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The efficacy and safety of intravesical electrical stimulation combined with a training for bladder motor sensory dysfunction in the treatment of neurogenic underactive bladder / 中华泌尿外科杂志
Chinese Journal of Urology ; (12): 740-746, 2021.
Article in Chinese | WPRIM | ID: wpr-911107
ABSTRACT

Objective:

To explore the efficacy and safety of intravesical electrical stimulation (IVES) combined with a training for bladder motor and sensory dysfunction in the treatment of neurogenic underactive bladder(UAB).

Methods:

A prospective, single-blind, randomized controlled trial was used to study neurogenic UAB patients admitted to the China Rehabilitation Research Center from October 2019 to May 2021. Inclusive criteria included age≥18 years old, the patients who have been diagnosed as neurogenic UAB and the course of disease being more than 3 months; patients who have been undergone intermittent catheterization to empty the bladder or patients indicated for intermittent catheterization (post-void residual urine accounts for more than 40% of the functional bladder volume), voluntary signing of written informed consent, able to communicate well with researchers and comply with the requirements of the whole trial, and the patient not undergoing any treatment other than oral medication before IVES. Exclusion criteria included patients with low bladder compliance by urodynamic examination(<20 ml/cmH 2O), patients with mechanical outflow obstruction, patients with complete spinal cord injury, the patients with symptomatic urinary tract infection which was not cured, patients with hydronephrosis or bladder-ureteral reflux, patients with renal insufficiency(serum creatinine greater than 1.5 times of the upper limit of normality), patients with malignant tumors of the bladder or prostate, overactive bladder, Alzheimer's disease, brain atrophy, acute cerebrovascular disease, or cognitive impairment, patients who were pregnant or planning to be pregnant, bladder mucosa injury, patients with pacemakers or defibrillators, those who participated in other clinical trials 3 months before the study, and other circumstances that the researcher consider it is not suitable to be involved in this study. The patients were randomly divided into experimental group and control group according to the ratio of 1∶1. The experimental group used conventional transurethral insertion of bipolar catheter electrodes for IVES combined with bladder motor and sensory dysfunction training, and the control group underwent IVES with open circuit combined with bladder motor and sensory dysfunction training. The stimulation parameters of the two groups were two-way square wave, 1-30 mA intensity, 10-20 Hz frequency, 200 μs pulse width, once a day, lasting 30 minutes for each treatment, and for continuous 20 working days. The post-void residual urine, voiding efficiency, 24-hour intermittent catheterization times, first sensation of bladder filling volume and American Urological Association Symptom Index Quality of Life(AUA-SI-QOL) scores were recorded before and at the end of treatment. The adverse events during the treatment were recorded.

Results:

Fifty-two patients were selected and 50 patients completed the trial, including 26 patients in the experimental group and 24 patients in the control group. Before treatment, there were no significant differences in gender[16(male)/10(female)vs.13(male)/11(female), P=0.598], age [(40.7±13.5)years vs.(38.5±12.3)years, P=0.543], course of disease[0.71(0.42, 1.63)years vs.0.79(0.42, 1.50)years, P=0.695], post-void residual urine[300(193, 400)ml vs.325(178, 380)ml, P=0.724], voiding efficiency[17%(0, 47.8)% vs.21%(0, 38.0)%, P=0.960], 24-hour intermittent catheterization times[4(2, 4)vs.3(2, 4), P=0.692], first sensation volume during bladder filling[(325.8±74.3)ml vs.(307.5±75.0)ml, P=0.391] or AUA-SI-QOL scores[5(4, 5)vs.4(4, 5), P=0.313] between the experimental group and the control group. At the end of treatment, the post-void residual urine, first sensation volume during bladder filling and AUA-SI-QOL scores of the experimental group were significantly lower than those of the control group [250(40, 350)ml vs.300(200, 390)ml, P=0.034; (276.5±68.8)ml vs.(315.4±67.3)ml, P=0.049; 4(2, 4)vs.4(3, 5), P=0.024], and the voiding efficiency was significantly higher than that of the control group[33%(14.5, 84.5)% vs.18%(0, 35.8)%, P=0.041], but there was no significant difference in the number of 24-hour intermittent catheterization between the two groups [3(1, 4)vs.3(2, 4), P=0.174]. In the control group, there were no significant changes in post-void residual urine, voiding efficiency, 24-hour intermittent catheterization times, first sensation volume during bladder filling and AUA-SI-QOL scores before and after treatment [325(178, 380)ml vs.300(200, 390)ml, P=0.832; 21%(0, 38.0)% vs.18%(0, 35.8)%, P=0.943; 3(2, 4)vs.3(2, 4), P=0.239; (307.5±75.0)ml vs.(315.4±67.3)ml, P=0.257; 4(4, 5)vs.4(3, 5), P=0.157]. In the experimental group, there were significant improvements in post-void residual urine, voiding efficiency, 24-hour intermittent catheterization times, first sensation volume during bladder filling and AUA-SI-QOL scores before and after treatment [300(193, 400)ml vs.250(40, 350)ml, P<0.001; 17%(0, 47.8)% vs.33%(14.5, 84.5)%, P<0.001; 4(2, 4)vs.3(1, 4), P=0.011; (325.8±74.3)ml vs.(276.5±68.8)ml, P<0.001; 5(4, 5)vs.4(2, 4), P<0.001]. During the treatment period, 1 case of abdominal discomfort occurred in the experimental group and 1 case of urethral discomfort in the control group. After adjusting the stimulation intensity and catheter position, the discomfort disappeared without other serious adverse events.

Conclusions:

IVES combined with bladder motor sensory dysfunction training can not only effectively improve the bladder emptying efficiency and bladder sensation in patients with neurogenic UAB, but also be safe and easy to operate.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of Urology Year: 2021 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Controlled clinical trial Language: Chinese Journal: Chinese Journal of Urology Year: 2021 Type: Article