Selective Bladder Denervation Vs Intramuscular Onabotulinum Toxin a for Refractory Overactive Bladder: a Randomized Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Overactive Bladder Assessment Tool (OAB-V8) Total Score at 12 Weeks
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness and safety of two treatments for refractory overactive bladder in adult women.
The main questions it aims to answer are:
- Does selective bladder denervation using radiofrequency ablation improve overactive bladder symptoms more effectively than intravesical Onabotulinum toxin A injections?
- What are the safety profiles of each treatment?
Researchers will compare selective bladder denervation using radiofrequency ablation to intravesical Onabotulinum toxin A injections to determine which treatment is more effective and tolerable for patients whose symptoms persist despite behavioral and medical therapies.
Participants will:
- Be women aged 18 and older diagnosed with overactive bladder who did not benefit from at least two prior medical treatments for 3 months or were unable to tolerate those treatments.
- Be randomly assigned to receive either radiofrequency ablation or Onabotulinum toxin A treatment.
- Attend follow-up visits at weeks 2, 4, and 12 over a 3-month period, during which symptom improvement will be assessed using validated questionnaires and side effects will be monitored through imaging, blood, and urine tests.
详细描述
This randomized clinical trial aims to evaluate the effectiveness and safety of two third-line treatment options for women with refractory overactive bladder syndrome: selective bladder denervation using radiofrequency ablation and intravesical Onabotulinum toxin A injection.
The study includes 60 symptomatic female patients aged 18 years and older who met the eligibility criteria and had either failed to achieve adequate symptom control with at least two different oral pharmacological treatments or were unable to tolerate such therapies. Participants were randomly assigned into two equal groups, with 30 patients in each group, using the "Research Randomizer" tool.
Participant Assessments:
At the initial assessment, all participants underwent the following evaluations:
- A detailed medical history, including past surgeries and prior medication use.
- Urinary tests, including urinalysis and urine culture, as well as blood biochemical evaluations.
- Imaging with urinary system ultrasonography to evaluate both the upper and lower urinary tract and measure post-void residual urine volume.
- Symptom assessment using the following validated patient-reported outcome questionnaires:
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
- •Biological females aged 18 years or older.
- •Diagnosis of refractory overactive bladder syndrome, defined as:
- •Persistent symptoms despite having completed behavioral therapy and at least two different oral pharmacotherapies (e.g., anticholinergics or beta-3 adrenergic agonists) for a minimum of 3 months each; or
- •Inability to tolerate oral pharmacotherapy for overactive bladder syndrome. Willingness and ability to provide written informed consent. Ability to comply with the study protocol, including attendance at scheduled follow-up visits and completion of validated symptom assessment questionnaires (e.g., Overactive Bladder Symptom Score - OAB-V8, International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms - ICIQ-FLUTS).
排除标准
- •Pregnancy or intention to become pregnant within 12 months of enrollment. History of stress urinary incontinence as the predominant symptom.
- •Recent interventions prior to enrollment:
- •Oral medication for overactive bladder within the past 2 weeks.
- •Intravesical Onabotulinum toxin A injection within the past 9 months.
- •Pelvic electrical stimulation within the past 2 weeks. Active or chronic urinary tract infection or a history of urinary retention within the past 6 months.
- •Active hematuria or known bleeding disorders.
- •History or current diagnosis of:
- •Bladder cancer or ongoing bladder cancer treatment.
- •Bladder outlet obstruction, ureteral dysfunction, ureteral stricture, or vesicoureteral reflux.
- •Elevated serum creatinine level (≥2 times the upper limit of normal) within the past 6 months.
- •Neurological conditions affecting bladder function, including but not limited to:
- •Multiple sclerosis.
- •Myasthenia gravis.
- •Spinal cord injury or disease. Any condition deemed by the investigator to interfere with study participation or accurate evaluation of outcomes.
研究组 & 干预措施
Selective Bladder Denervation via Radiofrequency Ablation
Participants in this arm will undergo selective bladder denervation using a radiofrequency ablation procedure. This minimally invasive treatment involves applying controlled radiofrequency energy at four submucosal points in the bladder trigone area under general anesthesia. The procedure aims to reduce nerve overactivity and improve symptoms of refractory overactive bladder. Follow-up assessments will evaluate symptom improvement, safety, and quality of life over a 3-month period.
干预措施: Selective Bladder Denervation via Radiofrequency Ablation (Device)
Intravesical Onabotulinum Toxin A Injection
Participants in this arm will receive intravesical injections of Onabotulinum toxin A. A total of 100 units will be injected into 10 sites on the bladder wall under local anesthesia. This intervention is an established third-line treatment for refractory overactive bladder, aimed at reducing bladder overactivity. Symptom improvement, safety, and quality of life will be assessed during follow-up visits over a 3-month period.
干预措施: Intravesical Onabotulinum Toxin A Injection (Drug)
结局指标
主要结局
Change from Baseline in Overactive Bladder Assessment Tool (OAB-V8) Total Score at 12 Weeks
时间窗: From baseline to 12 weeks post-treatment
The Overactive Bladder Assessment Tool (OAB-V8) is an 8-item validated questionnaire used to assess the severity of overactive bladder (OAB) symptoms, including urinary urgency, frequency, nocturia, and urge urinary incontinence. Each item is rated on a 6-point Likert scale from 0 (not at all) to 5 (a very severe problem), resulting in a total score ranging from 0 to 40, with higher scores indicating greater symptom severity. The primary outcome of this study is the change from baseline in OAB-V8 total score at 12 weeks. A clinically significant response is defined as a ≥50% reduction in total OAB-V8 score compared to baseline.
次要结局
- Change from Baseline in International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICQ-FLUTS) Score at 12 Weeks(From baseline to 12 weeks post-treatment)
- Change from Baseline in Incontinence Quality of Life (I-QOL) Score at 12 Weeks(From baseline to 12 weeks post-treatment)
- Change from Baseline in Urgency and Urgency Urinary Incontinence (UUI) Episodes at 12 Weeks(From baseline to 12 weeks post-treatment)
- Incidence of Treatment-Related Adverse Events at 12 Weeks(From baseline to 12 weeks post-treatment)