No registrations found.
Source
Brief title
Health condition
Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Proportion of patients with symptom persistence (defined as IPSS ¡Ã8 points) at Month 24 in each country.
Secondary outcome
Secondary Endpoints to be evaluated in each country:
1. Proportion of patients with symptom persistence (defined as IPSS ¡Ã8 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 ¡Ã3 points, and, separately, IPSS increase of ¡Ã4 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 ¡Ã3 points, and, separately, IPSS reduction of ¡Ã4 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 visit¢Ó, 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.
Background summary
This is a registry conducted within a sample of European Union (EU) general practitioner (GP) outpatient clinics and urologist¡¯s 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.
Study objective
This is a registry conducted within a sample of European Union (EU) general practitioner (GP) outpatient clinics and urologist¡¯s 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.
Study design
1. FPI planned: DEC 2009;
2. LPI planned: DEC 2010;
3. LPO planned:DEC 2012.
Intervention
No intervention. Observational.
Inclusion criteria
A patient will be considered eligible for inclusion in this registry only if all of the following criteria apply:
1. Males, aged ¡Ã50 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 ¡Ã8 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 ¡Ã 1 month;
- 5ARIs either as monotherapy or in combination for ¡Ã 6 months;
- Other LUTS/BPH medical therapy for ¡Ã1 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 ¡Ã 1 month;
b. 5ARIs either as monotherapy or in combination for ¡Ã 6 months;
c. Other LUTS/BPH medical therapy for ¡Ã1 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 criteria
A 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1897 |
NTR-old | NTR2013 |
Other | : N/A |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |