Angulo Javier C, Arance Ignacio, Esquinas Cristina, Dorado Juan F, Marcelino João P, Martins Francisco E
Servicio de Urología, Departamento Clínico, Facultad de Ciencias Biomédicas, Hospital Universitario de Getafe, Universidad Europea de Madrid, Laureate Universities, Madrid, Spain.
Pertica S.L., Getafe, Madrid, Spain.
Adv Ther. 2017 May;34(5):1173-1183. doi: 10.1007/s12325-017-0528-5. Epub 2017 Apr 12.
The objective of this study was to report outcome measures with third-generation pre-attached scrotal port adjustable transobturator male system (ATOMS) for male stress urinary incontinence (SUI) after radical prostatectomy.
A prospective open study was conducted on consecutive patients. Evaluation included cough test, urethroscopy, filling and voiding cystometry, 24-h pad count and pad test, patient-reported outcomes (ICIQ-SF, IIQ-7, PGI, GRA, and VAS), complications according to the Clavien-Dindo system, operative results, number of adjustments, and filling of the system.
Thirty-four patients with median pad test 510 (170-1225) ml were operated on. Preoperative SUI was mild (5.9%), moderate (17.6%), and severe (76.5%). At median 18.5 (12-26) months follow-up distribution of SUI was none (85.3%), mild (8.8%), and moderate (5.9%). Median intraoperative filling was 14 (8-17) ml, number of adjustments 1 (0-5), and total filling 17.5 (11-33.5) ml. At 3 months, median ICIQ-SF (p = 0.0001) and IIQ-7 (p < 0.0001) decreased. At 12 months, 24-h pad count and pad test decreased (both p < 0.0001), residual volume slightly increased (p = 0.018), PGI-I was 1 (1-3), GRA 6 (3-6), and 97% were satisfied with treatment. Continence (p = 0.016) and satisfaction (p = 0.09) were worse in irradiated patients. Median operative time was 67 (35-120) min, hospital stay 1 (1-3) days, and VAS for pain on postoperative day 1 was 0 (0-2). Complications presented in 14.7% (8.8% grade I and 5.9% grade III).
Treatment of severe male SUI after radical prostatectomy with pre-attached scrotal port ATOMS is safe and very effective in the short term. A positive cough test before implant and intraoperative overfilling of the system may optimize patient selection and results.
本研究的目的是报告使用第三代预附着阴囊端口可调节经闭孔男性系统(ATOMS)治疗前列腺癌根治术后男性压力性尿失禁(SUI)的疗效指标。
对连续的患者进行前瞻性开放性研究。评估包括咳嗽试验、尿道镜检查、充盈和排尿膀胱测压、24小时尿垫计数和尿垫试验、患者报告的结果(ICIQ-SF、IIQ-7、PGI、GRA和VAS)、根据Clavien-Dindo系统分类的并发症、手术结果、调整次数以及系统充盈情况。
34例患者接受了手术,尿垫试验中位数为510(170 - 1225)ml。术前SUI为轻度(5.9%)、中度(17.6%)和重度(76.5%)。在中位随访18.5(12 - 26)个月时,SUI分布为无(85.3%)、轻度(8.8%)和中度(5.9%)。术中充盈中位数为14(8 - 17)ml,调整次数为1(0 - 5)次,总充盈量为17.5(11 - 33.5)ml。3个月时,ICIQ-SF中位数(p = 0.0001)和IIQ-7中位数(p < 0.0001)下降。12个月时,24小时尿垫计数和尿垫试验下降(均p < 0.0001),残余尿量略有增加(p = 0.018),PGI-I为1(1 - 3),GRA为6(3 - 6),97%的患者对治疗满意。接受放疗的患者控尿情况(p = 0.016)和满意度(p = 0.09)较差。中位手术时间为67(35 - 120)分钟,住院时间为1(1 - 3)天,术后第1天疼痛的VAS评分为0(0 - 2)。并发症发生率为14.7%(I级8.8%,III级5.9%)。
使用预附着阴囊端口ATOMS治疗前列腺癌根治术后严重男性SUI在短期内是安全且非常有效的。植入前阳性咳嗽试验和术中系统过度充盈可能有助于优化患者选择和治疗效果。