Berghmans L C, Frederiks C M, de Bie R A, Weil E H, Smeets L W, van Waalwijk van Doorn E S, Janknegt R A
Department of Urology, University Hospital Maastricht, The Netherlands.
Neurourol Urodyn. 1996;15(1):37-52. doi: 10.1002/(SICI)1520-6777(1996)15:1<37::AID-NAU4>3.0.CO;2-G.
We performed a randomized clinical trial on the efficacy of physical therapy on genuine stress incontinence.
"Is a physical therapeutical training program (pelvic floor muscle training) combined with biofeedback, more effective than the same program without biofeedback in patients with mild or moderate stress incontinence?" Forty-four patients were referred by a general practitioner or a urologist. After informed consent, 40 patients were randomized in an exercises and biofeedback group (BF), or treated with exercises exclusively (pelvic floor muscle training = PFMT). After a diagnostic phase of 1 week every patient received twelve treatment sessions, three times weekly. The primary measure of effect, the quantity of involuntary urine loss, was measured with the 48 hours PAD test (Inco-test Mölnlycke). Before every treatment session the Symptoms questionnaire was filed out by the patient and the Patient dairy was controlled. The data of the trial were analysed according to the principal of intention to treat. During the trial there was 100% compliance. There were no drop-outs. Both treatment modalities appeared to be effective. After twelve treatment sessions there was a mean improvement of +/- 55% (P = 0.00) in both treatment groups, measured by the primary measure of effect. In the group with BF this improvement was already realized after six treatment sessions (P = 0.01). Yet, the difference between BF and PFMT faded to reach significance at six treatment sessions (P = 0.08). Although differences in treatment effects between both groups were not significant, our findings suggest that adding biofeedback to pelvic floor muscle exercises might be more effective than pelvic floor muscle exercises alone after six treatments.
我们进行了一项关于物理治疗真性压力性尿失禁疗效的随机临床试验。
“对于轻度或中度压力性尿失禁患者,结合生物反馈的物理治疗训练方案(盆底肌肉训练)是否比不结合生物反馈的相同方案更有效?”44名患者由全科医生或泌尿科医生转诊。在获得知情同意后,40名患者被随机分为运动和生物反馈组(BF),或仅接受运动治疗(盆底肌肉训练=PFMT)。在为期1周的诊断阶段后,每位患者每周接受三次,共十二次治疗。主要疗效指标,即不自主尿失禁量,通过48小时垫试验(英科测试,莫林阿克)测量。在每次治疗前,患者填写症状问卷并检查患者日记。根据意向性治疗原则分析试验数据。在试验期间,依从率为100%。没有退出者。两种治疗方式似乎都有效。通过主要疗效指标测量,在十二次治疗后,两个治疗组的平均改善率均为+/-55%(P = 0.00)。在BF组中,在六次治疗后就已经实现了这种改善(P = 0.01)。然而,BF组和PFMT组之间的差异在六次治疗时逐渐缩小至无统计学意义(P = 0.08)。虽然两组之间的治疗效果差异不显著,但我们的研究结果表明,在进行六次治疗后,在盆底肌肉锻炼中加入生物反馈可能比单纯的盆底肌肉锻炼更有效。