Patients with residual overactive bladder symptoms following transurethral Prostatic Urethral Lift
Conditions
Interventions
Take 50 mg of Vibegron once daily after meals
Sponsors
Waseda Yuma
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be enrolled in this clinical study: 1. Patients aged 18 years or older at the time of consent acquisition 2. Patients diagnosed with OAB*2 based on the Overactive Bladder Symptom Score (OABSS) at 6 weeks*1 post-transurethral Prostatic Urethral Lift (UroLift) for BPH, and who also experience frequent urination*3 *1:6 weeks +- 2 weeks is acceptable. The same applies below. *2:Urge urgency score of 2 points or higher on the OABSS, and total OABSS score of 3 points or higher *3:24-hour urinary frequency >- 8 times 3. Patients with the willingness and ability to accurately complete a voiding diary and questionnaires, including 3 days of urine volume measurement 4. Patients willing and able to comply with the study protocol, including study visits and examinations 5. Patients who have fully understood the study content and provided written informed consent
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this clinical study: 1. Patients who were already taking*2 OAB medication at 6 weeks*1 post-surgery *2:Patients who took OAB medication preoperatively but discontinued it postoperatively are eligible for enrollment. 2. Patients taking alpha-1 blockers within 2 weeks prior to enrollment 3. Patients with clinically significant bladder outlet obstruction 4. Patients with high residual urine volume (residual volume exceeding 100 ml at least once during post-operative residual urine measurements within 6 weeks) 5. Patients with a continuously indwelling urinary catheter or performing intermittent self-catheterization 6. Patients undergoing non-pharmacological treatments for urinary incontinence, including sacral nerve stimulation therapy. However, bladder training programs or pelvic floor muscle exercises initiated more than 30 days prior to registration are permissible. 7. Patients judged by the principal (or sub-principal) investigator to have a disease or surgical history that could affect urinary assessment for OAB (e.g., patients who underwent intravesical Botulinum Toxin A injection). 8. Patients with chronic inflammatory disease or malignant disease* within the pelvis. *Patients who have undergone intravesical therapy for bladder malignancy within the past 12 months. However, patients who are cancer-free and have had no recurrence for one year are eligible for enrollment. 9. Patients with a history of hypersensitivity to any component of Vibegron. 10. Other patients deemed unsuitable for participation in this study by the principal investigator (or co-investigator) for medical, psychological, or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in daily urinary frequency at 12 weeks after initiation of protocol treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in daily urinary frequency at 4 and 8 weeks after protocol initiation 2. Change in daytime urinary frequency at 4, 8, and 12 weeks after protocol initiation 3. Change in nocturnal urinary frequency at 4, 8, and 12 weeks after protocol initiation 4. Change in daily urinary incontinence episodes at 4, 8, and 12 weeks after protocol treatment initiation 5. Change in each OABSS score and total OABSS score at 4, 8, and 12 weeks after protocol treatment initiation 6. Change in each IPSS/QOL score and total IPSS/QOL score at 4, 8, and 12 weeks after protocol treatment initiation 7. Change in maximum urinary flow rate (Qmax) at 4, 8, and 12 weeks after protocol treatment initiation | — |
Contacts
Public ContactYuma Waseda
Institute of Science Tokyo Hospital
Outcome results
None listed