PMID- 33772330
OWN - NLM
STAT- MEDLINE
DCOM- 20211028
LR  - 20240402
IS  - 1432-0711 (Electronic)
IS  - 0932-0067 (Print)
IS  - 0932-0067 (Linking)
VI  - 304
IP  - 2
DP  - 2021 Aug
TI  - Vaginal treatment with lactic acid gel delays relapses in recurrent urinary tract 
      infections: results from an open, multicentre observational study.
PG  - 409-417
LID - 10.1007/s00404-021-06040-8 [doi]
AB  - PURPOSE: The main objective of this open, prospective, multicentre, observational 
      study is to investigate the relapse rate and tolerability of lactic acid gels in 
      adult female patients with recurrent urinary tract infections during routine 
      practice. METHODS: Data were collected from patients undergoing intermittent 
      short courses of intravaginal treatment with lactic acid gel for prevention of 
      recurrent urinary tract infections. The observation period for individual 
      patients was 4 months, aimed at covering four short courses of intravaginal 
      treatment. Data on UTI relapses, tolerability, handling and satisfaction with the 
      treatment were collected via patient diaries and physician assessments and 
      comprised any adverse events (AEs). RESULTS: In total, 72 patients were treated. 
      During the last 12 months prior to the study, patients had on average 4.0 UTIs. 
      In the 4 months after commencing treatment, 63.5% of patients had no recurrence 
      of UTI symptoms. Overall efficacy was rated by physicians as 'excellent/good' for 
      96.7% of patients. The patients' overall acceptance of local treatment was high 
      with 94.1% being '(very) satisfied'. Similarly, handling was rated as '(very) 
      easy' by 94.2% of patients. The tolerability was assessed as 'highly 
      tolerable/tolerable' by over 98% of patients and physicians alike. Safety 
      analyses reported six AEs of mild intensity, all of which had resolved by the end 
      of the study. CONCLUSION: Treatment with lactic acid gel may increase resilience 
      against uropathogens, possibly preventing the need for antibiotic prevention of 
      recurrent urinary tract infections. Treatment was positively assessed by the 
      patients. The physician assessments corroborate these findings. TRIAL 
      REGISTRATION NUMBER AND DATE OF REGISTRATION: DRKS00016760, 18.02.2019.
CI  - (c) 2021. The Author(s).
FAU - Diebold, Ruth
AU  - Diebold R
AUID- ORCID: 0000-0002-2007-6040
AD  - Dr. Kade Pharmazeutische Fabrik GmbH, Berlin, Germany. ruth.diebold@kade.de.
FAU - Schopf, Bettina
AU  - Schopf B
AD  - Pharmalog Institut fur klinische Forschung GmbH, Ismaning, Germany.
FAU - Stammer, Holger
AU  - Stammer H
AD  - Pharmalog Institut fur klinische Forschung GmbH, Ismaning, Germany.
FAU - Mendling, Werner
AU  - Mendling W
AD  - German Centre for Infections in Obstetrics and Gynecology, Wuppertal, Germany.
LA  - eng
SI  - DRKS/DRKS00016760
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210327
PL  - Germany
TA  - Arch Gynecol Obstet
JT  - Archives of gynecology and obstetrics
JID - 8710213
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Gels)
RN  - 33X04XA5AT (Lactic Acid)
SB  - IM
EIN - Arch Gynecol Obstet. 2021 May 15;:. PMID: 33991244
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Bacterial Agents/administration & dosage/*therapeutic use
MH  - Female
MH  - Gels/administration & dosage/*therapeutic use
MH  - Humans
MH  - Lactic Acid/administration & dosage/*therapeutic use
MH  - Middle Aged
MH  - Prospective Studies
MH  - Recurrence
MH  - Secondary Prevention
MH  - Urinary Tract Infections/drug therapy/*prevention & control
MH  - Young Adult
PMC - PMC8277613
OTO - NOTNLM
OT  - Lactic acid gel
OT  - Preventive treatment
OT  - Relapse reduction
OT  - Urinary tract infection
OT  - Uropathogen
COIS- Author R Diebold is an employee of DR. KADE Pharmazeutische Fabrik GmbH, Berlin, 
      Germany and received support in form of salary. The authors B Schopf and H 
      Stammer are employees of the Clinical Research Organistation Pharmalog Institut 
      fur klinische Forschung GmbH, which was contracted by DR. KADE. The scientific 
      study coordinator W Mendling received honorarium for this work as well as speaker 
      honoraria at scientific training events organized by the funder.
EDAT- 2021/03/28 06:00
MHDA- 2021/10/29 06:00
PMCR- 2021/03/27
CRDT- 2021/03/27 06:24
PHST- 2020/11/24 00:00 [received]
PHST- 2021/03/17 00:00 [accepted]
PHST- 2021/03/28 06:00 [pubmed]
PHST- 2021/10/29 06:00 [medline]
PHST- 2021/03/27 06:24 [entrez]
PHST- 2021/03/27 00:00 [pmc-release]
AID - 10.1007/s00404-021-06040-8 [pii]
AID - 6040 [pii]
AID - 10.1007/s00404-021-06040-8 [doi]
PST - ppublish
SO  - Arch Gynecol Obstet. 2021 Aug;304(2):409-417. doi: 10.1007/s00404-021-06040-8. 
      Epub 2021 Mar 27.