D'alessandro Gloria, Leone Maurizio, Antolini Jacopo, Ferrero Simone, Sala Paolo, Melloni Guglielmo, Fasolis Giuseppe, Gustavino Claudio
Academic Unit of Obstetrics and Gynecology, San Martino IRCCS and Polyclinic Hospital, Genoa, Italy -
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Genoa, Italy -
Minerva Ginecol. 2020 Feb;72(1):12-18. doi: 10.23736/S0026-4784.20.04496-2.
The purpose of the study is to report three years follow-up of single incision slings for the treatment of stress urinary incontinence (SUI). The main outcomes are to evaluate the efficacy of the device and to assess safety, adverse events, quality of life, demographic features of treated women and prognostic factors for SUI.
We performed a retrospective, double-center, single-arm study. Data were collected by medical records and a telephone interview 3 years after the implant of the mini-sling. Complication rate, subjective efficacy and degree of satisfaction were investigated.
Fifty-four patients were treated between March 2015 and March 2017, of which 47 answered the survey. Forty-one of 47 procedures (87.2%) were considered effective. Among more relevant complications, there was one case of extrusion of mesh and three cases of new onset of urinary disfunction, of which two cases of urgency urinary incontinence (UUI) and one case of de-novo SUI. Most complications were solved within few days after the procedure. Concerning the subjective impression of improvement, investigated by using the Patient Global Impression of Improvement (PGI-I) questionnaires, 41 patients reported subjective satisfaction, three reported no change in quality of life and three patients had worsening of symptoms.
The procedure was safe and effective for the treatment of SUI but more data are needed to confirm our preliminary results.
本研究旨在报告单切口吊带治疗压力性尿失禁(SUI)的三年随访情况。主要结果是评估该装置的疗效,并评估安全性、不良事件、生活质量、接受治疗女性的人口统计学特征以及SUI的预后因素。
我们进行了一项回顾性、双中心、单臂研究。通过病历和在植入微型吊带3年后进行电话访谈收集数据。调查并发症发生率、主观疗效和满意度。
2015年3月至2017年3月期间共治疗了54例患者,其中47例回复了调查。47例手术中有41例(87.2%)被认为有效。在较为严重的并发症中,有1例网片挤出和3例新发排尿功能障碍,其中2例为急迫性尿失禁(UUI),1例为新发SUI。大多数并发症在术后几天内得到解决。关于使用患者总体改善印象(PGI-I)问卷调查的主观改善印象,41例患者报告主观满意,3例报告生活质量无变化,3例患者症状恶化。
该手术治疗SUI安全有效,但需要更多数据来证实我们的初步结果。