Persistence rate with medical treatment in patients with idiopathic or neurogenic overactive bladder
| ISRCTN | ISRCTN13129226 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13129226 |
| Secondary identifying numbers | MEC-2009-094 |
- Submission date
- 03/03/2017
- Registration date
- 17/03/2017
- Last edited
- 18/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
's-Gravendijkwal 230
Room Ba-204
Rotterdam
3015 CE
Netherlands
 ORCID ID |
0000-0001-9354-7395 |
|---|
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant 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 |
| Scientific title | Real life persistence rate with antimuscarinic treatment in patients with idiopathic or neurogenic overactive bladder: a prospective cohort study with solifenacin |
| Study objectives | To investigate the persistence rate in real life among patients with idiopathic or neurogenic overactive bladder (OAB) who were prescribed solifenacin. |
| Ethics approval(s) | Erasmus Medical Center Ethics Committee, 09/04/2009, ref: MEC-2009-094 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2009 |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 123 |
| Key inclusion criteria | 1. Patients older than 18 years 2. Idiopathic or neurogenic overactive bladder 3. Newly prescribed solifenacin |
| Key exclusion criteria | 1. Patients not on solifenacin 2. Patients who had used anticholinergic drugs less than 7 days before they started solifenacin |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3015 CE
Netherlands
Sponsor information
Hospital/treatment centre
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
| Phone | +31 (0)107 040 704 |
|---|---|
| research@erasmusmc.nl | |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/07/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/03/2017 | 20/03/2017 | No | No | |
| Results article | results | 13/04/2017 | Yes | No |
Additional files
- ISRCTN13129226_BasicResults_16Mar17.docx
- Uploaded 20/03/2017
Editorial Notes
18/04/2017: Publication reference added.
20/03/2017: The basic results of this trial have been uploaded as an additional file.
