Our goal was to report the preliminary results of a transvaginal mesh repair of genital prolapse using the Prolift™ system. This retrospective multicentric study includes 110 patients. All patients ...had a stage 3 (at the hymen) or stage 4 (beyond the hymen) prolapse. Total mesh was used in 59 patients (53.6%), an isolated anterior mesh in 22 patients (20%) and an isolated posterior mesh in 29 patients (26.4%). We report one bladder injury sutured at surgery and two haematomas requiring secondary surgical management. At 3 months, 106 patients were available for follow-up. Mesh exposure occurred in five patients (4.7%), two of them requiring a surgical management. Granuloma without exposure occurred in three patients (2.8%). Failure rate (recurrent prolapse even asymptomatic or low grade symptomatic prolapse) was 4.7%. According to the perioperative and immediate post-operative results, Prolift™ repair seems to be a safe technique to correct pelvic organ prolapse. Anatomical and functional results must be assessed with a long-term follow-up to confirm the effectiveness and safety of the procedure.
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.
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At 4 years, Laparoscopic Sacropexy (LS) had a better benefit–harm balance with fewer re‐interventions due to complications than Trans‐Vaginal Mesh (TVM).
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At 4 years LS had a better benefit–harm balance with fewer re‐interventions due to complications than TVM.
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.
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Short‐term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.
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Short‐term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh.
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.
Introduction and hypothesis
To evaluate clinical effectiveness and complication rates at 5 years following the total Trans Vaginal Mesh (TVM) technique to treat pelvic organ prolapse.
Methods
...Prospective, observational, multi-centre study in patients with prolapse of stage II or higher.
Results
Of the 90 women enrolled in the study, 82 (91 %) were available for the 5-year follow-up period. At the 5-year endpoint, success, defined as no surgical prolapse reintervention and leading edge <−1 (International Continence Society ICS criteria) or above the level of the hymen, was 79 % and 87 % respectively. A composite criterion of success defined as: leading edge above the hymen (<0) and no bulge symptoms and no reintervention for prolapse was met by 90 %, 88 % and 84 % at the 1-, 3-, and 5-year endpoints respectively. Quality of life improvement was sustained over the 5 years. Over the 5-year follow-up period, a total of only 4 patients (5 %) required re-intervention for prolapse, while a total of 14 patients (16 %) experienced mesh exposure for which 8 resections needed to be performed. Seven exposures were still ongoing at the 5-year endpoint, all asymptomatic. Only 33 out of 61 (54 %) sexually active patients at baseline remained so at 5 years. De novo dyspareunia was reported by 10 %, but no new cases at the 5-year endpoint. One patient reported de novo unprovoked mild pelvic pain at 5 years, 5 reported pains during pelvic examination only.
Conclusions
Five-year results indicated that TVM provided a stable anatomical repair. Improvements in QOL and associated improvements in prolapse-specific symptoms were sustained. Minimal new morbidity emerged between the 1- and 5-year follow-up.
Objectives: To report the outcome and complications of a series of tension-free vaginal tape (TVT) operations and compare the results with the literature.
Materials and methods: A total of 256 cases ...with a minimum follow-up time of 3 months (May 1998–September 2001) were included (193 isolated TVT, 23 combined with vaginal hysterectomy and 63 combined with prolapse surgery). These cases included 21% of the patients presenting with mixed incontinence, 14% with sphincter deficiency and 9.8% with recurrent incontinence. The isolated TVT were carried out under local anesthesia an ambulatory procedure, the others were done under spinal anesthesia.
Results: Almost all the patients underwent a clinical check-up after 3 months and 1 year and also underwent urodynamic exploration; they were then questioned by means of a questionnaire after 2 and 3 years. The global cure rate was 90, 91, 83 and 87%, respectively. The authors observed 6.4% of recurrences between 3 months and 1 year and 7.2% between 2 and 3 years. For mixed incontinence at the three first check-ups, the cure rate was 75, 85 and 60%, respectively, with 7.4 and 20% of recurrences between these two intervals. The cure rates of the patients who had presented with sphincter deficiency were 76, 79 and 73%, respectively, with 16% recurrences during the first year. In the case of recurrent incontinence, a cure was obtained in 72 and 71% of cases, with 18% of recurrences. The complications consisted of 5.5% cases of perforated bladder, 0.4% hematomas of the Retropubic space, 3.1% urinary infections, 0.4% urethral injuries, 5.1% transient urine retention, 12.0% de novo urinary urgency and 20% de novo dysuria. It should be noted that half of the pre-operative urgencies had disappeared after the operation. No defective healing and rejection phenomenon was observed.
Discussion: The authors reviewed the results reported in 35 articles, and compare these with their own results. They also reviewed all the complications encountered, account for them and suggested how they can be avoided. There are discrepancies between the various studies, particularly with regard to the complications.
Conclusion: This minimally invasive operation should be further assessed so that it can demonstrate its effectiveness, and become the “Gold standard”. Randomized studies are awaited with this in view.
Evaluate functional and anatomical outcomes as well as complications, 1year after the implantation of the Ajust(®) sub-urethral adjustable single-incision sling.
Prospective study on 60 female ...patients suffering from stress urinary or mixed urinary incontinence with quality of life assessment. Ambulatory surgeries were performed under local anesthesia with or without sedation. Pain was evaluated using the VAS scale. Postoperative follow-up was performed at 2 and 12months.
Forty-eight patients suffered from stress incontinence only, with one of them suffering from sphincter deficiency, and the remaining 12 suffered from mixed urinary incontinence. Mean surgery time was 7.15minutes. All patients received a local anesthesia, and 33 were sedated. Per-operative pain level was equal to 31.8/100, and 17/100 upon discharge. A 100mL per-operative hemorrhage was described. At 2-month follow-up, four de novo urgency, four de novo dysuria, one urinary infection, 11 palpable lateral cords, 12 moderate postoperative pain were described. At 1-year follow-up, two mesh exposures formed, including one expelled anchor for one of them. At 1year, cure rate, improvement and failure rate were respectively 89.6%, 6.9% and 3.4%. Quality of life indexes were significantly improved. One patient required a new surgery at 2months, due to initial failure.
The efficacy of this mini-invasive sling, without specific complication, must be compared with the other classic sub-uretral slings.
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