Condition category
Urological and Genital Diseases
Date applied
03/03/2017
Date assigned
17/03/2017
Last edited
18/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Results - basic reporting

See additional file ISRCTN13129226_BasicResults_16Mar17

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28403849

Publication citations

Additional files

Editorial Notes

18/04/2017: Publication reference added. 20/03/2017: The basic results of this trial have been uploaded as an additional file.