Vesicare (solifenacin) / Astellas - LARVOL DELTA

Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Mackay Memorial Hospital | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date

Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Mackay Memorial Hospital | N=100 ➔ 200 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder (clinicaltrials.gov) - P4 | N=300 | Recruiting | Sponsor: Mackay Memorial Hospital | Trial completion date: Jun 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Overactive Bladder

Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms (clinicaltrials.gov) - P=N/A | N=64 | Completed | Sponsor: Ain Shams University

New trial

Real-time Assessment of Cardiac Function in the Management of Calcium Channel Blocker Toxicity (ATS 2025) - "A 19-year-old female with a history of major depressive disorder presented with somnolence and hyperglycemia 3 hours after ingesting 57 tablets of amlodipine (10mg), 5 tablets of hydroxyzine (25mg), and 25 tablets of solifenacin (10mg). VA-ECMO likewise provides robust circulatory support though is not without inherent risks. Our experience in this case supports contemporaneous use of real-time assessment of cardiac function to mitigate risk and optimize management of severe CCB toxicity."

CNS Disorders • Depression • Diabetes • Major Depressive Disorder • Mood Disorders • Psychiatry

Effectiveness of simultaneous electroacupuncture stimulation on the tibial and ilioinguinal-iliohypogastric nerves in the treatment of refractory overactive bladder syndrome in women. (PubMed, Curr Urol) - "All patients in both groups had received anticholinergic muscarinic receptor antagonists (tolterodine/solifenacin), β3 receptor agonists, flupentixol/melitracen, and other basic treatment regimens with poor results. This therapy is safe, convenient, and free of significant adverse reactions, providing a new approach for the clinical treatment of refractory OAB in these patients. It significantly improves bladder symptoms and alleviates anxiety and depression, thereby markedly enhancing the patients' quality of life."

Journal • CNS Disorders • Depression • Mood Disorders • Overactive Bladder • Psychiatry • Urology

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: University of Arkansas | Active, not recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

Pharmacological treatment of pediatric nocturnal enuresis: a systematic review and network meta-analysis. (PubMed, Pediatr Nephrol) - "Combination therapy may be superior to monotherapy in NE management. The most frequently used combination therapy is desmopressin plus anticholinergic agents. All drugs seemed to be safe."

Journal • Retrospective data • Review • Pediatrics • Urinary Incontinence

Assessment of efficacy of mirabegron, solifenacin, tadalafil 5 mg and combination therapy in female patients with overactive bladder: a double blinded multicenter prospective placebo-controlled trial. (PubMed, Minerva Urol Nephrol) - "The novel combination therapies of tadalafil 5mg with solifenacin or mirabegron are more effective in reducing OAB symptoms and improving urodynamic parameters compared to single-agent therapies and placebo. These findings suggest that combination therapy is alternative pathway which can enhance outcomes for female patients with OAB. Further research is warranted to validate these results and explore long-term efficacy and safety."

Journal • Overactive Bladder

Efficacy and Safety of VDS+SU in the Treatment of OAB-dry in Children (clinicaltrials.gov) - P=N/A | N=180 | Recruiting | Sponsor: Xing Liu | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2026 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Enrollment open • Trial completion date • Trial primary completion date • Overactive Bladder • Pediatrics

Pharmacotherapy for overactive bladder syndrome and the risk of incident dementia. (PubMed, World J Urol) - "Most anticholinergic medications and mirabegron are associated with an increased risk of dementia compared to untreated controls with OAB, while fesoterodine was not found to be associated with an increased risk in any group."

Clinical • Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Dementia • Overactive Bladder

Protective effects of alpha-lipoic acid on memory deficit induced by repeated doses of solifenacin in mice: the role of nitro-oxidative stress. (PubMed, Metab Brain Dis) - "Taken together, our data suggest that ALA can be administered as an adjunctive drug in patients requiring prolonged use of Sol to mitigate these adverse central nervous system effects. However, clinical studies need to be performed to corroborate preclinical research."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Urology

Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms (clinicaltrials.gov) - P3 | N=189 | Not yet recruiting | Sponsor: Bir Hospital | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date

Efficacy and safety of Solifenacin combined with Mirabegron in treating overactive bladder in female patients following bladder instillation for bladder cancer. (PubMed, Am J Transl Res) - "The combination of Mirabegron and Solifenacin offers superior therapeutic effects in female patients with OAB following bladder instillation for bladder cancer, significantly improving patients' quality of life without adverse effects."

Journal • Genito-urinary Cancer • Oncology • Overactive Bladder • Solid Tumor • Urology

Long-term efficacy of Mirabegron-anticholinergic combination in paediatric neurogenic bladder. (PubMed, J Pediatr Urol) - "MAC combination effectively manages paediatric neurogenic bladder resistant to AC and BTX therapy. The VUD benefits (present in 77.8 %) and symptom benefits (present in 61 %) are maintained and ongoing for a significant period (median 33 and 43 months respectively) when commenced before significant loss of compliance. MAC presents a promising long-term treatment option for the paediatric neurogenic bladder."

