Status:
UNKNOWN
Sequencing and Combination of Mirabegron and TTNS in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Overactive Bladder Syndrome
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 monothera...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05188742
Start Date
November 10 2021
End Date
September 1 2023
Last Update
January 12 2022
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217