Dubois Alexandre, Haudebert Camille, Richard Claire, Penafiel Juan, Freton Lucas, Voiry Caroline, Samson Emmanuelle, Manunta Andrea, Hascoet Juliette, Peyronnet Benoit
Department of Urology, University of Rennes, Rennes, France.
Department of Urology, University of Rennes, Rennes, France.
Eur Urol Focus. 2025 Jan 6. doi: 10.1016/j.euf.2024.12.002.
Artificial urinary sphincter (AUS) is commonly used in France in female patients with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). However, it has never been assessed using patient-reported outcomes. This study aimed to evaluate the functional outcomes of robotic AUS implantation using validated questionnaires.
The data from female patients who underwent robotic AUS implantation at a single academic center between 2014 and 2023 were collected prospectively. Preoperatively, all patients filled out a Urinary Symptoms Profile (USP) questionnaire, and the International Consultation Incontinence Questionnaire Short Form (ICIQ-SF). These were repeated at 3 mo postoperatively and annually along with a Patient Global Impression of Improvement (PGII) score. Quality of life was assessed using question 5 of the ICIQ-SF.
Over the study period, 101 robotic female AUS implantation cases were performed by three surgeons. The median patient age was 66 yr (interquartile range: 53-73), and 86.9% had a history of previous SUI surgery. In our cohort, 12 patients had neurogenic SUI (11.8%). In terms of complications, there were 16 intraoperative (15.8%) and 26 postoperative (25.7%) complications, all of Clavien grade 1 or 2 except seven of Clavien grade 3B (major complication rate: 6.8%). All patient-reported outcomes improved significantly at 3 mo. The USP SUI subscore decreased from 7.3 preoperatively to 0.8 at 3 mo (/9; p < 0.0001), the USP overactive bladder subscore decreased from 12.6 to 5.1 (/21; p < 0.0001), and the ICIQ-SF decreased from 16.5 to 3.1 (/21; p < 0.0001). Quality of life improved, with the ICIQ-QoL decreasing from 8.8 preoperatively to 0.9 at 3 mo (/10; p < 0.0001). The 3-mo PGII score was 1/7 (very much improved) in 79 patients (78.8%).
Robot-assisted AUS implantation in female patients has low morbidity and improves the patient-reported outcomes and quality of life of female patients with SUI due to ISD.
This study represents the largest cohort of robotic female artificial urinary sphincter (AUS) implantation in the literature and is the first to report the patient-reported outcomes (PROMs) after female AUS implantation using validated questionnaires. We found significant improvement in all PROMs at 3 mo, except for voiding dysfunction symptoms. This study brings new robust data to help the widespread use of female AUS across the world, even if further studies with longer follow-up are needed to confirm that these results are maintained over time. We then compared the continence status reported by the patients with PROMs, finding a significant association. This highlights that the existing literature on female AUS, which lacks such PROMs, remains of interest.
在法国,人工尿道括约肌(AUS)常用于因固有括约肌缺陷(ISD)导致压力性尿失禁(SUI)的女性患者。然而,从未使用患者报告结局对其进行评估。本研究旨在使用经过验证的问卷评估机器人辅助植入AUS的功能结局。
前瞻性收集2014年至2023年在单一学术中心接受机器人辅助AUS植入的女性患者的数据。术前,所有患者填写尿症状概况(USP)问卷和国际尿失禁咨询问卷简表(ICIQ-SF)。术后3个月和每年重复进行这些问卷,并给出患者整体改善印象(PGII)评分。使用ICIQ-SF的问题5评估生活质量。
在研究期间,三位外科医生共进行了101例机器人辅助女性AUS植入手术。患者年龄中位数为66岁(四分位间距:53 - 73岁),86.9%有既往SUI手术史。在我们的队列中,12例患者为神经源性SUI(11.8%)。在并发症方面,有16例术中并发症(15.8%)和26例术后并发症(25.7%),除7例Clavien 3B级(主要并发症发生率:6.8%)外,均为Clavien 1级或2级。所有患者报告结局在术后3个月均有显著改善。USP SUI子评分从术前的7.3降至术后3个月的0.8(满分9分;p < 0.0001),USP膀胱过度活动症子评分从12.6降至5.1(满分21分;p < 0.0001),ICIQ-SF从16.5降至3.1(满分21分;p < 0.0001)。生活质量得到改善,ICIQ-QoL从术前的8.8降至术后3个月的0.9(满分10分;p < 0.0001)。79例患者(78.8%)的术后3个月PGII评分为1/7(改善非常明显)。
机器人辅助女性患者植入AUS的发病率低,可改善因ISD导致SUI的女性患者的患者报告结局和生活质量。
本研究是文献中最大的机器人辅助女性人工尿道括约肌(AUS)植入队列,也是首个使用经过验证的问卷报告女性AUS植入术后患者报告结局(PROMs)的研究。我们发现除排尿功能障碍症状外,所有PROMs在术后3个月均有显著改善。本研究提供了新的有力数据,有助于AUS在全球范围内的广泛应用,尽管需要进一步进行更长时间随访的研究来确认这些结果是否能长期维持。然后,我们将患者报告的控尿状态与PROMs进行比较,发现存在显著关联。这突出表明,缺乏此类PROMs的现有女性AUS文献仍具有参考价值。