1. Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial
- Author
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Lucie Allegre, M. Cayrac, Christophe Courtieu, Renaud de Tayrac, Pascale Fabbro Peray, Christophe Demattei, Brigitte Fatton, Philippe Debodinance, Xavier Fritel, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Centre Hospitalier de Dunkerque, BESPIM, Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de gynécologie et obstétrique [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), and Clinique Beau Soleil [Montpellier]
- Subjects
Reoperation ,medicine.medical_specialty ,complications ,Urology ,030232 urology & nephrology ,Uphold LITE ,[SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology ,Pelvic Organ Prolapse ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Recurrence ,Risk Factors ,Clinical endpoint ,Medicine ,Humans ,Prospective Studies ,Risk factor ,Stage (cooking) ,Adverse effect ,Aged ,030219 obstetrics & reproductive medicine ,business.industry ,composite outcome ,Middle Aged ,Surgical Mesh ,transvaginal mesh ,3. Good health ,Surgery ,Treatment Outcome ,Apical prolapse ,Quality of Life ,Urologic Surgical Procedures ,Female ,Neurology (clinical) ,Patient Safety ,Sexual function ,business ,Complication ,Follow-Up Studies - Abstract
International audience; 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.
- Published
- 2019