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A decision aid for the treatment of Benign Prostatic Hyperplasia


- candidate number25282
- NTR NumberNTR6106
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-sep-2016
- Secondary IDsNW2014-21 METC Brabant
- Public TitleA decision aid for the treatment of Benign Prostatic Hyperplasia
- Scientific TitleA decision aid for the treatment of Benign Prostatic Hyperplasia: a prospective cohort study to investigate the effect
- ACRONYMBPH DA
- hypothesisPatients who have used the decision aid for making the treatment choice for benign prostatic hyperplasia: feel more informed, have more knowledge about the disease, feel more involved in making the decision, make a more value congruent choice, have less regret,
- Healt Condition(s) or Problem(s) studiedBenign prostatic hyperplasia
- Inclusion criteriaNew patient with a LUTS caused by benign prostatic hyperplasia who have the choice between:
- waiting OR start medication
- continue (other) medication OR operation
- Exclusion criteria-absolute operation indication (example: persistent urinary retention)
- speak not good enough dutch to understand the DA or questionnary
- cannot use a computer
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 12-sep-2016
- planned closingdate12-jul-2017
- Target number of participants200
- Interventionsusing a BPH decision aid
- Primary outcomevalue congruence and regret
- Secondary outcomedecisional conflict, SCIP-B, SDM-Q-9, EORTC-info-25, knowledge
- TimepointsT1: after using decision aid
T2: 3-6 months after treatment choice
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Fieke van der Wijden
- CONTACT for SCIENTIFIC QUERIES Fieke van der Wijden
- Sponsor/Initiator Elisabeth-Twee Steden ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Stichting Delectus
- Publications
- Brief summarya prospective cohort study to investigate the effect of a decision aid for benign prostatic hyperplasia compared to a historical control cohort.
- Main changes (audit trail)
- RECORD12-sep-2016 - 25-nov-2016


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