Panicker Jalesh N, Seth Jai H, Khan Shahid, Gonzales Gwen, Haslam Collette, Kessler Thomas M, Fowler Clare J
Department of Uro-Neurology, The National Hospital for Neurology and Neurosurgery, University College London (UCL), Institute of Neurology, London, UK.
Neuro-Urology, Spinal Cord Injury Centre, Balgrist University Hospital, University of Zürich, Zürich, Switzerland.
BJU Int. 2016 May;117(5):809-13. doi: 10.1111/bju.13342. Epub 2015 Nov 8.
To assess the efficacy (defined as improvements in maximum urinary flow rate [Qmax ] of ≥50%, post-void residual urine volume [PVR] and scores on the International Prostate Symptom Score [IPSS] questionnaire) and safety of urethral sphincter injections of onabotulinumtoxinA in women with a primary disorder of urethral sphincter relaxation, characterised by an elevated urethral pressure profile (UPP) and specific findings at urethral sphincter electromyography (EMG), i.e. Fowler's syndrome.
In this open-label pilot Institutional Review Board-approved study, 10 women with a primary disorder of urethral sphincter relaxation (elevated UPP, sphincter volume, and abnormal EMG) presenting with obstructed voiding (five) or in complete urinary retention (five) were recruited from a single tertiary referral centre. Baseline symptoms were assessed using the IPSS, and Qmax and PVR were measured. After 2% lidocaine injection, 100 U of onabotulinumtoxinA was injected into the striated urethral sphincter, divided on either side, under EMG guidance. Patients were reviewed at 1, 4 and 10 weeks after injection, and assessed using the IPSS, Qmax and PVR measurements. The UPP was repeated at week 4.
The mean (range) patient age was 40 (25-65) years, and the mean symptom scores on the IPSS improved from 25.6 to 14.1, and the mean 'bother' score reduced from 6.1 to 3.5 at week 10. As compared with a baseline mean Qmax of 8.12 mL/s in the women who could void, the Qmax improved to 15.8 mL/s at week 10. Four of the five women in complete retention could void spontaneously, with a mean Qmax of 14.3 mL/s at week 10. The mean PVR decreased from 260 to 89 mL and the mean static UPP improved from 113 cmH2 O at baseline to 90 cmH2 O. No serious side-effects were reported. Three women with a history of recurrent urinary tract infections developed a urinary tract infection. There were no reports of stress urinary incontinence. Seven of the 10 women opted to return for repeat injections.
This pilot study shows an improvement in patient-reported lower urinary tract symptoms, and the objective parameters of Qmax , PVR and UPP, at 10 weeks after urethral sphincter injections of onabotulinumtoxinA. No serious side-effects were reported. This treatment could represent a safe outpatient treatment for young women in retention due to a primary disorder of urethral sphincter relaxation. However, a larger study is required to confirm the findings of this pilot study.
评估尿道括约肌注射A型肉毒毒素对以尿道压力分布升高（UPP）及尿道括约肌肌电图（EMG）特定表现为特征的原发性尿道括约肌松弛障碍（即福勒综合征）女性患者的疗效（定义为最大尿流率[Qmax]提高≥50%、排尿后残余尿量[PVR]及国际前列腺症状评分[IPSS]问卷得分改善）及安全性。
在这项经机构审查委员会批准的开放标签试点研究中，从单一的三级转诊中心招募了10名原发性尿道括约肌松弛障碍（UPP升高、括约肌容积增大及EMG异常）且存在排尿梗阻（5例）或完全性尿潴留（5例）的女性患者。使用IPSS评估基线症状，并测量Qmax和PVR。在注射2%利多卡因后，在EMG引导下将100 U A型肉毒毒素注射到尿道横纹肌括约肌，分两侧注射。在注射后1周、4周和10周对患者进行复查，并使用IPSS、Qmax和PVR测量进行评估。在第4周重复测量UPP。
患者平均年龄为40（25 - 65）岁，IPSS平均症状评分从25.6改善至14.1，“困扰”平均评分从6.1降至3.5（第10周）。与能够排尿的女性患者基线时平均Qmax 8.12 mL/s相比，第10周时Qmax改善至15.8 mL/s。5例完全性尿潴留女性中有4例能够自主排尿，第10周时平均Qmax为14.3 mL/s。平均PVR从260 mL降至89 mL，平均静态UPP从基线时的113 cmH₂O改善至90 cmH₂O。未报告严重副作用。3例有复发性尿路感染病史的女性发生了尿路感染。无压力性尿失禁报告。10名女性中有7名选择回来接受重复注射。
这项试点研究表明，尿道括约肌注射A型肉毒毒素10周后，患者报告的下尿路症状以及Qmax、PVR和UPP等客观参数均有改善。未报告严重副作用。这种治疗方法可能是因原发性尿道括约肌松弛障碍导致尿潴留的年轻女性的一种安全的门诊治疗方法。然而，需要更大规模的研究来证实这项试点研究的结果。
