📃 Paper Title: Tolterodine Treatment Improves Storage Symptoms Suggestive of Overactive Bladder in Men Treated With a-Blockers (ADAM study)
🧍 Author: Christopher Chapple
🕒 Year: 2009
📚 Journal: European Urology
🌎 Country: United Kingdom
ㅤContext to the study:
What benefits does use of tolterodine have in overactive bladder?
ㅤ✅ Take-home message of study:
Bothersome overactive bladder symptoms like frequency and urgency improve in men treated with tolterodine extended release (ER) for 12 weeks despite continued α-blocker therapy.
ㅤ Double-blind randomized controlled trial: tolterodine ER 4 mg per day vs placebo for 12 weeks in men taking α-blocker therapy.
ㅤ
Study participants:
Inclusion criteria: men aged ≥40 years with frequency, urgency, and at least moderate problems reported on the Patient Perception of Bladder Condition (PPBC), despite being on a stable dose of α-blocker for ≥1 month.
Exclusion criteria: postvoid residual volume ≥200 mL, history of acute urinary retention requiring catheterisation, poor detrusor function or presumed clinically significant bladder outlet obstruction, prostatic surgery, history of prostate cancer or prostate-specific antigen level >10 ng/ml, urinary tract infection (UTI) or recurrent UTI, neurologic disease or injury, or treatment with an anticholinergic ≤30 days before screening.
ㅤ
ㅤ
Key study outcomes:
323 and 329 patients were randomized to either placebo and α-blocker or tolterodine ER and α-blocker therapy.
Primary endpoint: Percentage of subjects reporting improvement from baseline on the PPBC (≥1 point) at week 12. Improvement was reported by 63.6% men on tolterodine and 61.6% on placebo (p=0.7)
Efficacy of treatment was evaluated also with following means:
Bladder diaries: tolterodine ER resulted in significantly greater reductions in the majority of bladder diary end points (reduction in urgency, nocturia and pollakyuria)
IPSS: tolterodine ER resulted in improvements of the IPSS storage subscale (-2.6 vs -2.1, p=0.04)
Overactive bladder questionnaire: tolterodine ER resulted in improvement in scores for the symptom bother scale (-17.9 vs -14.4, p=0.009) and coping domain (15.4 vs 12.4, p=0.049)
ㅤ
ㅤ
Study Limitations:
Data only on short term efficacy (3 months) of tolterodine; no real nontreatment group, as both groups received α-blockers on top of tolterodine or placebo; bladder diaries may have lead to behavioural modifications due to increased awareness of symptoms in both treatment groups, possibly diluting the difference between the treatment groups. Type of α-blocker was not standardized. Prostate size was unknown so whether treatment response was influenced by prostate size cannot be measured. Trial duration limited to 12 weeks.
ㅤ