ADVISR trial

JRCT ID: jRCTs031240134

Registered date:03/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: overactive bladder (OAB) patients with residual OAB symptoms after receiving anticholinergic drugs
• Date of first enrollment: 14/06/2024
• Target sample size: 110
• Study type: Interventional

Intervention(s)

[Combination group] Vibegron 50mg (orally administered once a day after meals) is used in combination with the anticholinergic drug used before registration.
[Switch group] The anticholinergic drug used before registration is discontinued and the patient is switched to vibegron 50 mg (orally administered once a day after meals).

Outcome(s)

• Primary Outcome: Comparison of changes in daily urination frequency at 12 weeks after the start of protocol treatment between the combination group and the switching group

Secondary Outcome

1)Intergroup comparison of changes in daily urination frequency at 4 and 8 weeks after the start of protocol treatment between the combination group and the switching group
2)Intergroup comparison of changes in daytime urination frequency at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
3)Intergroup comparison of changes in nighttime urination frequency at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
4)Intergroup comparison of changes in daily urinary incontinence frequency at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
5)Intergroup comparison of changes in each OABSS score and total score at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
6)Intergroup comparison of changes in each IPSS/QOL score and total score at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and switch group
7)Intra-group comparison of changes in daily urination frequency at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
8)Intra-group comparison of changes in daytime urination frequency at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
9)Intra-group comparison of changes in nighttime urination frequency at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
10)Intra-group comparison of changes in daily urinary incontinence frequency at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
11)Intra-group comparison of changes in each OABSS score and total score at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group
12)Intra-group comparison of changes in each IPSS/QOL score and total score at 4, 8, and 12 weeks after the start of protocol treatment between the combination group and the switching group

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients aged 18 years or older at time of registration
2)Patients who have been diagnosed with overactive bladder (OAB) based on the Over Active Bladder Symptom Score (OABSS) (*) and who continue to have OAB symptoms (*) even after treatment with one of the following anticholinergic drugs for 4 weeks or more
* OABSS urinary urgency score of 2 points or more and OABSS total score of 3 points or more
-Propiverine hydrochloride 20mg (orally administered once a day after meals)
-Imidafenacin 0.1mg (administered twice a day, after breakfast and dinner)
-Solifenacin succinate 5mg (oral administration once a day)
-Fesoterodine fumarate 4mg (oral administration once a day)
-Oxybutynin hydrochloride transdermal preparation 73.5mg (applied once a day to either the lower leg, lower back, or thigh)
3)Patients who are willing and able to accurately fill out a urinary diary/questionnaire, including measuring urine volume for 3 days.
4)Patients who are willing and able to follow the study protocol, including study visits and tests.
5)Patients who have fully understood the content of this study and have given their written consent.

Exclude criteria

1)Patients with clinically significant bladder outlet obstruction
2)Patients with residual urine volume (> 150ml)
3)Patients with severe stress urinary incontinence or patients with mixed urinary incontinence
4)Patients with a continuously indwelling urinary catheter or patients who perform intermittent self-catheterization
5)Patients receiving non-drug treatment for urinary incontinence, including sacral nerve stimulation therapy. However, bladder training programs or pelvic floor muscle exercises that have been started within 30 days prior to registration is allowed.
6)Patients who are judged by the research physician to have a history of disease or surgery that may affect urinary evaluation due to OAB (such as patients who received botulinum toxin intravesical injection therapy)
7)Patients with chronic inflammatory disease or malignant disease (*) in the pelvis. *Patients who have undergone intravesical treatment for bladder malignancy within the past 12 months, or patients who have a history of bladder cancer, prostate cancer, or uterine cancer within 5 years before enrollment. However, patients with a history of bladder, prostate, or uterine cancer may be eligible for registration if they have undergone treatment, are cancer-free, and have not experienced recurrence for five years.
8)Patients with uncontrolled narrow-angle glaucoma, urinary retention or pyloric stenosis, severe ulcerative colitis, toxic megacolon, myasthenia gravis, or other patients for whom anticholinergic drugs are contraindicated by the principal investigator.
9)Patients with a history of hypersensitivity to the components of vibegron.
10)Patients who are or may be pregnant, or who are breastfeeding.
11)Patients who are deemed ineligible by the research physician for other medical, psychological, or other reasons.

Related Information

• Primary Sponsor: Yoshida Soichiro
• Source(s) of Monetary Support: KYORIN Pharmaceutical Co., Ltd.,KISSEI PHARMACEUTICAL CO., LTD.