PMID- 34184772
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20211125
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 40
IP  - 6
DP  - 2021 Aug
TI  - A randomized, placebo-controlled clinical development program exploring the use 
      of litoxetine for treating urinary incontinence.
PG  - 1515-1523
LID - 10.1002/nau.24690 [doi]
AB  - AIMS: To investigate the safety and efficacy of litoxetine, a serotonin reuptake 
      inhibitor, in treating urinary incontinence (UI) and mixed urinary incontinence 
      (MUI). METHODS: Two randomized, double-blind, placebo-controlled clinical trials 
      (RCT1 and RCT2) were conducted. RCT1, which included 196 women aged 18-75 with 
      MUI randomized 1:1:1:1 to receive 10, 20, or 40 mg litoxetine or placebo orally 
      twice daily (BID) for 12 weeks, investigated the efficacy (including changes in 
      patient reported outcomes) and safety of litoxetine compared to placebo. RCT2, 
      which included 82 men and women aged 18-70 with any UI type randomly assigned 2:1 
      to receive 30 mg litoxetine or placebo orally BID for 8 weeks including a 2 week 
      dose titration period, investigated the safety (including psychiatric safety) and 
      efficacy of litoxetine compared to placebo. Efficacy was measured as the change 
      in number of incontinence episodes per week and assessed using an analysis of 
      covariance with missing data imputed by Predictive Mean Matching. Safety was 
      assessed by adverse events (AEs) and physical examinations and analyzed using 
      descriptive statistics. RESULTS: The 30-mg and placebo groups in RCT2 showed no 
      difference in frequency of AEs, and litoxetine reduced the number of incontinence 
      episodes per week compared to placebo. Although RCT1 suffered an unexpectedly 
      high placebo response, and therefore did not meet the primary efficacy endpoint, 
      71% of participants receiving 40 mg litoxetine reported a clinically meaningful 
      improvement in the King's Health Questionnaire. CONCLUSIONS: Litoxetine may be a 
      safe, effective and well-tolerated treatment for patients with UI.
CI  - (c) 2021 Wiley Periodicals LLC.
FAU - Dmochowski, Roger R
AU  - Dmochowski RR
AD  - Department of Urology, Vanderbilt University, Nashville, Tennessee, USA.
FAU - Haab, Francois
AU  - Haab F
AD  - Urologie Paris-Opera, Paris, France.
FAU - Robinson, Dudley
AU  - Robinson D
AUID- ORCID: 0000-0002-4879-6672
AD  - Department of Urogynaecology, Kings College Hospital, London, UK.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210629
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
RN  - 0 (Piperidines)
RN  - 9980ST005G (litoxetine)
SB  - IM
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Piperidines
MH  - Treatment Outcome
MH  - *Urinary Incontinence
MH  - Urinary Incontinence, Urge
OTO - NOTNLM
OT  - litoxetine
OT  - mixed urinary incontinence
OT  - randomized controlled trial
OT  - urinary incontinence
EDAT- 2021/06/30 06:00
MHDA- 2021/11/26 06:00
CRDT- 2021/06/29 09:25
PHST- 2021/03/22 00:00 [revised]
PHST- 2020/11/06 00:00 [received]
PHST- 2021/04/07 00:00 [accepted]
PHST- 2021/06/30 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2021/06/29 09:25 [entrez]
AID - 10.1002/nau.24690 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2021 Aug;40(6):1515-1523. doi: 10.1002/nau.24690. Epub 2021 Jun 
      29.