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European registry evaluating management practices and pharmacological treatment outcomes in patients with LUTS/BPH. °įEuropean LUTS/BPH Registry°Ī.


- candidate number6481
- NTR NumberNTR2013
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-sep-2009
- Secondary IDsN/A 
- Public TitleEuropean registry evaluating management practices and pharmacological treatment outcomes in patients with LUTS/BPH. °įEuropean LUTS/BPH Registry°Ī.
- Scientific TitleEuropean Registry Evaluating Management Practices of General Practitioners and Urologists and Pharmacological Treatment Outcomes in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.
- ACRONYMEVOLUTION REGISTRY
- hypothesisThis is a registry conducted within a sample of European Union (EU) general practitioner (GP) outpatient clinics and urologist°Įs hospital or office based clinics. The registry aims to collect real-life data across the different countries on:
1. The usual management of Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia (LUTS/BPH);
2. The effect of LUTS/BPH and its pharmacological treatment outcomes on LUTS/BPH-related health status, general quality of life (QoL), and sexual function.
- Healt Condition(s) or Problem(s) studiedBenign prostatic hyperplasia, Lower urinary tract symptoms
- Inclusion criteriaA patient will be considered eligible for inclusion in this registry only if all of the following criteria apply:
1. Males, aged °√50 years;
2. Patients with LUTS/BPH presenting to the GP or urologist who are either:
A. Presently/recently untreated with pharmacological agents for LUTS/BPH and with an IPSS °√8 starting LUTS/BPH pharmacological treatment at or directly after the baseline visit, and fulfilling one of the following criteria:
a. Newly diagnosed;
b. Previously managed with watchful waiting;
c. Discontinued LUTS/BPH pharmacological treatment prior to the baseline visit for the following period:
- Blockers or phytotherapy or anticholinergics for °√ 1 month;
- 5ARIs either as monotherapy or in combination for °√ 6 months;
- Other LUTS/BPH medical therapy for °√1 months;
OR
B. Presently/recently treated with pharmacological agents for LUTS/BPH prior to the baseline visit for the following period, and will continue LUTS/BPH pharmacological treatment:
a. Blockers or phytotherapy or anticholinergics for °√ 1 month;
b. 5ARIs either as monotherapy or in combination for °√ 6 months;
c. Other LUTS/BPH medical therapy for °√1 months.
3. Patient has given written informed consent to take part in the registry for a period up to 2 years;
4. Patient is capable of understanding and completing the questionnaires.
- Exclusion criteriaA patient will not be eligible for inclusion in this registry if any of the following criteria apply:
1. Patients with other pathological or metabolic conditions that might explain the LUTS (e.g. bladder infection, chronic cystitis, bladder/prostate cancer, bladder stones);
2. Patients in whom the decision has been taken at baseline visit to manage them with watchful waiting or other then pharmacological LUTS/BPH therapy;
3. Patients with previous history of prostate cancer;
4. Patients who are participating, or have participated in the last 6 months, in any interventional clinical trial;
5. Patients planning to move to another part of the country or abroad which indicates that they need to discontinue participation prior to the total follow up of 2 years;
6. Patients previously treated with minimal invasive or surgical treatments for their LUTS/BPH or surgical treatments involving the bladder, prostate or urethra;
7. Patients with a history or current illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the registry.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 26-mei-2009
- planned closingdate24-jun-2013
- Target number of participants2000
- InterventionsNo intervention. Observational.
- Primary outcomeProportion of patients with symptom persistence (defined as IPSS °√8 points) at Month 24 in each country.
- Secondary outcomeSecondary Endpoints to be evaluated in each country:
1. Proportion of patients with symptom persistence (defined as IPSS °√8 points) at baseline visit** and at Month 6*, and at Month 12, and changes from baseline visit** to Month 12 and to Month 24;
2. Proportion of patients with symptom worsening (defined as IPSS increase of °√3 points, and, separately, IPSS increase of °√4 points from baseline visit) at Month 6*, and at Month 12 and at Month 24;
3. Proportion of patients with symptom improvement (defined as IPSS reduction of °√3 points, and, separately, IPSS reduction of °√4 points from baseline visit) at Month 6*, and at Month 12 and at Month 24;
4. IPSS at baseline visit, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24;
5. Proportion of patients waking up >3 times per night at baseline visit, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24;
6. Proportion of patients with mild (IPSS=1-7), and moderate (IPSS=8-19), and severe (IPSS=20-35) symptoms at baseline visitĘ”, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24;
7. IPSS Q8 at baseline visit, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24;
8. BPH Impact Index (BII) at baseline visit, and at Month 6*, and at Month 12, and at Month 24.
- Timepoints1. FPI planned: DEC 2009;
2. LPI planned: DEC 2010;
3. LPO planned:DEC 2012.
- Trial web sitehttp://www.uroweb.org/research/projects/
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. Christien Caris
- CONTACT for SCIENTIFIC QUERIESMD, PhD Wim Witjes
- Sponsor/Initiator European Association of Urology
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryThis is a registry conducted within a sample of European Union (EU) general practitioner (GP) outpatient clinics and urologist°Įs hospital or office based clinics. The registry aims to collect real-life data across the different countries on i) the usual management of Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia (LUTS/BPH), ii) the effect of LUTS/BPH and its pharmacological treatment outcomes on LUTS/BPH-related health status, general quality of life (QoL), and sexual function.
- Main changes (audit trail)
- RECORD15-sep-2009 - 7-okt-2017


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