PMID- 36205739
OWN - NLM
STAT- MEDLINE
DCOM- 20221101
LR  - 20230130
IS  - 1433-8726 (Electronic)
IS  - 0724-4983 (Print)
IS  - 0724-4983 (Linking)
VI  - 40
IP  - 11
DP  - 2022 Nov
TI  - Efficacy of TAC-302 for patients with detrusor underactivity and overactive 
      bladder: a randomized, double-blind, placebo-controlled phase 2 study.
PG  - 2799-2805
LID - 10.1007/s00345-022-04163-4 [doi]
AB  - PURPOSE: This multicenter, randomized, double-blind, placebo-controlled phase 2 
      study evaluated the efficacy and safety of TAC-302, a novel drug that restores 
      neurite outgrowth, in patients with detrusor underactivity (DU) and overactive 
      bladder (OAB). METHODS: After 2-4 weeks of observation, patients were randomized 
      2:1 to receive oral TAC-302 200 mg or placebo twice daily for 12 weeks. The 
      primary endpoint was detrusor contraction strength, estimated by bladder 
      contractility index (BCI) for males and projected isovolumetric pressure 1 (PIP1) 
      for females. Secondary endpoints included changes in bladder voiding efficiency 
      (BVE) and safety. RESULTS: Seventy-six patients were included (TAC-302, n = 52; 
      placebo, n = 24). The mean (standard deviation [SD]) BCI for males was 64.6 
      (16.6) at baseline and 75.2 (21.1) at week 12 (p < 0.001) with TAC-302 (n = 27), 
      and 61.3 (16.6) and 60.5 (16.7) (p = 0.82) with placebo (n = 11). The respective 
      mean (SD) PIP1 for females was 18.8 (6.6) and 29.4 (9.4) (p < 0.001) with TAC-302 
      (n = 15), and 20.6 (7.5) and 25.5 (9.6) (p = 0.14) with placebo (n = 7). TAC-302 
      significantly increased BCI in males and BVE in both sexes. TAC-302 efficacy on 
      OAB was not clearly shown. The incidences of adverse events (AEs), serious AEs, 
      and AEs leading to dose interruption were similar between groups; no adverse drug 
      reactions occurred. CONCLUSION: Considering the significant effects on BCI in 
      males and BVE in both sexes, TAC-302 may benefit patients with DU. REGISTRATION: 
      ClinicalTrials.gov Identifier NCT03175029 registered 6/5/2017.
CI  - (c) 2022. The Author(s).
FAU - Yoshida, Masaki
AU  - Yoshida M
AUID- ORCID: 0000-0002-9057-2277
AD  - Department of Urology, Sakurajyuji Hospital, Kumamoto, Japan.
AD  - National Center for Geriatrics and Gerontology, Aichi, Japan.
FAU - Gotoh, Momokazu
AU  - Gotoh M
AD  - Japan Community Health Care Organization Chukyo Hospital, Aichi, Japan.
FAU - Yokoyama, Osamu
AU  - Yokoyama O
AD  - Department of Urology, Harue Hospital, Fukui, Japan.
AD  - Department of Urology, University of Fukui, Fukui, Japan.
FAU - Kakizaki, Hidehiro
AU  - Kakizaki H
AD  - Department of Renal and Urologic Surgery, Asahikawa Medical University, Hokkaido, 
      Japan.
FAU - Yamanishi, Tomonori
AU  - Yamanishi T
AD  - Department of Urology, Continence Center, Dokkyo Medical University, Tochigi, 
      Japan.
FAU - Yamaguchi, Osamu
AU  - Yamaguchi O
AD  - Fukushima Medical University, 1 Hikarigaoka, Fukushima-shi, Fukushima, 960-1295, 
      Japan. oyamagu52@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT03175029
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20221007
PL  - Germany
TA  - World J Urol
JT  - World journal of urology
JID - 8307716
RN  - 0 (tac-302)
SB  - IM
MH  - Male
MH  - Female
MH  - Humans
MH  - *Urinary Bladder, Overactive/drug therapy/complications
MH  - *Urinary Bladder, Underactive/complications
MH  - Urodynamics
MH  - Urination
MH  - Double-Blind Method
MH  - Treatment Outcome
PMC - PMC9617838
OTO - NOTNLM
OT  - Bladder voiding efficiency
OT  - Detrusor underactivity
OT  - Overactive bladder
OT  - TAC-302
OT  - Underactive bladder
COIS- M. Yoshida has received consultancy fees from Taiho Pharmaceutical Co., Ltd. and 
      speaker fees from KYORIN Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., 
      Ltd., Astellas Pharma Inc., Ferring Pharmaceuticals Co., Ltd., and Pfizer Inc. M. 
      Gotoh has received consultancy fees from Taiho Pharmaceutical Co., Ltd., Lilium 
      Otsuka Co., Ltd., and speaker fees from Astellas Pharma Inc., Kissei 
      Pharmaceutical Co., Ltd., KYORIN Pharmaceutical Co., Ltd., Ferring 
      Pharmaceuticals Co., Ltd., and Glaxo Smith Kline Plc. O. Yokoyama has received 
      consultancy fees from Taiho Pharmaceutical Co., Ltd., Glaxo Smith Kline Plc., and 
      Astellas Pharma Inc. and speaker fees from Glaxo Smith Kline Plc., Astellas 
      Pharma Inc., and Kissei Pharmaceutical Co., Ltd. H. Kakizaki has received 
      consultancy fees from Taiho Pharmaceutical Co., Ltd., and Astellas Pharma Inc., 
      and speaker fees from Astellas Pharma Inc., Kissei Pharmaceutical Co., Ltd., 
      Pfizer Inc., KYORIN Pharmaceutical Co., Ltd., and Ferring Pharmaceuticals Co., 
      Ltd. T. Yamanishi has received consultancy fees from Taiho Pharmaceutical Co., 
      Ltd., KYORIN Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Pfizer 
      Inc., Astellas Pharma Inc., Takeda Pharmaceutical Co., Ltd., Daiichi Sankyo Co., 
      Ltd., Nippon Shinyaku Co., Ltd., Nihon Kohden Corp., and Coloplast Corp. O. 
      Yamaguchi has received consultancy fees from Astellas Pharma Inc., Taiho 
      Pharmaceutical Co., Ltd., and Ferring Pharmaceuticals Co., Ltd., and speaker fees 
      from Astellas Pharma Inc.
EDAT- 2022/10/08 06:00
MHDA- 2022/11/02 06:00
PMCR- 2022/10/07
CRDT- 2022/10/07 11:05
PHST- 2022/04/05 00:00 [received]
PHST- 2022/09/21 00:00 [accepted]
PHST- 2022/10/08 06:00 [pubmed]
PHST- 2022/11/02 06:00 [medline]
PHST- 2022/10/07 11:05 [entrez]
PHST- 2022/10/07 00:00 [pmc-release]
AID - 10.1007/s00345-022-04163-4 [pii]
AID - 4163 [pii]
AID - 10.1007/s00345-022-04163-4 [doi]
PST - ppublish
SO  - World J Urol. 2022 Nov;40(11):2799-2805. doi: 10.1007/s00345-022-04163-4. Epub 
      2022 Oct 7.