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).

[PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. / Étude randomisée comparant la promontofixation cœlioscopique à la chirurgie prothétique par voie vaginale pour le traitement des cystocèles : PROSPERE (PROSthetic PElvic organ prolapse REpair).

BACKGROUND: Cystocele is a frequent and invalidating type of genital prolapse in woman. Sacropexy using synthetic mesh is considered the surgical gold standard, and the laparoscopic approach has supplanted the open abdominal route because it offers the same anatomical results with a lower morbidity. The use of mesh through the vaginal route may have many advantages: easiness to perform, shorter operative time and recovery, but may increase morbidity. In France, both laparoscopic sacropexy and vaginal mesh are commonly used to treat cystoceles. The French Haute Autorité de santé (HAS) has highlighted the lack of evaluation of safety assessment for vaginal meshes. METHOD/DESIGN: The main objective of the study is to compare the morbidity of laparoscopic sacropexy with vaginal mesh for cystocele repair. The primary endpoint will be the rate of surgical complications greater or equal to grade 2 of the Clavien-Dindo classification at 1-year follow-up. The secondary aims are to compare the functional results in the medium term (sexuality, urinary and bowel symptoms, pain), the impact on quality of life as well as anatomical results. PROSPERE is a randomized controlled trial conducted in 12 participating French hospitals. 262 patients, aged 45 to 75years old, with cystocele greater or equal to stage 2 of the POP-Q classification (isolated or not) will be included. Exclusion criterias are a previous surgical POP repair, and inability or contra-indication to one or the other technique. We have designed this study to answer the question of the choice between laparoscopic sacropexy and vaginal mesh for the treatment of cystocele. The PROSPERE trial aims to help better determine the indications for one or the other of these techniques, which are currently based on subjective choices or school attitudes. This is the reason why competent authorities have asked for such studies.

Prolapse repair using the Elevate™ kit: prospective study on 70 patients.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to examine the anatomical and functional results of prolapse repair by a vaginal approach using the Elevate kit. METHODS: This was a prospective study of 70 patients presenting with symptomatic urogenital prolapse. Twenty Elevate Anterior, 16 Posterior, and 34 Anterior and Posterior repair systems were placed. Perioperative and postoperative complications were assessed. The patients were interviewed at 2 months and 1 year post-surgery. RESULTS: Recurrences were recorded in 21 patients (31.3%) at the 1-year follow-up. However, at the 1-year follow-up, there were 14 cases (20.9%) of direct recurrence (two anterior, two posterior, and ten combined anterior and posterior) compared with seven cases (10.4%) of indirect recurrence. Of the 21 failures (stage ≥ 2), 13 were stage 2 with the leading edge above the hymen. None of the patients underwent revision surgery. The exposure rate was 4.5%. The anterior and posterior shrinkage rates were 68.7% and 31.9%, respectively. There were four cases of de novo dyspareunia. Patients reported a significant decrease in the impact of pelvic floor distress on the PFIQ-7 questionnaire, but an improvement on the PFDI-20. There was no improvement in sexual function (PISQ-12). CONCLUSIONS: The Elevate™ kit is associated with satisfactory functional results. However, the anatomical results require ongoing evaluation.

[Miniarc : prospective study and follow up at one year about 72 patients]. / MiniArc : étude prospective et suivi à un an d'une série de 72 patientes.

OBJECTIVE: To evaluate the results at 1 year of a mini invasive sub urethral sling, not requiring no more a single incision. PATIENTS AND METHODS: Prospective study of 72 patients with isolated stress urinary incontinence. The procedures were performed on an outpatient under local anesthesia. Pain was assessed using the visual analogue scale. All patients were checked at 2 months and 1 year of intervention. RESULTS: Stress urinary incontinence for 58 patients, 14 for mixed incontinence and sphincter deficiency for five. As per procedure, the average pain was 3.7/10, at the end of the intervention, 0.5/10. Peroperative complications were: one episode involving bleeding over 100ml, one vasovagal episode, and one procedure failure. At 2 months follow-up, the authors recorded: de novo urge incontinence (n=2), de novo dysuria (n=1), sling exposure (n=1), urinary infection (n=1) and noticeable side ties (n=4). Control at 1 year, another patient filed an eviction of the anchor of the tape with Stall thereof. Two patients reported having moderate pain. The objective results at 1 year of 68 patients were 69.1% cured, 20.6% improved and 10.3% failed. Three patients were re-operated and two of them are cured. CONCLUSION: The results of this simplified tape are worse than those of classic sub-urethral tape; however, no comparative study has been completed and the specific indications of these techniques are not specified.

