Do Surgeons Anticipate Women’s Hopes and Fears Associated with Prolapse Repair? A Qualitative Analysis in the PROSPERE Trial

Women’s preoperative perceptions of pelvic-floor disorders may differ from those of their physicians. Our objective was to specify women’s hopes and fears before cystocele repair, and to compare them to those that surgeons anticipate. We performed a secondary qualitative analysis of data from the PROSPERE trial. Among the 265 women included, 98% reported at least one hope and 86% one fear before surgery. Sixteen surgeons also completed the free expectations-questionnaire as a typical patient would. Women’s hopes covered seven themes, and women’s fears eleven. Women’s hopes were concerning prolapse repair (60%), improvement of urinary function (39%), capacity for physical activities (28%), sexual function (27%), well-being (25%), and end of pain or heaviness (19%). Women’s fears were concerning prolapse relapse (38%), perioperative concerns (28%), urinary disorders (26%), pain (19%), sexual problems (10%), and physical impairment (6%). Surgeons anticipated typical hopes and fears which were very similar to those the majority of women reported. However, only 60% of the women reported prolapse repair as an expectation. Women’s expectations appear reasonable and consistent with the scientific literature on the improvement and the risk of relapse or complication related to cystocele repair. Our analysis encourages surgeons to consider individual woman’s expectations before pelvic-floor repair

Mechanical properties of synthetic implants used in the repair of prolapse and urinary incontinence in women: which is the ideal material?

International audienceThe authors review the literature concerning all types of synthetics implants used in prolapse repair or the treatment of stress urinary incontinence, and analyze the mechanical properties of and the tolerance to the various products used. Various synthetic implants are also studied, including their advantages and disadvantages, as well as outcome following implantation and tolerance by the host, with respect to the type of product and the type of intervention. A review of current implant products demonstrated that the perfect product does not exist at present. The most promising of theses products for applications in transvaginal surgery to restore pelvic function appears to be the synthetic prostheses made predominantly of polypropylene, which offer mechanical properties of durability and elasticity. Their properties of resistance are undisputed, but it remains to be shown whether they are well tolerated when inserted by the vaginal route. The technical modalities for their use are still under evaluation, which should enable a better identification of the respective indications for these products in prolapse repair and treatment of urinary incontinence by the vaginal route

Perioperative morbi-mortality after pelvic organ prolapse surgery in a large French national database from gynecologist surgeons

International audienceObjective To assess morbidity and mortality following pelvic organ prolapse surgery in France, irrespective of the surgical technique, using a broad national database. Materials and methods: This descriptive multicenter retrospective study was conducted using a database populated via an application run by a professional association. Results 286 gynecologists contributed data to the database. Of the 4322 surgeries analyzed, an abdominal approach was used in 975 of cases (22.5%), a vaginal approach in 3277 (75.9%), and a combined approach in 68 (1.6%). After one year, abdominal surgery was associated with higher rates of de novo urinary incontinence, constipation, and intestinal obstruction, whereas vaginal surgery was associated with higher rates of urinary retention, hematoma, de novo chronic pain, and vaginal mesh extrusion. There was no significant difference between the groups in the incidence of severe complications. After one year, vaginal mesh-augmented cystocele repair was associated with higher rates of de novo urinary incontinence, de novo chronic pain, and reoperation than native tissue repair. Mesh repair was also associated with higher rates of severe complications at one year. Conclusion After pelvic organ prolapse surgery, the perioperative morbidity and mortality associated with transabdominal and transvaginal approaches are similar. However, transvaginal mesh repair is associated with greater perioperative morbidity than transvaginal native tissue repair

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan–Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien–Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively

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

International audienceBACKGROUND: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

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

International audienceOBJECTIVE:Assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse.DESIGN:Prospective longitudinal cohort study by using a surgical registry.SETTING:13 public hospitals in France.POPULATION OR SAMPLE:1873 women undergoing surgery between February 2017 and August 2018.METHODS:Preliminary analysis of serious complications after a mean 7-month follow-up (0-18), 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:52 women (2.8%, 95% CI 2.1-3.6) experienced a serious complication during either the surgery, requiring discontinuation of the procedure, or the first months of follow-up, necessitating a subsequent reoperation; one case also required resuscitation; no women died. Of 811 midurethral slings (MUS), 11 were removed in part or totally (1.4%, 0.7-2.3), as were 2 of 391 transvaginal meshes (0.5%, 0.1-1.6), and 4 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 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 enlarged to assess the long-term risk associated with mesh use and identify its risk factors

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

International audienceObjective: 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)