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Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial
- Source :
- Neurourology and Urodynamics, Neurourology and Urodynamics, Wiley, 2019, 38 (8), pp.2242-2249. ⟨10.1002/nau.24125⟩
- Publication Year :
- 2019
-
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.
- 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
Subjects
Details
- ISSN :
- 15206777, 01559168, and 07332467
- Volume :
- 38
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Neurourology and urodynamics
- Accession number :
- edsair.doi.dedup.....cac2d6ad649a2562931b79bb124bf6ba