Zargham Mahtab, Abedi Shideh, Alizadeh Farshid, Khorami Mohamad Hatef, Mohamadi Mehrdad, Bahrami Faranak, Sharifiaghdas Farzaneh, Mazdak Hamid
Isfahan Kidney Transplantation Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Urology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Adv Biomed Res. 2017 Aug 31;6:113. doi: 10.4103/abr.abr_393_14. eCollection 2017.
Intradetrusor injection of botulinum toxin A (BTX-A) might serve as a minimally invasive substitute in patients with refractory idiopathic overactive bladder (RIOAB). The aim of this study was to evaluate the clinical outcomes related to two different doses of abo-BTX-A (AboBTX-A) in patients with RIOAB.
This prospective clinical trial was performed on 55 women with RIOAB. After determination of trabeculation grade, 300 (no or mild) or 500 (moderate or severe) unit of AboBTX-A (Dysport) was intravesicaly injected. Before 1, 3, and 6 months after intervention, lower urinary tract symptoms during 24 h were recorded.
Of the study population, 62% had severe bladder trabeculation. The mean duration of overactive bladder (OAB) was 1.76 versus 5.85 years, for no or mild versus severe trabeculation, respectively. After injections of 300- and 500-unit dosage, there were 19% and 26% early complications such as urinary retention. There was a statistically significant difference between the two groups in OAB score after 1 month ( < 0.001) and duration of OAB symptoms, over three follow-up times ( < 0.001). The mean preinjection OAB scores between patients with and without recurrence were statistically significant (29.36 vs. 25.07; < 0.03). Urinary tract infection as a late complication was distinguished in four patients.
In RIOAB, by adjusted dosage of AboBTX-A related to the grade of bladder trabeculation, in addition to maintain efficacy, consequent complications might not be affected by dosage and the drug dosage could be increased to nearly 60% with less concern associated to complication.
膀胱逼尿肌内注射A型肉毒杆菌毒素(BTX-A)可能是难治性特发性膀胱过度活动症(RIOAB)患者的一种微创替代疗法。本研究旨在评估两种不同剂量的阿柏西普肉毒杆菌毒素A(AboBTX-A)对RIOAB患者的临床疗效。
对55例RIOAB女性患者进行了这项前瞻性临床试验。在确定小梁分级后,膀胱内注射300(无或轻度)或500(中度或重度)单位的AboBTX-A(Dysport)。在干预前、干预后1个月、3个月和6个月,记录24小时内的下尿路症状。
在研究人群中,62%有严重的膀胱小梁形成。膀胱过度活动症(OAB)的平均病程在无或轻度小梁形成组与严重小梁形成组分别为1.76年和5.85年。注射300单位和500单位剂量后,分别有19%和26%出现早期并发症,如尿潴留。两组在1个月后的OAB评分(<0.001)以及在三个随访时间点的OAB症状持续时间(<0.001)上存在统计学显著差异。复发患者与未复发患者注射前的平均OAB评分具有统计学显著性差异(29.36对25.07;<0.03)。有4例患者出现了作为晚期并发症的尿路感染。
在RIOAB中,根据膀胱小梁分级调整AboBTX-A的剂量,除了维持疗效外,后续并发症可能不受剂量影响,并且药物剂量可以增加近60%,同时较少担心并发症。