a common condition among post-menopausal women, and surgery is often the standard treatment proposed. Native tissue vaginal surgery is burdened by a high rate of recurrence, and mesh vaginal surgery has become current practice. The purpose of this study was to evaluate the safety and the effectiveness of the vaginal kit Anterior/Apical single incision mesh Elevate™ for the correction of anterior and apical compartment prolapse. STUDY DESIGN: Data of patients with symptomatic anterior vaginal prolapse stage ≥ II, receiving mesh repair with the Anterior/Apical Elevate single incision system between January 2010 and January 2015 were retrieved. Prolapse was classified according to the POP-Q system. The main outcome measure was anatomical success, while subjective and safety outcomes were secondary outcomes. RESULTS: Anatomical success rate was 87.2 % for anterior compartment prolapse and 84.6 % for combined anterior and apical prolapse, while overall functional success rate was 96.2 % after a median follow-up of 33.6 months. The most frequent short-term complications were urinary bladder injury (3.0 %) and transient urinary retention (6.9 %). The most common long-term complications were de novo or persistent symptomatic stress urinary incontinence (10.8 %) and vaginal mesh extrusion (3.8 %). CONCLUSION: Mesh vaginal surgery with Anterior/Apical single incision mesh Elevate™ is a well-tolerated procedure with a very high anatomical and functional success rate. Short and long-term complications rate seem to be acceptable, and in most of cases, solvable. Further studies are needed to confirm our promising data.

Comparison of different surgical techniques for pelvic floor repair in elderly women: a multi-institutional study.

PURPOSE: The prevalence of pelvic organ prolapse (POP) is increasing. The number of women aged 70-80 years requiring surgical management for POP is also increasing. The purpose of this study was to compare the complications associated with three pelvic organ prolapse repair methods, sacrocolpopexy (SCP), native tissue repair (NTR), and vaginal mesh repair (VMR), in women aged 70-80 years. METHODS: We performed a multi-institutional retrospective analysis of 213 women who underwent POP surgical repairs between December 2012 and December 2017. Treatment-related complications were classified using the ClavienDindo grading system and compared among the three groups. Perioperative data, anatomical success rates, patient satisfaction, and postoperative complication data were collected during the follow-up period, which lasted up to 12 months. RESULTS: Of 213 patients, 70 (33%) underwent SCP, 85 (40%) underwent NTR, and 58 (28%) underwent VMR. By postoperative day 30, the all-inclusive complication rate was lower in the SCP group than in the NTR or VMR group; however, there was no between-group difference in complication grade. The VMR group underwent fewer concomitant hysterectomies than the other groups, and operative time was the longest for SCP. Overall, recovery time, anatomical success rate, and patient satisfaction were comparable for all three repairs. CONCLUSIONS: All three surgical techniques were equivalent in patient satisfaction, anatomical success rate, and complication rate. SCP should be recommended to elderly women who meet criteria for prolonged general anesthesia, as it was associated with fewer perioperative complications than NTR and VMR.

Descending Perineum Associated With Pelvic Organ Prolapse Treated by Sacral Colpoperineopexy and Retrorectal Mesh Fixation: Preliminary Results.

Introduction and hypothesis: Descending Perineum Syndrome (DPS) is a coloproctologic disease and the best treatment for it is yet to be defined. DPS is frequently associated with pelvic organ prolapse (POP) and it is reasonable to postulate, that treatment of POP will also have an impact on DPS. We aimed to evaluate the subjective satisfaction and improvement of DPS for patients who have undergone a sacral colpoperineopexy associated with retrorectal mesh for concomitant POP. Methods: This retrospective cohort study, conducted between February 2010 and May 2016 included all women who had undergone surgery to treat POP and DPS. Improvement of POP was assessed clinically and subjective satisfaction was assessed with a survey. Results: Among the 37 operated patients, 31 responded to the questionnaire and 77.4% were satisfied with this surgical procedure. 94.6% were objectively cured for POP. There was a 60% improvement rate for constipation, 63.5 and 68% were cured or improved for ODS and the need for digital maneuvers respectively. Conclusion: Sacral colpoperineopexy associated with retrorectal dorsal mesh appears to objectively and subjectively improve POP associated with DPS.

