Introduction
Though Beta3-agonist is a known option for overactive bladder (OAB), many patients still experience lower urinary tract symptoms (LUTS), mainly storage symptoms, with only symptomatic relief. This study evaluates whether combination therapy outperforms the standard approach.
Materials and Methods
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It was a randomized, open-label prospective single study that included patients who had LUTS due to OAB and were aged between 18-80 years. Patients with infravesical obstruction, bladder stones, post-void residual urine (PVR)>200 ml, and urinary tract infections were excluded from the study. Patients were divided into 2 groups:
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Group 1 (experimental)- Patients were administered Vesusten 5 mg i.m. 3 times a week in total 10 doses + Mirabegron 50 mg daily.
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Group 2 (control)- Patients were administered Mirabegron only.
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Patients were asked to maintain bladder diaries and fill OAB-q (Overactive Bladder Questionnaire) and PPBC (Patient Perception of Bladder Condition) questionnaires. Bladder wall thickness was measured using transrectal ultrasound for men or transvaginal ultrasound when the bladder reached a volume of 50 ml.
Results
100 patients (11 males and 89 females) having a mean age of 51 years were enrolled in the study. Out of 100 patients 95 patients (46 from the group 1 and 49 from the group 2) completed follow-up.
The following table shows the results comparing different outcomes amongst the 2 groups:
|
Parameter |
Group 1 |
Group 2 |
p-value |
|
|
|
|
|
|
OAB-q score change (Primary Endpoint) |
-2.73 |
-0.91 |
<0.01 |
|
PPBC score change |
-1.72 |
-0.37 |
<0.01 |
|
Urination rate change per 72 hours |
-3.9 |
-1.1 |
<0.01 |
|
Increase in volume per urination (mL) |
13.3 |
5.6 |
<0.001 |
|
PVR (Post-Void Residual) change (mL) |
-7.4 |
1.3 |
0.02 |
|
Bladder wall thickness change |
No change |
No change |
— |
|
Adverse Events (AE) |
35 mild cases (pain/discomfort at injection site, resolved within days, no additional treatment) |
None |
— |
Conclusion
The combination therapy of Vesusten and beta-3 agonist allowed significant symptom improvement in patients with LUTS due to OAB. The therapy had no effect on bladder wall thickness and mild AEs were noted which did not require any additional treatment interventions.
European Association of Urology, 21-24 March 2025, Madrid, Spain
