The use of mono- and combination drug therapy in men and women with lower urinary tract symptoms (LUTS) in the UK: a retrospective observational study

Background Combination drug therapy for lower urinary tract symptoms (LUTS) is beneficial to selected patients and recommended by guidelines. Patterns of real-world LUTS drug use, especially combination drug therapy, have not been studied extensively. Moreover, further understanding of the recent landscape is required following the introduction of the beta-3-adrenoceptor agonist mirabegron in the UK in 2013 for overactive bladder (OAB). The objective was to describe mono- and combination drug therapy use for LUTS in patients in UK clinical practice. Methods This was a retrospective, descriptive, observational database study using UK Clinical Practice Research Datalink GOLD and linked databases. Men and women ≥ 18 years with a first prescription for any LUTS drug from 2014 to 2016 with ≥ 12 months continuous enrollment pre- and post-index date were included. Primary endpoints were mono- or combination drug therapy use for LUTS in male and female cohorts. Secondary endpoints were description of treatment prescribed, treatment persistence and patient demographics. Data were analyzed descriptively. Sub-cohorts were defined by drugs prescribed at index date. Results 79,472 patients (61.3% male) were included, based on index treatments. Of all men, 82.5% received any benign prostatic obstruction (BPO) drug, 25.4% any OAB drug, and 7.9% any BPO drug plus any OAB drug. As either mono- or combination drug therapy, 77.1% received an alpha-blocker, 18.9% a 5-alpha reductase inhibitor, 23.9% an antimuscarinic agent, and 2.1% mirabegron. Of all women, 94.5% received any OAB drug, 6.0% duloxetine, and 0.5% any OAB drug plus duloxetine. As either mono- or combination drug therapy, 87.7% received an antimuscarinic, and 9.7% mirabegron. In men or women receiving OAB treatment, approximately 2.5% received combination drug therapy with an antimuscarinic agent and mirabegron. For OAB drug monotherapies, mirabegron had the highest persistence in both male and female cohorts. Conclusions This study provides a better understanding of the recent landscape of LUTS drug use in UK clinical practice. It highlights potential undertreatment of storage symptoms in men with LUTS and the low use of combination OAB treatments.

Predictive Factors for Recurrence of Overactive Bladder after Discontinuation of an Antimuscarinic Agent

Background: Overactive bladder (OAB) is a common disease. However, the patients who stop taking medicines after clinical improvement are at risk for symptom recurrence. Objective: To determine the disease recurrence rates and evaluate the potential predictive factors for recurrent OAB symptoms after discontinuation of an antimuscarinic drug. Materials and Methods: The OAB patients who discontinued antimuscarinic drugs after symptom improvement were studied prospectively. The OAB symptoms were evaluated by the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaire. The symptom scores were evaluated at the time of recruitment and at 1, 3, 6, and 12 months after drug discontinuation. The curve of time to symptom recurrence was plotted. The factors associated with symptom recurrence were analyzed and compared. Results: Eighty-two patients including 40 (48.78%) males and 42 (51.22%) females, were included in the present study. Forty-one (50.0%) patients experienced recurrent symptoms within 12 months. The median time to symptom recurrence was 3.01 months (interquartile range [IQR] 1.0, 6.0). The mean symptom scores in the recurrent group at 1, 3, and 6 months were significantly higher than those in the non-recurrent group (10.75±7.39 versus 22.76±13.10, p<0.001; 10.89±8.93 versus 16.41±11.70, p=0.040; and 10.51±8.03 versus 22.33±14.59, p=0.001, respectively). The results of the univariate analyses indicated that other factors were not associated with recurrence. Conclusion: Symptom recurrence after antimuscarinic discontinuation is common in OAB patients. The high ICIQ-OAB score might be the predictive factor for recurrence. Most of the cases of symptom recurrence were observed within three months. Keywords: Muscarinic Antagonists, Overactive bladder, Predictive factors, Recurrence

The use of Mono- and Combination Pharmacotherapy in Men and Women with Lower Urinary Tract Symptoms (LUTS) in the UK: A Retrospective Observational Study

Background: Combination pharmacotherapy for lower urinary tract symptoms (LUTS) is beneficial to selected patients and recommended by guidelines. Patterns of real-world LUTS drug use, especially combination pharmacotherapy, have not been studied extensively. Moreover, further understanding of the recent landscape is required following the introduction of the beta-3-adrenoceptor agonist mirabegron in the UK in 2013 for overactive bladder (OAB). The objective was to describe mono- and combination pharmacotherapy use for LUTS in patients in UK clinical practice. Methods: This was a retrospective, descriptive, observational database study using UK Clinical Practice Research Datalink GOLD and linked databases. Men and women ≥ 18 years with a first prescription for any LUTS drug from 2014–2016 with ≥ 12 months continuous enrolment pre- and post-index date were included. Primary endpoints were mono- or combination pharmacotherapy use for LUTS in male and female cohorts. Secondary endpoints were description of treatment prescribed, treatment persistence and patient demographics. Data were analyzed descriptively. Sub-cohorts were defined by drugs prescribed at index date.Results: 79,472 patients (61.3% male) were included, based on index treatments. Of all men, 82.5% received any benign prostatic obstruction (BPO) drug, 25.4% any OAB drug, and 7.9% any BPO drug plus any OAB drug. As either mono- or combination pharmacotherapy, 77.1% received an alpha-blocker, 18.9% a 5-alpha reductase inhibitor, 23.9% an antimuscarinic agent, and 2.1% mirabegron. Of all women, 94.5% received any OAB drug, 6.0% duloxetine, and 0.5% any OAB drug plus duloxetine. As either mono- or combination pharmacotherapy, 87.7% received an antimuscarinic, and 9.7% mirabegron. In men or women receiving OAB treatment, approximately 2.5% received combination pharmacotherapy with an antimuscarinic agent and mirabegron. For OAB drug monopharmacotherapies, mirabegron had the highest persistence in both male and female cohorts. Conclusions: This study provides a better understanding of the recent landscape of LUTS drug use in UK clinical practice. It highlights potential undertreatment of storage symptoms in men and the low use of combination OAB treatments.

A Comparative Observational Study to Evaluate the Efficacy of Mid-Urethral Sling with Botulinum Toxin A Injection in Urinary Incontinence Patients

This study aimed to evaluate and compare the efficacy and safety of mid-urethral sling (MUS) with botulinum toxin A (BoNT-A) versus MUS only in women with mixed urinary incontinence. This was a comparative observational study, and total of 73 patients were enrolled. A total of 38 and 35 patients received MUS only and MUS with BoNT-A injection, respectively. The efficacy outcome included change in Urinary Incontinence Outcome Scores (UIOS), change in Overactive Bladder Symptom Score (OABSS), and use of antimuscarinic agent or beta-3 agonist. Safety assessments included adverse events including urinary retention, increased postvoid residual volumes, and urinary tract infection. MUS with BoNT-A injection was insignificantly better than MUS only in urinary incontinence outcome (88% vs. 71%, respectively, p = 0.085) at week three. Among the 33 patients with detrusor overactivity (DO), patients who received BoNT-A had a higher cure rate of incontinence (88% vs. 41%, p = 0.01) and less required antimuscarinic agent or beta-3 agonist (31% vs. 94%, p < 0.001) compared to patients who did not receive BoNT-A injection. There was no significant difference in the incidences of adverse events between two groups. BoNT-A injection with MUS demonstrated efficacy and safety in the treatment of mixed urinary incontinence, specifically for women with DO.