Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women.
The main questions this study aims to answer are whether Li-SWT improves overactive bladder symptoms and quality of life, and whether these improvements are sustained over a 12-month follow-up period, compared with standard medical therapy.
Researchers will compare Li-SWT with oral solifenacin succinate, a commonly used antimuscarinic medication for OAB.
Participants will be randomly assigned to receive either Li-SWT once weekly for 8 weeks or solifenacin 5 mg taken orally once daily for 12 months. All participants will complete symptom questionnaires and three-day voiding diaries and will undergo uroflowmetry, post-void residual measurement, and filling cystometry at specified time points during follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •OAB symptoms persisting for ≥3 months.
- •OAB Symptom Score (OABSS) ≥
- •Ability and willingness to provide informed consent
排除标准
- •Active urinary tract infection.
- •Stress urinary incontinence as primary diagnosis.
- •Pelvic organ prolapse stage ≥II.
- •History of pelvic radiation or surgery within 6 months.
- •Use of anticholinergics or β3-agonists for the past 4 weeks who are unwilling to undergo washout.
- •Pregnancy or breast feeding.
- •Neuropathic diseases or psychological disorders.
- •History of urogenital malignancy.
- •Uncontrolled DM (HbA1c > 6.8)
- •Uncorrected coagulopathy or severe cardiovascular disease.
- •Contraindication to solifenacin e.g.: closed angle glaucoma)
研究组 & 干预措施
Solifenacin Group
Allocated to receive oral Solifenacin succinate 5 mg
干预措施: Oral Solifenacin succinate 5 mg (Drug)
LiSWT group
Allocated to receive LiSWT
干预措施: Low intensity shockwave therapy (Other)
结局指标
主要结局
Changes in Overactive Bladder Symptom Score (OABSS) from baseline to different points of follow up
时间窗: Baseline and 3 months
self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms
次要结局
- Changes in frequency on three-day urinary diary(from baseline to 1, 3, 6,9 and 12 months)
- Changes in number of urgency episodes on three-day urinary diary(baseline to 1, 2, 3,6,9 and 12 months)
- Changes in number of nocturia episodes on three-day urinary diary(baseline to 1, 2, 3,6,9 and 12 months)
- Changes in number of incontinence episodes on three-day urinary diary(form baseline to 1,2,3,6,9 and 12 months)
- changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score(form baseline to 1,2,3,6,9 and 12 months)
- changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)(from baseline to 1,2,3,6,9 and 12 months)