[MiniArc: preliminary prospective study on 72 cases]. / MiniArc : résultats à court terme d'une série prospective de 72 cas.

OBJECTIVES: To present a new mini-invasive tape requiring only a single incision, to assess the complications and short-term results. MATERIALS AND METHODS: Prospective study of 72 patients with stress urinary incontinence. Were selected for the study patients with stress urinary incontinence with or without intrinsic sphincter deficiency and mixed urinary incontinence with a predominance of leaks to the effort. Patients were evaluated at 2 months of the intervention. RESULTS: Isolated stress urinary incontinence for 58 patients, mixed incontinence for 14 and intrinsic sphincter deficiency for five. The complications per procedure revealed one bleeding over 100ml, one malaise vagal and a failure of the procedure. At 2 months, the authors found: two urgenturies de novo, one de novo micturition disorder, one erosion, one urinary tract infection and four lateral vaginal bands. The early objective results are overall 75.7% of dry patients (79.6% for pure SUI, 66.6% for IUE with ISD and 61.5% for mixed incontinence). The overall failure rate was 2.9%. CONCLUSION: The results of this simplified tape are worse than those of TVT and transobturator tapes.

[Validity of local anesthesia for female stress urinary incontinence surgery with sub-urethral sling]. / Bien-fondé de l'anesthésie locale pour la pose de bandelettes sous-urétrales dans la cure d'incontinence urinaire chez la femme.

OBJECTIVE: To evaluate the feasibility and the comfort of the local anesthesia more or less associated with a light sedation for the sub-urethral vaginal tape in the urinary incontinence surgery. MATERIAL AND METHODS: In a series without selection, 138 patients, benefiting from the isolated sub-urethral vaginal tape surgery (51: Monarc; 18: TVT-O((R)) and 69: TVTSecur, are submitted, after premedication (alpazolam, hydroxyzine), to a pure local anesthesia (ropivacaine-clonidine and adrenalin) for the TVTSecur and associated with a light sedation (midazolam-sufentan) for the TVT-O and Monarc. The anxiety, the peroperative pain and the satisfaction of patients have been evaluated by an analogical visual scale (EVA). RESULTS: No significant difference is put in obviousness for the preoperative anxiety in three groups, similarly for the peroperative pain classified in three group, EVA: 1-30, 40-60 and 70-100mm with, respectively, for Monarc 54.9, 35.3 and 7.8%, for TVT-O 77.8, 22.2 and 0% and for TVTSecur 47.8, 43.5 and 8.7%. In the postoperative period, analgesics have been prescribed for 92.2 and 94.4% of Monarc and TVT-O and for 7.2% of TVTSecur. More than 92% of patients recommend this type of anesthesia. DISCUSSION: Contrarily to the majority of authors that use a deep sedation, the weak dose that we have used allows a perfected vigilance. The interest of ropivacaine associated with clonidine was both to have a vasoconstrictor effect and a prolongation of the analgesic effect with a lesser toxic effect than lidocaine and bupivacaine. CONCLUSION: We militate for a return to a minimal invasive anesthesia as that described initially by promoters of the tension-free vaginal tape (TVT), that allows the sub-urethral vaginal tape surgery, under local anesthesia with light sedation, in ambulatory of comfortable manner for patients.

[Complications of urinary incontinence surgery: 800 procedures]. / Complications des cures d'incontinence urinaire: à propos de 800 interventions.