Transvaginal treatment of anterior and apical genital prolapses using an Ultra lightweight mesh: Restorelle® Direct Fix™. A retrospective study on feasibility and morbidity.

BACKGROUND: Vaginal mesh safety information is limited, especially concerning single incision techniques using ultra lightweight meshes for the treatment of anterior pelvic organ prolapse (POP). OBJECTIVE: To determine the intraoperative and postoperative complication rates after anterior POP repair involving an ultralight mesh (19g/m2): Restorelle® Direct Fix™. METHODS: A case series of 218 consecutive patients, operated on between January 2013 and December 2016 in ten tertiary and secondary care centres, was retrospectively analyzed. Eligible patients had POP vaginal repair (recurrent or not) planned with anterior Restorelle® Direct Fix™ mesh (with or without posterior mesh). Surgical complications were graded using the Clavien-Dindo classification. RESULTS: Intraoperative complications were bladder wound (0.5%), rectal wound (0.5%), ureteral injuries (0.9%). 98.2% of the patient did not have per operative complications. We observed one fail of procedure. Early complications mainly included urinary retention (8.7%) urinary tract infections (5.5%) and haematoma (2.7%). One haematoma required surgical treatment and another, embolization. 80.7% of the patient did not have complications during hospitalization and 80.3% did not have complication at the follow up visit. None of the analyzed factors (age, body mass index, surgical history, grade of prolapse or concomitant procedure) was significantly associated with the risk of perioperative complications. A total of 2.8% patients had grade III complications according Clavien Dindo. None had grade IV or V. CONCLUSIONS: This multicentre case-series on the early experience of the use of anterior Restorelle® Direct Fix™ mesh showed a satisfactory technical feasibility and a low rate of grade III complications according Clavien Dindo. Long term studies are necessary to assess anterior Restorelle® Direct Fix™ mesh performances and to appraise patient satisfaction feedback.

Safety of Vaginal Mesh Surgery Versus Laparoscopic Mesh Sacropexy for Cystocele Repair: Results of the Prosthetic Pelvic Floor Repair Randomized Controlled Trial.

BACKGROUND: Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. OBJECTIVE: To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45-75 yr, without previous prolapse surgery. INTERVENTION: Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rate of surgical complications ≥grade II according to the modified Clavien-Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results. RESULTS AND LIMITATIONS: A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI -1.5 to 18]; p=0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p=0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI -0.4 to 13.3]; p=0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS). CONCLUSIONS: LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS. PATIENT SUMMARY: Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.

Surgical management of pelvic organ prolapse in women: how to choose the best approach.

Although benign, pelvic organ prolapse is a real public health problem, affecting mostly women above sixty-five. Eighty-year-old women have an 11.1% lifetime risk of undergoing surgery for prolapse or stress urinary incontinence and 29% will need a second procedure. Surgical approach may be abdominal (sacrocolpopexy by laparotomy, laparoscopy or robot-assisted) or vaginal (autologous, or prosthetic reinforcement). In addition to anatomical correction, surgical objectives include: improvement of the patient's quality of life, prolapse symptoms relief, normal urinary, digestive and sexual functions and especially, avoiding iatrogenic sequelae. Thus, the choice of the surgical approach does not only depend upon the site and the severity of the prolapse. Urogynecological surgeons should take into consideration the patient's expectations and life style, her age--a determinant factor in deciding upon the best approach -, and her relapse risk factors. They should master both approaches, and the management of surgical complications. Therefore, an apprenticeship in a reference pelviperineology center is a must. In addition, surgeons should be aware of and consider contraindications to each procedure, for instance contraindications to transvaginal prosthesis reinforcement like risk factors of bad healing or infection. Urogynecology specialists have to take into consideration known anatomical and functional results of each technique as cited in the medical literature and act in accordance with international recommendations. The surgery's main objective is to ameliorate the patient's discomfort and her quality of life without causing iatrogenic dysfunctional symptoms (urinary, digestive, sexual). The pelvic organ prolapse being a benign pathology, the patient's satisfaction is the main marker of the procedure success. In short, regarding the surgical management of pelvic organ prolapse in women the answer to the question How to choose the best approach? is not binary. It depends on several factors, and regardless of the choice, it must

