Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment.
OBJECTIVE
To evaluate the efficacy and safety of gabapentin in comparison to solifenacin succinate and placebo for the treatment of adult patients with overactive bladder (OAB).


METHODS
A 12-week, randomized, double-blind, double dummy placebo-controlled, clinical trial was conducted between October 2010 and August 2014 at a tertiary medical center. Eligible and consenting patients included were randomized into three treatment groups (placebo, gabapentin and solifenacin). After a 12-week treatment period, an intention to treat analysis was applied to assess between group differences on the micturitions and urgency episodes per 24 h; which were evaluated by 3-day micturition diary mean change from baseline to post treatment. Health related quality of life (HRQOL) domains were likewise assessed by OAB questionnaire (OAB-q). Adverse event were monitored and summarized. Study results were analyzed at statistical significance of 0.05. (ClinicalTrials.gov ID NCT01486706) RESULT: A total of 94 participants were included for end-study efficacy and safety analysis. Compared to placebo, gabapentin and solifenacin have statistically significant improvement in mean number of micturitions per 24 h (adjusted mean difference [AMD] -1.179, 95%CI -1.98, -0.38; P < 0.001; -1.706, 95%CI -2.52, -0.09; P < 0.001; respectively), and in mean number of urgency episodes per 24 h (AMD -0.903, 95%CI -1.44, -0.37; P < 0.001; -0.896, 95%CI -1.44, -0.35; P < 0.001). Gabapentin also demonstrated significant improvement over the solifenacin in the mean number of nocturia episodes/24 h (AMD -0.607, 95%CI -1.04, -0.18; P < 0.001). Adverse event related to gabapentin treatment was lesser than solifenacin, and comparable to placebo.


CONCLUSIONS
Gabapentin treatment with acceptable safety profile, improves OAB symptoms and HRQOL domains.
Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines.|Department of Preventive and Community Medicine, St. Luke's College of Medicine, Quezon City, Philippines.
Michael E
ME
Chua
Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines.|Department of Surgery, Delos Santos-STI Medical Center, Quezon City, Philippines.
Manuel C
MC
See
Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines.|Comprehensive Pelvic Floor Center, St. Luke's Medical Center, Quezon City, Philippines.
Ednalyn B
EB
Esmeňa
Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines.|Department of Urology, East Avenue Medical Center, Quezon City, Philippines.
Jaime C
JC
Balingit
Institute of Urology, St. Luke's Medical Center, Quezon City, Philippines.|Department of Urology, National Kidney and Transplant Institute, Quezon City, Philippines.
Marcelino L
ML
Morales
D000293:Adolescent; D000328:Adult; D000368:Aged; D000588:Amines / Q000008:administration & dosage* / Q000009:adverse effects; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000077206:Gabapentin; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D000069464:Solifenacin Succinate / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D064804:Urological Agents / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage* / Q000009:adverse effects
D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D018727:Muscarinic Antagonists; D064804:Urological Agents; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin; D000069464:Solifenacin Succinate
gabapentin; overactive bladder; randomized controlled trial; solifenacin