Solifenacin for Benign Prostatic Hyperplasia (BPH)
Solifenacin should not be used as monotherapy for BPH but can be effectively used as combination therapy with alpha-blockers in men who have both BPH and storage symptoms of overactive bladder. 1
Mechanism and Role in BPH Management
- Solifenacin is an antimuscarinic agent that targets storage symptoms (urgency, frequency, nocturia) rather than voiding symptoms that are the primary manifestation of BPH 1
- When used alone, antimuscarinic medications like solifenacin and tolterodine have minimal effect on BPH symptoms and rank low in effectiveness compared to alpha-blockers and 5-alpha reductase inhibitors 1
- The 2023 European Association of Urology guidelines recognize solifenacin as effective for treating storage symptoms in patients with lower urinary tract symptoms, but not as primary BPH therapy 1, 2
Combination Therapy Approach
- Solifenacin is most effective when combined with alpha-blockers (particularly tamsulosin) for men with both storage and voiding symptoms 1, 2
- The NEPTUNE trial demonstrated that combination therapy with solifenacin and tamsulosin in a single tablet showed significant efficacy for lower urinary tract symptoms in men with BPH 1, 3
- Combination therapy with tamsulosin and solifenacin has been shown to improve storage symptoms significantly more than tamsulosin alone 4, 5
Safety Considerations
- The primary concern with antimuscarinic use in BPH patients is the theoretical risk of urinary retention 1
- However, clinical studies show that solifenacin plus tamsulosin combination was not associated with significant increases in urinary retention in men with BPH and bladder outlet obstruction 6
- The NEPTUNE/NEPTUNE II studies demonstrated that incidence of urinary retention during treatment with solifenacin+tamsulosin combinations for up to 1 year was low in men with both storage and voiding symptoms 1
Dosing and Administration
- The standard dose of solifenacin when used in combination therapy is 5-6 mg daily 7, 6
- Combination therapy should be initiated in patients who have both voiding symptoms (weak stream, hesitancy) and bothersome storage symptoms (urgency, frequency) 1, 4
- Earlier treatment with combination therapy has been shown to improve storage symptoms and quality-of-life scores more quickly than sequential therapy (alpha-blocker followed by adding antimuscarinic) 5
Monitoring and Follow-up
- Patients should be monitored for post-void residual volume increases, especially in the first few weeks of treatment 1, 6
- If urinary retention or significant increases in post-void residual volume occur, the antimuscarinic component may need to be discontinued 1
- Treatment efficacy should be assessed using validated symptom scores such as IPSS (International Prostate Symptom Score) and OABSS (Overactive Bladder Symptom Score) 7, 4
Alternative Approaches
- For men with BPH and storage symptoms, mirabegron (a β3-adrenoceptor agonist) is an alternative to antimuscarinics and may have a lower risk of urinary retention 1
- Alpha-blockers remain the first-line therapy for BPH with predominantly voiding symptoms 1
- 5-alpha reductase inhibitors should be considered for men with larger prostates (>30cc) or PSA >1.5ng/mL 1