OBJECTIVE: To present the complications of urinary incontinence surgery through our experience over 13 years with 800 procedures in continuous practice. These complications were compared to those of the literature for the same type of procedure. STUDY DESIGN: From January 1988 to September 2001, 800 procedures were performed in the same hospital in the gynecology unit. The procedures were: Bologna (91 cases), laparotomic Burch (83 cases), laparoscopic Burch (62 cases), Pereyra (112 cases), Stamey (8 cases), Ingelman-Sundberg (27 cases), Mouchel (40 cases), autograft sling (22 cases), mesh sling: small size (62 cases), large size (12 cases) et TVT (tension free vaginal tape) (281 cases). These procedures were performed alone in 475 cases (125 cases with hysterectomy for other reason), and in 325 cases associated with prolapse surgery. The complications were noted during the hospitalization and at the control at 3 months and 1 year. We only noted the complications attributable to the different procedures. RESULTS: Bladder injuries are found in 3.5% (0 to 6%), hemorrhage in 1% (0 to 3.8%), urinary infection in 4.5% (0 to 11.3%), fever at 48 hours in 1.5% (0 to 9.7%), momentary urine retention in 17% (1.6 to 64.5%), de novo dysuria in 10.9% (0 to 35.5%), de novo urge in 6.9% (0 to 11%). For the other complications, which were less frequent or more procedure-specific, we noted: subcutaneous emphysema in 1.6% of the laparoscopic Burch procedures, cutting thread in 4.8% of the laparoscopic Burch procedures and 2.7% in Pereyra, rejection of prosthetic mesh in 9% of the large slings, 14% with the small sling and 28.2% with the Mouchel procedure, a wound abscess in 3.8% of the Bologna procedures, 1.2% of laparotomic Burch procedures. The percentage of women who had at least one complication was a minimum of 18% for TVT and a maximum of 62.9% for small synthetic sling. In summary, 32% of the patients presented at least one complication. Overall, we noted urinary complications in 41% of the patients, which accounted for 81% of the complications. DISCUSSION: We reviewed more than 100 references concerning complications of the procedures performed in these patients. "Blind" procedures gave more bladder injuries, slings more dysuria and urine retention and procedures using mesh gave more pool healing or rejection especially with the old materials. A particular place must be made for the TVT, recent procedure, which is widely studied. We reviewed 35 references explaining complications of TVT or proposing preventions measures. CONCLUSION: There are many complications of urinary incontinence surgery, but the majority is quickly resolved without consequence. The only after-effects are dysuria which are the most often slow micturition, and urge which are a real problem, sometimes leading to sling removal.

[Development of better tolerated prosthetic materials: applications in gynecological surgery]. / Evolution des matériaux prothétiques vers une meilleure tolérance: application en chirurgie gynécologique.

UNLABELLED: Meshes have come to be widely used for surgical repair of the dysfunctional pelvic floor. The problem to date has been mesh intolerance. History. The first meshes were made with silver filigrees or stainless steel. Non-metallic and non-absorbable synthetic prostheses include nylon, silastic, polytetrafluoroethylene as well as expansive polyester and polypropylene forms. Most of the absorbable prostheses are made of polyglycolic acid and polyglactine 910. Classification. Four groups of biomaterials can be described according to pore size. Mechanical and biological properties. The mechanical properties of meshes have been tested industrially for resistance, pliability, elasticity and ductile qualities. These properties depend on type of tissue structure (woven or knitted) and the type of fiber used (mono and multi-filaments). The goal is to obtain a "silent" material, i.e. a material which does not trigger a host tissue reaction. Introducing the foreign body induces a "scarring" response. This fibroblastic reaction replaces the inflammatory reaction, leading to progressive colonization of the prosthesis. The major risk is infection caused by a disturbance of the inflammatory phase and bacterial development. Bacteria can be trapped in fibrotic tissue, with the risk of delayed infection. Immunological reactions may have an additive effect. These problems are not encountered with absorbable meshes. An ideal implant material must: not undergo physical modification by tissue fluids, be chemically inert, not trigger inflammatory or foreign body cell response in body tissues, be noncarcinogenic and nonallergenic, be capable of resisting mechanical stress and sterilization, and be able to be manufactured in the necessary shape. Polyester, polypropylene and expansive polytetrafluoroethylene fulfill these criteria. The ideal mesh. Eleven criteria are proposed. Complications for hernia repair. Infection and seroma are the most frequent complications with micro-porous meshes. Macro-porous meshes can cause erosive phenomena and adhesions. Retraction of synthetic tissues is observed in 20 to 30% of cases. Meshes in gynecology. In gynecology surgery, meshes made their first appearance in trans-abdominal sacrocolpopexy and slings. A detailed review of complications found in 32 articles studying slings and 22 studying sacrocolpopexy with approximately 10 types of meshes shows that intolerance of slings has oscillated between 1% with Prolene and 31% with Gore-Tex; for abdominal sacrocolpopexy the rate was between 1.7% with Prolene and 20% with Teflon. Rejection phenomena appear during the first year and are proportional to the surface area of the synthetic tissue and the proximity of the vaginal scar. New materials have been proposed over the last ten years for prolapse surgery, notably for cystocele, which accounts for 70% of all repair procedures. Nearly fifteen studies have reported a level of intolerance reaching 6%, the large majority of the meshes used being Prolene meshes. Our personal experience with 87 repair procedures has led us to the conclusion that Prolene is the most adapted mesh, allowing free tension between the bladder and the anterior vaginal wall. CONCLUSION: Continuous evaluation is needed to study these replacement materials which should in theory, improve the rate of recurrence, which is at present 20% with classic procedures not using a mesh.

