Martan A, Mašata J, Švabík K, El-Haddad R, Hubka P, Krhut J
Ceska Gynekol. 2015 Jan;80(1):25-9.
The objective of this study was to evaluate the cure effect of a transurethral injection of Bulkamid® for recurrent female stress and mixed urinary incontinence in women who had undergone failed tape surgery. Our hypothesis was that cure effect of Bulkamid® is positive in patients when previous tape anti-incontinence surgery has been unsuccessful.
Retrospective clinical study.
Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University and General Faculty Hospital in Prague.
This retrospective study featured 34 patients with recurrent urinary incontinence (SUI: 28, mixed: 6 - predominant symptom was SUI) after unsuccessful tape anti-incontinence surgery. 25 of the patients had undergone anti-incontinence surgery more than once. The cure effect of a transurethral injection of Bulkamid® was evaluated an average of 29 months after the surgery; the minimum period after surgery was 6 months. Subjective assessment of the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short form (ICIQ-UI SF) filled in before and after surgery. An improvement in urinary incontinence was defined as a drop in the score of more than 50%. Objective assessment of leakage of urine was assessed by cough test. The cure effect was evaluated by VAS (Visual Analogue Scale) score and by using the five-point Likert score. Ethical committee approval was obtained, and all subjects gave written informed consent to participate in the study.
The mean age of patients was 71.03 years, mean body mass index (BMI) 29.12 and mean parity 1.91. The cough test showed that 4/34 (11.8%) of patients had negative results for this test after the operation. The ICIQ-UI SF questionnaire showed that 14/34 (41.2%) of our patients were dry or improved after surgery. The mean VAS score was 62.4 after the operation. The Likert score was 4 or 5 (cured or improved) after the operation for 88.2% of patients.
Our hypothesis that the cure effect of Bulkamid® operation would be positive in patients who have undergone previous unsuccessful tape anti-incontinence surgery was partially confirmed. The Likert and VAS scores indicate that the effect of Bulkamid® surgery is good; however, an evaluation of the cure effect of this procedure based on the ICIQ-UI SF score is less positive. This kind of operation, which is minimally invasive, is less arduous for patients, and it is also suitable for patients who have refused further surgical treatment.
本研究的目的是评估经尿道注射Bulkamid®治疗复发性女性压力性和混合性尿失禁的疗效,这些女性患者此前接受的吊带手术失败。我们的假设是,对于既往吊带抗尿失禁手术失败的患者,Bulkamid®的治疗效果是积极的。
回顾性临床研究。
布拉格查理大学第一医学院妇产科及综合医院。
本回顾性研究纳入了34例吊带抗尿失禁手术失败后出现复发性尿失禁的患者(压力性尿失禁:28例,混合性尿失禁:6例——主要症状为压力性尿失禁)。其中25例患者接受过不止一次抗尿失禁手术。经尿道注射Bulkamid®的治疗效果在手术后平均29个月进行评估;手术后最短时间为6个月。基于手术前后填写的《国际尿失禁咨询问卷简表》(ICIQ-UI SF)对尿液漏出情况进行主观评估。尿失禁改善定义为得分下降超过50%。通过咳嗽试验对尿液漏出情况进行客观评估。通过视觉模拟量表(VAS)评分和五点李克特评分对治疗效果进行评估。获得了伦理委员会批准,所有受试者均签署了书面知情同意书以参与本研究。
患者的平均年龄为71.03岁,平均体重指数(BMI)为29.12,平均产次为1.91。咳嗽试验显示,4/34(11.8%)的患者术后该试验结果为阴性。ICIQ-UI SF问卷显示,14/34(41.2%)的患者术后无尿失禁或症状改善。术后平均VAS评分为62.4。88.2%的患者术后李克特评分为4或5分(治愈或改善)。
我们的假设,即Bulkamid®手术对于既往吊带抗尿失禁手术失败的患者治疗效果为阳性,得到了部分证实。李克特评分和VAS评分表明Bulkamid®手术效果良好;然而,基于ICIQ-UI SF评分对该手术治疗效果的评估则不那么乐观。这种手术为微创手术,对患者负担较小,也适用于拒绝进一步手术治疗的患者。