Evaluation of the IncoStress device for urinary incontinence: a feasibility study and pilot randomised controlled trial.
Acceptability
Effectiveness
Female
Pilot project
Treatment outcome
Vagina
Journal
International urogynecology journal
ISSN: 1433-3023
Titre abrégé: Int Urogynecol J
Pays: England
ID NLM: 101567041
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
30
04
2018
accepted:
01
08
2018
pubmed:
15
8
2018
medline:
9
4
2020
entrez:
15
8
2018
Statut:
ppublish
Résumé
The aim of this study was to assess the feasibility of recruitment to and outcomes from a pilot randomised study of the IncoStress device as an adjunct to conservative treatment for urinary incontinence. Women with urinary incontinence were randomised on a 2:1 basis to usual care (control) or usual care plus use of the IncoStress device (intervention). Process outcomes (retention and compliance) were recorded plus symptom outcomes (IQOL and ICIQ-FLUTS questionnaires). A sample of participants took part in an interview to understand the frequency of use of the device and satisfaction. Eighty women (51 intervention, 29 control) were recruited. Follow-up responses were obtained from 34 intervention group (66.7%) and 17 (58.6%) control patients. Women used the device for a median 3 days a week (0-7), 18 out of 34 (53%) found it easy to use and 21 (61.8%) were satisfied with the device. Median IQOL score in the intervention group improved from a baseline of 42.4 (0-94) to 68.2 (5-98) at follow-up and in the control group from 45.5 (0-88) to 53.0 (0-94). Median ICIQ-FLUTS score in the intervention group improved from 14.5 (6-35) to 12.5 (4-26) and in the control group from 15.0 (5-35) to 14.0 (6-38). Recruitment and randomisation were feasible and robust. This study demonstrates that a large-scale RCT is feasible and the IncoStress has potential value.
Identifiants
pubmed: 30105441
doi: 10.1007/s00192-018-3749-5
pii: 10.1007/s00192-018-3749-5
pmc: PMC6647229
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1365-1369Subventions
Organisme : University of South Wales
ID : 20000
Pays : International
Références
Cochrane Database Syst Rev. 2014 Dec 17;(12):CD001756
pubmed: 25517397
Int Urogynecol J. 2012 Dec;23(12):1727-34
pubmed: 22588140
Lancet. 1977 Dec 3;2(8049):1161
pubmed: 73066
Urology. 1996 Jan;47(1):67-71; discussion 71-2
pubmed: 8560665
Urology. 2016 Jan;87:70-5
pubmed: 26375847
BJU Int. 2004 Jun;93(9):1246-52
pubmed: 15180616
Obstet Gynecol. 2010 Mar;115(3):609-17
pubmed: 20177294
BMJ. 2013 Sep 10;347:f5170
pubmed: 24021756
Int Urogynecol J Pelvic Floor Dysfunct. 2004 Sep-Oct;15(5):302-7
pubmed: 15300365
BJU Int. 2001 Dec;88(9):889-92
pubmed: 11851609
Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):118-21
pubmed: 22453323
Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001756
pubmed: 16625547
Int J Womens Health. 2018 Apr 17;10:195-201
pubmed: 29713205
Am J Obstet Gynecol. 2004 Apr;190(4):1025-9
pubmed: 15118635
Neurourol Urodyn. 2004;23(4):322-30
pubmed: 15227649
Obstet Gynecol. 2008 Feb;111(2 Pt 1):324-31
pubmed: 18238969
Int J Fertil Womens Med. 2005 Jan-Feb;50(1):24-9
pubmed: 15971718