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

Ferry, P.; Bertherat, Pauline; Gauthier, Anne‐Sophie; Villet, R.; Piano, Francesco Del; Hamid, D.; Fernandez, H.; Broux, Pierre-Louis; Salet-Lizee, D.; Vincens, E.; Ntshaykolo, Pierre; Debodinance, P.; Pocholle, P.; Thirouard, Y; Tayrac, Renaud de

doi:10.1016/j.jogoh.2018.06.001

Cited by 10 publications

(7 citation statements)

References 30 publications

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“…A low rate of serious complications was reported in accordance with previous studies that evaluated the new generation of mesh kit . Moreover, the rate of mesh exposure was lower at 3% than previous studies.…”

Section: Discussionsupporting

confidence: 88%

Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial

Allegre

Debodinance²,

Dematteï

et al. 2019

Neurourology and Urodynamics

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Aims To evaluate the safety and efficacy of the Uphold LITE mesh in the treatment of pelvic organ prolapse at 12‐month follow‐up. Methods Women undergoing a mesh surgery due to an anterior prolapse plus a symptomatic anterior prolapse (classed as pelvic organ prolapse quantification stage ≥2) were included in this prospective, multicentre, observational study. The primary endpoint was a composite outcome including a good anatomical correction, no prolapse symptoms, and no reintervention for an anterior or apical recurrent prolapse within 12 months of surgery. Secondary outcomes included safety, improvements in quality of life (QoL), and risk factor for recurrence. This study was registered with ClinicalTrials.gov, number NCT01559168. Results A total of 121 patients were included. Symptomatic and anatomic cure rates were 94% (95 of 101) and 76.8% (76 of 99), respectively. The composite success rate was 72.4% (71 of 98). The rate of reoperation for apical or anterior recurrent prolapse was 3.9% (4 of 103). Anatomical anterior or apical recurrence occurred in 18.2% (18 of 97) and 7.2% (7 of 97) of patients, respectively. The composite success rate was significantly higher in centres where more than 30 patients had been treated (80% vs 50%; P = .045). The rate of serious complication was 5.4% (6 of 111). Improvements were recorded in QoL including sexual function. Conclusions The Uphold LITE mesh procedure provides satisfactory outcomes in the treatment of anterior and apical prolapse, particularly in high‐volume centres. The rates of adverse effects and reintervention for recurrent prolapse were acceptable.

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Section: Discussionsupporting

confidence: 88%

Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial

Allegre

Debodinance²,

Dematteï

et al. 2019

Neurourology and Urodynamics

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“…In the short and medium term, our results are similar to the articles published in relation to the success rate of studies with the same device and implantation route (92% in our series vs. 80.3%) [22] and different prosthetic devices but with the same implantation route (91.3%) [35], although its comparison is difficult due to the existence of different follow-up times. In our series, the minimum follow-up time was 6 months, while in studies such as the one published by Ferry et al [22] they only had 3 months of follow-up. We could say that our success rate is slightly higher, despite a longer follow-up.…”

Section: Discussionsupporting

confidence: 89%

“…If we compare other techniques with a recent boom, such as laparoscopic or robotic sacrocolpopexy [27,28], there are also no great differences with respect to the success rate, 92% in our series versus 80-100% in those mentioned. Our anatomical correction rate at 6 months of follow-up was 91%, similar to that found in other studies with this same device, 87.9% [22] or other light weight devices with the same implantation route, which oscillates between 79 and 96.5% [35][36][37], although their comparison is equally difficult due to different follow-up times. This same mesh surgery with the same anatomical correction rate criterion was 98.7% at 36 months for De Tayrac et al [21] and 93.7% for Denance´ et al [38].…”

Section: Discussionsupporting

confidence: 88%

“…In a study published with the Restorelle® device, an extrusion rate of 2.8% was observed, lower than that obtained at our center. Again, this difference can be justified because the postsurgical follow-up at our center was more than double that of the referenced study [22]. Furthermore, in general, we can affirm that it is difficult to compare our data with the literature, as there is great diversity of previously available prosthetic products.…”

Section: Discussionmentioning

confidence: 73%

“…80.3% did not present complications during the 3 months of study follow-up. Despite these promising data, the follow-up time of this study is short to ensure the absence of complications within a longer follow-up period [22]. Despite the current negative sentiment around transvaginal mesh, these new lightweight mesh products require further reassessment.…”

Section: Surgical Treatment Of Pelvic Organ Prolapsementioning

confidence: 94%

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Surgical Treatment of Pelvic Organ Prolapse

Fernández-Ávila¹,

García-Baquero²,

Claro³

et al. 2022

Pelvic Floor Dysfunction - Symptoms, Causes, and Treatment

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The human being is the only mammal capable of walking and simultaneously maintaining an upright position. This fact, implies somewhat unfavorable repercussions for the pelvic region that must support the weight of the abdominal organs. A prime example of the aforementioned adverse effects of the standing position are pelvic organ prolapses (POP). POP surgery is an increasingly important therapeutic aspect in clinical practice due to the aging of our population, and is increasingly prevalent as a therapeutic option. Surgical techniques can be performed using an abdominal or vaginal approach, depending on the medical history, physical examination, and experience of the surgeon. Laparoscopic sacrocolpopexy is an adequate therapeutic option with a high success rate in 80–100% of cases. However, this technique is not always appropriate, especially for patients who are at high risk for anesthesia, a multi-operated abdomen, or in recurrent prolapse. In these cases, a vaginal approach offers an interesting surgical alternative. In this review, we added our experience with transvaginal single-incision mesh under locoregional anesthesia for correction of female POP. We retrospectively analyzed 78 patients showing a success rate of 92% after more than 12 months of follow up. Transvaginal mesh was developed to maintain the advantage of a vaginal procedure, while reducing the risk of recurrent prolapse compared to native tissue repair and simplifying the surgery compared to sacrocolpopexy.

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