Comparative Effectiveness of Combined Low- and Standard-Dose Trospium and Solifenacin for Moderate Overactive Bladder Symptoms in Elderly Men and Women

Abstract

Objective: To increase the safety and effectiveness of treatments for overactive bladder (OAB) with moderate symptoms in elderly patients. Patients and Methods: Patients were examined at the Urodynamic Department of the Regional Diagnostic Center (Vladivostok, Russian Federation) from September 1, 2012 to December 31, 2012. The assignment of patients [n = 177, average age 69. 4 years, 98 women (55.4%) and 79 men (44.6%)] was random and blind in this placebo-controlled study. Patients were distributed into subgroups according to the method of treatment as follows: group А1: n = 57, trospium 30 mg/day + solifenacin 10 mg/day; group А2: n = 61, trospium 15 mg/day + solifenacin 5 mg/day; group А3: n = 59, placebo. All patients underwent a urodynamic examination in accordance with international standards before and 2 months after treatment. ICIQ-SF questionnaires recommended by the International Continence Society (ICS) and bladder diaries were used to evaluate the clinical results. The clinical severity of the OAB symptoms and the effectiveness of the treatment were evaluated based on the frequency of episodes of incontinence (EI) per day. Three or fewer EI per day were considered moderate dysfunction of the lower urinary tract. Results: Groups of elderly patients with moderate symptoms of OAB who were treated with standard- and low-dose trospium and solifenacin demonstrated a significant increase in the median values of reflex volume, bladder capacity, and detrusor compliance and a decrease in the frequency of urination and urinary urgencies. The frequency of EI in both of the main groups decreased by almost 2-fold in comparison to the initial data and reached the following values: group А1: 1.27 (-1.08), p ≤ 0.05; group A2: 1.49 (-1.18), p ≤ 0.05. The correlation with the decrease in the frequency of EI in these groups was r = 0.85 (p ≤ 0.01). The percentage of patients with a significant decrease (EI ≥1.0) among those treated with standard- and low-dose trospium and solifenacin increased synchronously, prompting us to suppose the absence of a direct correlation between medicine dose and therapeutic effect for moderate OAB symptoms. Conclusion: The combination of low-dose trospium and solifenacin provides good clinical and urodynamic effects in elderly patients with moderate symptoms of OAB. Combination of these drugs in standard doses for such patients is excessive.

Combination therapy in overactive bladder‐untapped research opportunities: A systematic review of the literature

“…Four articles were identified that examined the use of anticholinergic medications in combination with each other (Table ) . Three of the four studies were conducted by Kosilov et al at the Institute of Physical Health in Russia.…”

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality

“…Following a review of the abstracts, 491 citations were rejected for not meeting study inclusion criteria (ie, wrong study type, not OAB; no elderly patients, not β‐3 adrenergic agonists or muscarinic antagonists), 381 were excluded following full‐text review, and 18 were excluded during the data extraction phase for not meeting study inclusion criteria—17 of these included elderly patients but were post‐hoc analyses of elderly sub‐groups; one paper reported the open‐label extension phase of a trial. A total of eight RCT papers met all the study inclusion criteria and were included in the review …”

Treatment Outcome of Overactive Bladder Patients Receiving Antimuscarinic Therapy for More than One Year

“…Combined antimuscarinic agents were used in some of our patients. It has been reported that combined antimuscarinic agents could provide good clinical and urodynamic effects for elderly, refractory, neurogenic or even child OAB patients . However, while a β3‐adrenoceptor agonist is available, a combination of antimuscarinics and mirabegron may be a good alternative for refractory OAB patients to avoid additive adverse effects of combined antimuscarinic agents …”