Adjunctive EMG Biofeedback-Assisted Pelvic Floor Muscle Training in Women With Wet Overactive Bladder and Urodynamically Confirmed Detrusor Overactivity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Daily Voiding Frequency
研究概览
简要总结
Overactive bladder causes a sudden and difficult-to-control need to urinate and may be accompanied by urine leakage. Bladder training is commonly used as a first-line treatment. Pelvic floor muscle training supported by electromyographic biofeedback may help women recognize and contract the correct muscles and improve control of urgency and leakage.
The purpose of this randomized controlled trial was to determine whether adding electromyographic biofeedback-assisted pelvic floor muscle training to bladder training provides additional benefit compared with bladder training alone in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
A total of 64 women were randomly assigned in a 1:1 ratio to receive either bladder training alone or bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training. Both interventions lasted 8 weeks. Participants in the combined intervention group received 24 supervised biofeedback sessions in addition to bladder training.
The primary outcome was the change in daily voiding frequency measured using a 3-day bladder diary. Secondary outcomes included urgency, urgency urinary incontinence, nocturia, incontinence-related quality of life, pelvic floor muscle function, treatment adherence, treatment satisfaction, and adverse events. Outcomes were assessed at baseline and at week 8.
详细描述
This was an assessor-blinded, two-arm, parallel-group randomized controlled trial conducted in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
Eligible participants were randomly assigned in a 1:1 ratio to a bladder training group or a bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training group. All participants received an 8-week bladder training program that included education, counseling on fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies.
Participants assigned to the combined intervention additionally received 24 individually supervised electromyographic biofeedback-assisted pelvic floor muscle training sessions over 8 weeks. Surface perineal electrodes were used to provide visual feedback during pelvic floor muscle contractions. Training included slow and fast pelvic floor muscle contractions under the supervision of the same physiotherapist.
Assessments were performed at baseline and at week 8. The primary outcome was the change in mean daily voiding frequency calculated from a 3-day bladder diary. Secondary outcomes included daily urgency episodes, urgency urinary incontinence episodes, nocturia episodes, daily fluid intake, incontinence-related quality of life, the impact of urinary incontinence on daily activities, pelvic floor muscle strength, treatment satisfaction, intervention adherence, and adverse events.
The urologist performing the follow-up outcome assessments was blinded to treatment allocation. Participants and the treating physiotherapist could not be blinded because of the nature of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The urologist who performed the week-8 follow-up outcome assessments was blinded to group allocation. Participants and the treating physiotherapist could not be blinded because of the nature of the interventions. Participants were instructed not to disclose their assigned group during outcome assessments.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 years or older
- •Presence of wet overactive bladder symptoms
- •Detrusor overactivity confirmed by urodynamic testing
- •Pelvic floor muscle strength of at least 3/5 according to the Modified Oxford Scale
- •Ability to comply with the study procedures and complete the bladder diary
排除标准
- •Neurogenic bladder
- •Active urinary tract infection or vulvovaginitis
- •Pregnancy or planning pregnancy
- •Urogynecological surgery within the previous 3 months
- •Pelvic organ prolapse stage 2 or higher according to the Pelvic Organ Prolapse Quantification system
- •Presence of a pacemaker or implantable defibrillator
- •Recent conservative or pharmacological treatment for overactive bladder
结局指标
主要结局
Change From Baseline in Mean Daily Voiding Frequency
时间窗: Baseline and week 8
Mean daily voiding frequency was calculated as the mean number of voids per day recorded in a 3-day bladder diary. Change was calculated as the week-8 value minus the baseline value. Negative change values indicate a reduction in daily voiding frequency.
次要结局
- Change From Baseline in Mean Daily Urgency Episodes(Baseline and week 8)
- Change From Baseline in Mean Daily Urgency Urinary Incontinence Episodes(Baseline and week 8)
- Change From Baseline in Mean Nightly Nocturia Episodes(Baseline and week 8)
- Change From Baseline in Mean Daily Fluid Intake(Baseline and week 8)
- Change From Baseline in Incontinence Quality of Life Questionnaire Total Score(Baseline and week 8)
- Change From Baseline in Incontinence Impact Questionnaire-7 Total Score(Baseline and week 8)
- Change From Baseline in Modified Oxford Scale Score(Baseline and week 8)
- Treatment Satisfaction Score(Week 8)
- Number of Participants Who Completed the Treatment Program(Week 8)
- Number of Participants Who Completed the Week-8 Bladder Diary(Week 8)
- Number of EMG Biofeedback Sessions Attended(Throughout the 8-week intervention period)
- Number of Participants With Adequate EMG Biofeedback Session Adherence(Throughout the 8-week intervention period)
- Number of Participants With Adverse Events(From baseline through week 8)
研究者
Bengisu Tüfekçi
Assistant Professor
Gaziantep Islam Science and Technology University