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Preventive Effects of Vibegron on Ureteral Stent-Related Symptoms

An Open-Label, Randomized, Controlled Exploratory Trial Evaluating the Preventive Effects of Vibegron on Ureteral Stent-Related Symptoms

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061240140
Enrollment
100
Registered
2025-03-24
Start date
2025-05-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing new ureteral stenting for upper urinary tract stenosis stent-related symptoms, overactive bladder, ureteral stent

Interventions

Vibegron group: Vibegron 50 mg will be administered orally once daily starting from the day of ureteral stent placement. The duration of administration will, in principle, correspond to the duration o
Administration, Oral

Sponsors

Hinata Nobuyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who will receive a new ureteral stent for upper urinary tract stenosis due to urinary lithiasis, malignancy, or transurethral lithotripsy (TUL) for urinary tract lithiasis 2) Patients who are 18 years of age or older at the time of consent 3) Patients who are able to complete the questionnaire 4) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on their full understanding of the study.

Exclusion criteria

Exclusion criteria: 1) Patients with bladder catheter in place prior to ureteral stenting 2) Patients with spinal cord paralysis or sensory insensitivity below the thoracic spinal cord 3) Patients with preoperative uncontrolled urinary tract infection 4) Patients with a diagnosis of dementia 5) Patients on medical therapy for benign prostatic hyperplasia 6) Patients on medical therapy for overactive bladder (OAB) 7) Patients on regular analgesic medication 8) Patients with a history of prior radiation therapy to pelvic organs 9) Patients undergoing bilateral ureteral stenting 10) Patients with serious cardiac disease or severe hepatic disorder 11) Patients with a history of hypersensitivity to any component of Vivegron 12) Other patients deemed inappropriate by the principal investigator or subinvestigator.

Design outcomes

Primary

MeasureTime frame
1) Change from baseline in Overactive Bladder Symptom Score (OABSS) at 2 weeks after ureteral stenting 2) Change from baseline in pain symptom scale (Visual analog scale: VAS) at 2 weeks after ureteral stenting

Secondary

MeasureTime frame
1) Change from baseline in Overactive Bladder Symptom Score (OABSS) at the defined time point 2) Change from baseline in International Prostate Symptom Scor (IPSS) at the specified time point 3) Change from baseline in pain symptom scale (Visual analog scale: VAS) at defined time points 4) Number of analgesics (e.g., acetaminophen) 5) Percentage of adverse events

Contacts

Public ContactYuki Kohada

Hiroshima University Hospital

ykohada@hiroshima-u.ac.jp+81-82-257-5242

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026