Plain English Summary
Background and study aims
An overactive bladder is where a person regularly gets a sudden and compelling need or desire to pass urine. Many people suffer from overactive bladder. Most of these patients are treated first with anticholinergic drugs. Many of these patients are not taking these drugs after one year. The aim of this study is to find out whether patients continue to use the anticholinergic solifenacin after one year and the reason when they stop.
Who can participate?
Patients aged over 18 with overactive bladder who have been prescribed solifenacin
What does the study involve?
Participants receive the same medication as they normally would, and are contacted by telephone at 1, 3, 6 and 12 months after starting solifenacin. They are asked whether they are still taking the medication, about possible side effects, and if they have stopped taking the medication, what are their reasons for stopping.
What are the possible benefits and risk of participating?
Participants receive feedback about their use of solifenacin, and the information could be used to improve the future use of the medication. There are no risks involved.
Where is the study run from?
Erasmus Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
June 2009 to July 2013
Who is funding the study?
Erasmus Medical Center (Netherlands)
Who is the main contact?
Dr Bertil Blok
Trial website
Contact information
Type
Scientific
Primary contact
Dr Bertil Blok
ORCID ID
http://orcid.org/0000-0001-9354-7395
Contact details
's-Gravendijkwal 230
Room Ba-204
Rotterdam
3015 CE
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC-2009-094
Study information
Scientific title
Real life persistence rate with antimuscarinic treatment in patients with idiopathic or neurogenic overactive bladder: a prospective cohort study with solifenacin
Acronym
Study hypothesis
To investigate the persistence rate in real life among patients with idiopathic or neurogenic overactive bladder (OAB) who were prescribed solifenacin.
Ethics approval
Erasmus Medical Center Ethics Committee, 09/04/2009, ref: MEC-2009-094
Study design
Prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. A paper version of the patient information sheet is available in Dutch upon request. Please use the contact details below
Condition
Overactive bladder
Intervention
After giving informed consent, patients older than 18 years and newly prescribed solifenacin because of complaints of idiopathic or neurogenic OAB, were included. Patients who had used anticholinergic drugs less than 7 days before they started solifenacin were excluded. The starting dose was chosen by the doctor who prescribed the solifenacin but could be adjusted during the study period. Participants were allowed to continue possible other urologic medications, for example alfa-blockers, but not other anticholinergic drugs. Telephone surveys were taken at 1, 3, 6 and 12 months after starting solifenacin. The patients were asked whether they were continuing the medication. They were also interviewed about possible side effects and if they had discontinued the therapy, what had been reasons for stopping.
Intervention type
Drug
Phase
Not Applicable
Drug names
Solifenacin
Primary outcome measure
Persistence of usage, measured by telephone surveys at 1, 3, 6 and 12 months
Secondary outcome measures
Reasons for stopping medication, measured by telephone surveys at 1, 3, 6 and 12 months
Overall trial start date
01/06/2009
Overall trial end date
01/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients older than 18 years
2. Idiopathic or neurogenic overactive bladder
3. Newly prescribed solifenacin
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
123
Participant exclusion criteria
1. Patients not on solifenacin
2. Patients who had used anticholinergic drugs less than 7 days before they started solifenacin
Recruitment start date
01/06/2009
Recruitment end date
01/07/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 CE
Netherlands
Sponsor information
Organisation
Erasmus Medical Center
Sponsor details
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)107 040 704
research@erasmusmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medisch Centrum
Alternative name(s)
Erasmus Medical Center, Erasmus MC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
The study has been submitted for publication
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Marloes Tijnagel (mtijn@hotmail.com)
Intention to publish date
01/07/2017
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN13129226_BasicResults_16Mar17
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28403849
Publication citations
Additional files
- ISRCTN13129226_BasicResults_16Mar17.docx Uploaded 20/03/2017