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical outcomes at 3 years following total transvaginal mesh (TVM) technique to treat vaginal prolapse. METHODS: Prospective, observational study in patients with prolapse ≥ stage II. Success was defined as POP-Q-stage 0-I and absence of surgical re-intervention for prolapse. Secondary outcome measures were: quality of life (QOL), prolapse-specific inventory (PSI), impact on sexual activity and complications. RESULTS: Ninety women underwent TVM repair, 72 a hysterectomy. Anatomical failure rate was 20.0% at 3 years. Three patients required re-intervention for prolapse. Improvements in QOL- and PSI-scores were observed at 1 and 3 years. Vaginal mesh extrusion occurred in 14.4% patients. After 3 years, 4.7% asymptomatic extrusions remained present. Of 61 sexually active women at baseline, a significant number of patients (41%) ceased sexual activity by 3 years; de novo dyspareunia was reported by 8.8%. One vesico-vaginal fistula resolved after surgery. CONCLUSION: Medium-term results demonstrate that the TVM technique provides a durable prolapse repair.

[Node clearance in ovarian cancer]. / Les curages lymphatiques dans les cancers de l'ovaire.

Iliac and lumboaortic lymphadenectomy is a frequent component of surgical treatment for ovarian carcinomas. These procedures carry specific risks and have poorly known immunological consequences. Two prospective randomized studies, one informs limited to the pelvis and the other in advanced disease, suggest that lymphadenectomy improves disease-free survival but not overall survival, although these findings are controversial. Modern imaging techniques (CT MRI, PET scan) and per-operative palpation are less sensitive than exhaustive histological examination of excised nodes. If lymphadenectomy is performed, it must be complete, including the external and primary iliac and lumboaortic chains up to the left renal vein, independently of the tumor location, as the lymphatic drainage pathway is difficult to predict in this setting In addition to their diagnostic value, node clearance also has therapeutic value. The risk of lymphatic invasion depends on the disease stage, grade, and histological type. Lymphadenectomy is not necessary for early-stage disease and is only warranted in advanced stages if the surgery is complete or the tumor residue is smaller than one centimeter.

[Descending perineum in women]. / Le périnée descendant de la femme.

Physiopathological and clinical interpretation of the descending perineum as described by A. Parks in 1970 remains difficult. This review is based on the literature between 1966 and 2004. The observed symptoms are more often due to associated lesions. The descending perineum on X-ray is not always symptomatic. Colpocystography shows the descent of the perineum and pelvic disorders from the anterior and middle parts of the perineum whereas defecography seems to provide a better diagnosis of dyschesia due to posterior damage (such as rectocele or endo-anal intussusception). The first step of treatment is reeducation and medical treatment because there is no consensus for surgical therapy. Soft sacrocolpopexy by the abdominal approach with three meshes, one under the bladder, one in front of and one behind the rectum can be proposed for complete descending perineum. Transanal rectal resection by staple could be useful when the descending perineum is only associated with a rectocele and/or an intra-anal intussusception.

Endorectal ultrasonography in predicting rectal wall infiltration in patients with deep pelvic endometriosis: a modern tool for an ancient disease.

