Sequencing and Combination of Mirabegron and Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
研究概览
简要总结
Research question:
A wealth of existing research has established the independent effectiveness of mirabegron and neuromodulation in the treatment of overactive bladder syndrome. Optimizing the use of these effective and well-tolerated treatment modalities is an important clinical goal and warrants further research. The primary aim of this trial is to answer the questions: how does varying the treatment sequence involving mirabegron and transcutaneous tibial nerve stimulation (TTNS) affect efficacy and patient acceptance and what is the second-line efficacy of either treatment modality?
Primary objective:
To evaluate improvement in storage symptoms, as measured by changes in Overactive Bladder Symptom Score (OABSS), International Prostate Symptom Score (IPSS) and parameters of voiding diary, in overactive bladder (OAB) patients receiving mirabegron or TTNS as first-line therapy when crossed over to second-line therapy with the opposite treatment modality
Secondary objectives:
To evaluate improvement in symptoms, as measured by changes in OABSS, IPSS and parameters of voiding diary, on first-line therapy with mirabegron or TTNS followed by combination multi-modal therapy To evaluate the effect of multi-modal treatment approach on patient's perception of treatment satisfaction and symptom control To evaluate urodynamic profiles of patients treated with multi-modal approach
详细描述
Study design: Prospective, randomized, multicenter, open-label, cross-over trial Treatment sequence: randomized with 1:1 ratio to either Sequence A or Sequence B
Sequence A: mirabegron 50mg monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> TTNS monotherapy x 8 weeks Sequence B: TTNS monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> mirabegron 50mg monotherapy x 8 weeks
Patient population: adults ≥ 20 years who have experienced symptoms of OAB, as defined by International Continence Society (ICS) diagnostic criteria, for at least 3 months
Sample size: approximately 180 patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult OAB patients ≥20 years
- •Diagnosed with moderate to severe OAB (with or without urgency incontinence) based on OABSS >5 and clinical assessment, with UUI-predominant presentation, for at least 3 months
- •Able to receive TTNS and accommodate treatment logistics (30 min per on-site session, twice weekly)
- •Provided informed consent to participate in the study
排除标准
- •Neurologic conditions associated with OAB symptoms
- •History of stress urinary incontinence
- •Use of intravesical onabotulinumoxinA within recent 6 months
- •Postvoid residual urine volume (PVR) ≥ 100mL
- •Evidence of active urinary tract infection or urinary tract stone at screening
- •Genitourinary tract operation during the 3-month period prior to baseline
- •Confirmed or suspected genitourinary tract or pelvic malignancy
- •History of uncontrolled hypertension (systolic >160 mmHg and/or diastolic >110 mmHg)
- •History of intolerance to mirabegron
- •Patients with pacemakers or implantable defibrillators
- •Patients prone to excessive bleeding
- •Patients with nerve damage that could impact percutaneous tibial nerve or pelvic floor function
- •Patients who are pregnant or planning to become pregnant during the duration of treatment
- •History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study protocol
研究组 & 干预措施
Sequence A
mirabegron 50mg OD x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by TTNS twice a week x 8 weeks
干预措施: mirabegron (Drug)
Sequence A
mirabegron 50mg OD x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by TTNS twice a week x 8 weeks
干预措施: TTNS (Procedure)
Sequence B
TTNS twice a week x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by mirabegron 50mg OD x 8 weeks
干预措施: mirabegron (Drug)
Sequence B
TTNS twice a week x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by mirabegron 50mg OD x 8 weeks
干预措施: TTNS (Procedure)
结局指标
主要结局
Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
时间窗: Baseline and Week 20
Changes from baseline to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome). Symptom improvement is defined as OABSS total score decreased by ≥ 3 points at EoT
次要结局
- Changes from baseline to Week 12 and 20/end of treatment (EoT) in IPSS(Baseline, and Week 12 and 20)
- Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Micturitions per 24 Hours(Baseline, and Week 12 and 20)
- Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Incontinence Episodes per 24 Hours(Baseline, and Week 12 and 20)
- Changes from Week 8 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours(Week 8 to Week 20)
- Changes from Week 12 to Week 20 in IPSS(Week 12 to Week 20)
- Changes from Week 12 to Week 20 in Mean Number of Micturitions per 24 Hours(Week 12 to Week 20)
- Changes from baseline to Week 12 and 20/end of treatment (EoT) in Bladder Assessment Tool (BAT) score(Baseline, and Week 12 and 20)
- Changes from baseline to Week 12 in OABSS(Baseline and Week 12)
- Changes from Week 12 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours(Week 12 to Week 20)
- Changes from baseline to Week 12 and 20/end of treatment (EoT) in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score(Baseline, and Week 12 and 20)
- Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Nocturia Episodes per 24 Hours(Baseline, and Week 12 and 20)
- Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Episodes per 24 Hours(Baseline, and Week 12 and 20)
- Changes from Week 8 to Week 20 in OABSS(Week 8 to Week 20)
- Changes from Week 12 to Week 20 in Mean Number of Urgency Episodes per 24 Hours(Week 12 to Week 20)
- Changes from baseline to Week 12 and 20/end of treatment (EoT) in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score(Baseline, and Week 12 and 20)
- Changes from Week 8 to Week 20 in IPSS(Week 8 to Week 20)
- Changes from Week 8 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours(Week 8 to Week 20)
- Changes from Week 8 to Week 20 in Mean Number of Urgency Episodes per 24 Hours(Week 8 to Week 20)
- Changes from Week 8 to Week 20 in Mean Number of Micturitions per 24 Hours(Week 8 to Week 20)
- Changes from Week 12 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours(Week 12 to Week 20)
- Changes from Week 12 to Week 20 in OABSS(Week 12 to Week 20)