Therapeutic Effects of Low-Intensity Extracorporeal Shock Wave Therapy on Refractory Overactive Bladder Symptoms in Females
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overactive Bladder Questionnaire 8-Item Total Score
研究概览
简要总结
Overactive bladder is a condition characterized by a sudden and difficult-to-control need to urinate, which may occur with frequent urination, nighttime urination, and urine leakage. Some women continue to experience these symptoms despite lifestyle changes, behavioral therapy, and medication, or they cannot tolerate or decline medical treatment.
This study will evaluate whether low-intensity extracorporeal shock wave therapy (Li-ESWT), a non-surgical treatment delivered externally over the lower abdomen, can safely improve refractory overactive bladder symptoms in women.
A total of 40 women will be randomly assigned in equal numbers to receive either active Li-ESWT or a sham treatment. Both groups will attend one treatment session each week for six weeks. The sham procedure will be similar to the active treatment in positioning, session duration, and device sound but will not deliver shock wave energy.
Symptoms will be assessed using the validated Arabic version of the 8-item Overactive Bladder Questionnaire (OAB-V8) before treatment and during follow-up. The main purpose of the study is to compare the change in OAB-V8 symptom score between the two groups after one month. Additional assessments at three months will include post-void residual urine volume, information from a 3-day voiding diary, the participant's overall impression of improvement, and any treatment-related adverse events.
The study hypothesis is that Li-ESWT will improve overactive bladder symptoms and quality of life compared with sham treatment.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be unaware of treatment allocation. The sham procedure will reproduce the active treatment positioning, session duration, and device sound but will not deliver shock wave energy. The urologist administering the intervention will not be masked because the active and sham procedures require different device settings. Randomization codes will be concealed using sealed opaque envelopes prepared by an independent third party not involved in participant recruitment or outcome assessment.
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 to 70 years.
- •Symptoms of overactive bladder with an Overactive Bladder Questionnaire 8-Item total score greater than
- •Failure of behavioral therapy and medical treatment for overactive bladder.
- •Refusal of medical treatment for overactive bladder. Ability to understand the study procedures and provide written informed consent.
排除标准
- •Current use of medical treatment for overactive bladder.
- •Cardiac pacemaker or metallic implant in the treatment area.
- •Coagulation disorder or use of anticoagulants that cannot be temporarily discontinued.
- •Active urinary tract infection; participants may be reconsidered after successful treatment and recovery.
- •Urinary bladder stones.
- •Post-void residual urine volume greater than 100 mL.
- •Lower urinary tract surgery within the previous 6 months.
- •Previous pelvic radiation therapy.
- •History of neuropathic disease.
- •Pregnancy or planning to become pregnant.
- •Hepatic, renal, or cardiac impairment.
结局指标
主要结局
Overactive Bladder Questionnaire 8-Item Total Score
时间窗: Baseline and 1 month after completion of the 6-week treatment
The Arabic-validated Overactive Bladder Questionnaire 8-Item (OAB-V8) will be completed at baseline and 1 month after completion of treatment. The questionnaire contains 8 items scored from 0 to 5, giving a total score ranging from 0 to 40. Higher scores indicate greater symptom-related bother. The outcome will be calculated as the change in total OAB-V8 score from baseline to the 1-month assessment.
次要结局
- Post-Void Residual Urine Volume at 3 Months(Baseline and 3 months after completion of treatment)
- Urinary Frequency Recorded in a 3-Day Voiding Diary(Baseline and 3 months after completion of treatment)
- Mean Voided Urine Volume Recorded in a 3-Day Voiding Diary(Baseline and 3 months after completion of treatment)
- Urgency Level Recorded in a 3-Day Voiding Diary(Baseline and 3 months after completion of treatment)
- Urinary Leakage Episodes Recorded in a 3-Day Voiding Diary(Baseline and 3 months after completion of treatment)
- Functional Bladder Capacity(Baseline and 3 months after completion of treatment)
研究者
Abdelrahman Farid Adam Senosy
Resident of Urology
Al-Azhar University