Journal • Retrospective data • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Oncology • Orthopedics • Pediatrics

KALLIRROI: Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with Solifenacin/Tamsulosin. (clinicaltrials.gov) - P=N/A | N=450 | Recruiting | Sponsor: Elpen Pharmaceutical Co. Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Benign Prostatic Hyperplasia

Deprescribing DRrugs for Overactive Bladder in General Practice (DROP) (clinicaltrials.gov) - P=N/A | N=72 | Recruiting | Sponsor: Anne Estrup Olesen | Trial primary completion date: Dec 2024 ➔ Dec 2025 | Enrolling by invitation ➔ Recruiting

Enrollment status • Trial primary completion date • Overactive Bladder

Comparisons of urinary bladder responses to common antimuscarinics reveals unique effects of darifenacin. (PubMed, Front Physiol) - "Carbachol concentration-response curves were performed on paired tissues in the absence or presence of commonly prescribed antimuscarinics: darifenacin, fesoterodine, oxybutynin, solifenacin, trospium, and tolterodine. Darifenacin reduced the maximum contraction in adult U&LP preparations to carbachol by 49% and to αβ-methylene-ATP by 35%. Darifenacin presents as an antimuscarinic medication that influences non-muscarinic pathways in urinary bladder tissue, indicating its potential to assist OAB patients with non-muscarinic pathophysiology."

Journal • Overactive Bladder

Efficacy and safety of solifenacin for overactive bladder: An updated systematic review and meta-analysis. (PubMed, Urol Ann) - "Solifenacin had a significant number of AEs compared to placebo (MD = 1.75, 95% CI: 1.25-2.45, P = 0.001). Solifenacin significantly decreased urgency episode, incontinence episodes, micturition frequency, and nocturia episode, and had a higher urine volume per 24 h. There was a significant number of AEs in patients receiving solifenacin."

Journal • Retrospective data • Review • Overactive Bladder

Bladder drugs and risk of dementia: Danish nationwide active comparator study. (PubMed, BMJ Med) - "Conditional logistic regression provided incidence rate ratios for associations between anticholinergic bladder drugs and dementia compared with non-use and mirabegron use adjusted for educational level, cardiovascular disease, diabetes, hypertension, dyslipidaemia, and Charlson Comorbidity Index...Compared with non-use, all types of anticholinergic bladder drugs were associated with increased incidence rate ratios for dementia: tolterodine 1.43 (95% CI 1.38 to 1.49), solifenacin 1.37 (1.29 to 1.46), trospium 1.52 (1.37 to 1.67), and fesoterodine 1.48 (1.26 to 1.74)...These findings highlight the relevance of using an active comparator. Future research should evaluate the risk of cognitive impairment and dementia for both types of bladder drugs."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • Urinary Incontinence • Urology

Evaluation of Small-Molecule Candidates as Modulators of M-Type K+ Currents: Impacts on Current Amplitude, Gating, and Voltage-Dependent Hysteresis. (PubMed, Int J Mol Sci) - "The inhibitors of IK(M) highlighted here include bisoprolol, brivaracetam, cannabidiol, nalbuphine, phenobarbital, and remdesivir. Conversely, compounds such as flupirtine, kynurenic acid, naringenin, QO-58, and solifenacin have been shown to enhance IK(M). These modulators show potential as pharmacological or therapeutic strategies for treating certain disorders linked to gain-of-function or loss-of-function mutations in M-type K+ (KV7x or KCNQx) channels."

Journal • Review

The Beneficial Effects of Alpha-Blockers, Antimuscarinics, Beta 3-Agonist, and PDE5-Inhibitors for Ureteral Stent-Related Discomfort: A Systematic Review and Meta-Analysis from KSER Update Series. (PubMed, Medicina (Kaunas)) - "This study utilized a network meta-analysis to evaluate stent-related discomfort (SRD) in patients with alpha-blockers (alfuzosin, tamsulosin, and silodosin), antimuscarinics (solifenacin), beta 3-agonists (mirabegron), and phosphodiesterase 5-inhibitors (tadalafil) versus a placebo. Compared with the placebo, solifenacin, tamsulosin, and alfuzosin significantly decreased the USS. In our study, solifenacin may be considered the most effective medication for SRD."

Clinical • Journal • Retrospective data • Review • Renal Calculi • Urolithiasis • Urology

Efficacy and safety of sacral nerve root magnetic stimulation combined with solifenacin in female patients with overactive bladder. (PubMed, Am J Transl Res) - "The combination therapy of SNRMS and solifenacin demonstrated significant improvements over solifenacin monotherapy in reducing OAB symptoms in female patients, providing a higher QoL without increasing bothersome adverse effects."

Journal • Overactive Bladder

Efficacy and Safety of Mirabegron Compared to Solifenacin in Treatment of Non-neurogenic Overactive Bladder in Children: A Randomized Controlled Trial. (PubMed, Int Braz J Urol) - "Mirabegron is more effective with fewer adverse effects than solifenacin for treatment of children with OAB. Mirabegron treatment improves daytime symptoms and nocturnal enuresis with less risk of constipation. It may be considered as first-line pharmacotherapy in this patient population."

Clinical • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Overactive Bladder • Urinary Incontinence

Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms (clinicaltrials.gov) - P3 | N=189 | Not yet recruiting | Sponsor: Bir Hospital

New P3 trial