PURPOSE: This study evaluated the validity of endorectal ultrasonography in predicting rectal infiltration in patients with deep pelvic endometriosis. METHODS: Patients were recruited consecutively in the Department of Surgical Gynecology of Diaconesses Hospital from April 1996 to July 2003. Inclusion criteria were the suspicion of deep pelvic endometriosis on the basis of outpatient history and/or clinical symptoms with a mass palpable on bimanual examination that might infiltrate the rectal wall. There were no exclusion criteria. Endorectal ultrasonography was performed by the same investigator with a 7.5-MHz to 10-MHz rigid probe, producing a 360 degrees view of the rectal wall and adjacent areas. We used surgical and histopathologic findings as the "gold standard" to evaluate the validity of endorectal ultrasonography. RESULTS: This study was based on 37 patients (mean age, 35.8 (range, 26-46) years) who underwent surgery. The time between endorectal ultrasonography and surgery ranged from 4 to 529 (mean, 88.7) days. Eight patients had endometriosis nodules penetrating the rectal wall. Endorectal ultrasonography showed sensitivity, specificity, a positive predictive value, and a negative predictive value of 87.5, 97, 87.5, and 97 percent, respectively, in the diagnosis of infiltration of the rectal wall by endometriosis. CONCLUSIONS: Endorectal ultrasonography is a reliable technique for visualizing rectal infiltration in patients with deep pelvic endometriosis. It should be more widely used by gynecologists because knowing about rectal infiltration before surgery is fundamental to defining the best possible surgical approach.

[Descending perineum in women]. / Le périnée descendant de la femme.

The descending perineum syndrome, described in 1970 by Alan Parks, remains difficult to interpret clinically and pathophysiologically. A general review of descending perineum was conducted, based on review of the literature published between 1966 and 2004, and retrospective analysis of 1,023 colpocystograms. The symptoms observed are usually secondary to associated lesions. Radiological signs of descending perineum are not always associated with clinical symptoms. Colpocystogram shows perineal descent and associated disorders of anterior and middle pelvic tone, while defecography provides a better explanation for dyschezia which is generally due to an associated posterior disorder (rectocele with rectal intussusception). The management of descending perineum is based on medical treatment and retraining. No consensus has been reached concerning surgical management. Surgery is generally used to treat associated lesions. In the case of complete collapse of perineum, an abdominal approach with infravesical, prerectal and retrorectal tension-free tape to the sacrum could be useful, while transanal staple repair of the rectum could be proposed when descending perineum is associated with only rectal intussusception or rectocele.

Laparoscopic sacrocolpopexy with two separate meshes along the anterior and posterior vaginal walls for multicompartment pelvic organ prolapse.

STUDY OBJECTIVE: To assess the feasibility and results of laparoscopic sacrocolpopexy (LSC) with two separate meshes along the anterior and posterior vaginal walls in correcting multicompartment pelvic organ prolapse (POP). DESIGN: Prospective study (Canadian Task Force classification I). SETTING: Tertiary care university-affiliated teaching hospital. PATIENTS: Forty-six consecutive women with radiologic diagnosis of multicompartment POP with or without genuine stress urinary incontinence and no history of surgery for either disorder. INTERVENTION: LSC with or without laparoscopic Burch colposuspension or tension-free vaginal tape procedure. MEASUREMENTS AND MAIN RESULTS: LSC was performed in 89% of patients. Mean operating and hospitalization times were 171 +/- 37 minutes and 4.0 +/- 2.1 days, respectively. Intraoperative complications were 7% of bladder injuries successfully treated by laparoscopic suture. The success rate for POP was 83%. The main recurrence was rectocele (12%), which occurred only among women undergoing LSC plus laparoscopic Burch colposuspension (P = 0.036). The LSC was effective in treating symptoms in 95% of women. Because of excessive mesh tension, one patient (2%) developed obstructed defecation, and two (5%) had de novo urinary incontinence. In no patient did occlusion or mesh infection and/or erosion in adjacent organs occur. CONCLUSION: LSC appears to be feasible and effective in treatment of multicompartment POP. Performing concomitant Burch colposuspension significantly enhances the risk of rectocele recurrence or development.