[Tolerance of synthetic tissues and vaginal surgery. Report of 287 cases]. / Tolérance des tissus synthétiques et chirurgie vaginale. A propos de 287 cas.

OBJECTIVE: In this presentation, we attract attention to the disadvantage of using synthetic material in functional surgery of prolapse and urinary incontinence. PATIENTS AND METHODS: Two hundred eighty seven vaginal operations using synthetic material (Gore Tex, Dacron and Lyodura) were followed. The operations were: Mouchel procedure (127 cases), small slings (118 cases), large slings (11 cases), Stamey procedure (8 cases) and patch for paravaginal repair (23 cases). These operations were performed from 01/01/89 to 31/12/95. RESULTS: Mean follow-up at study end was 49 months. The intolerance phenomenon, leading to rejection, occurred between 1 and 72 months. The Mouchel procedure gave a rejection rate of 28.3% versus 9.3% for the slings (p < 0.001). Dacron was better tolerated (rejection rate at 19.3%) than Gore tex (rejection rate at 30.2%), p < 0.05. CONCLUSION: The substratum of the intolerance process would have two explanations (infection and foreign body reaction) for the early and late rejections. We suggest that the synthetic tissue tolerance is proportional to the exposed surface and to the distance which separates it from the vaginal scar. The ideal synthetic mesh material for pelvic surgery has yet to be developed.

[Preoperative localization of asymptomatic breast lesions by the technique of stereotaxic tattooing and use of a wire. Apropos of 670 cases]. / Repérage pré-opératoire des lésions mammaires infracliniques par la technique du tatouage stéréotaxique et du "harpon". A propos de 670 observations.

OBJECTIVE: To compare the quality of pre-operative analysis of sub-clinical lesions of the breast using a wire and stereotaxic tattooing. METHODS: Between 1983 en 1990, 670 cases were analysed. At first needle or wire localisation techniques were used and then from 1988 onwards stereotaxic tattooing, first with the wire technique combined with it and later by itself from 1989 onwards. PLACE STUDY CARRIED OUT: Oscar-lambret Centre in the Department of Surgery and Radiodiagnosis I, BP 307, Lille Cedex. RESULTS: 190 carcinomas were diagnosed (30.7%) of which 20 were micro-invasive and 46 carcinoma in situ. The efficiency of the analysis was evaluated according to the number of explorations that were necessary to remove healthy tissue around the lesion. The wire technique results were significantly different (15.43% = 339 cases), tattooing with wire (9.13% = 144 cases), and tattooing by itself (6.30% = 135 cases). CONCLUSION: It seems that pre-operative assessment using stereotaxic tattooing is the most reliable of methods because it allows limited excision of the lesion and a more aesthetic approach.

[Preoperative marking of non-palpable breast lesions by the stereotaxic tattooing and "harpoon" technique. 670 cases]. / Repérage pré-opératoire des lésions mammaires infracliniques par la technique du tatouage stéréotaxique et du "harpon". A propos de 670 observations.

OBJECTIVE: To compare the quality of pre-operative analysis of sub-clinical lesions of the breast using a wire and stereotaxic tattooing. METHODS: Between 1983 en 1990, 670 cases were analysed. At first needle or wire localisation techniques were used and then from 1988 onwards stereotaxic tattooing, first with the wire technique combined with it and later by itself from 1989 onwards. Place study carried out: Oscar-lambret Centre in the Department of Surgery and Radiodiagnosis 1, BP 307, Lille Cedex. RESULTS: 190 carcinomas were diagnosed (30.7%) of which 20 were micro-invasive and 46 carcinoma in situ. The efficiency of the analysis was evaluated according to the number of explorations that were necessary to remove healthy tissue around the lesion. The wire technique results were significantly different (15.43% = 339 cases), tattooing with wire (9.13% = 144 cases), and tattooing by itself (6.30% = 135 cases). CONCLUSION: It seems that pre-operative assessment using stereotaxic tattooing is the most reliable of methods because it allows limited excision of the lesion and a more aesthetic approach.