Benign Prostatic Hyperplasia Clinical Trial
Official title:
Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice
Ageing and the availability of medication has led to an increase of elderly male patients
being treated for lower urinary tract symptoms (LUTS), or voiding problems ("prostate
problems"). However, guidelines are vague as to which patients should and which should not
be treated, and how.
Although several treatment modalities have proven efficacy in selected populations, it is
unclear how effective these treatments are in daily practice.
This study investigates the hypothesis that a treatment protocol in which clear indications
are formulated for all treatment modalities is more effective, as compared to current usual
primary care, in reducing both symptoms as related to the quality of voiding in elderly
males.
Guidelines fail to provide specific diagnostic criteria and clear indications for therapy in
elderly male patients with lower urinary tract symptoms. Consequently, the group of patients
diagnosed with LUTS in primary care is very heterogeneous, and daily care varies widely.
Consequently, efficacy trials of alpha-blockers, 5-alpha-reductase inhibitors and surgery
performed in selected, well defined homogeneous populations cannot easily be generalised to
the heterogeneous primary care situation.
A practical randomised trial enrolling patients on the basis of symptoms have the advantage
of being of immediate practical value.
We compare a treatment protocol with clear indications for therapy with current usual care
in a population selected on symptoms rather than well defined diseases or definite test
results.
Two hundred eight subjects were randomised into intervention (N=104) and control (N=104)
conditions.
After two years of follow-up, IPSS scores, bother scores, maximum urinary flow rates and the
incidence of acute urinary retention and urinary tract infections have been compared.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04807296 -
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
|
N/A | |
| Recruiting |
NCT05574244 -
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
|
N/A | |
| Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
| Not yet recruiting |
NCT04245566 -
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
|
Phase 3 | |
| Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
| Completed |
NCT03246880 -
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
|
Phase 3 | |
| Completed |
NCT02509975 -
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
|
N/A | |
| Completed |
NCT02283684 -
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
|
Phase 4 | |
| Completed |
NCT02206243 -
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
|
||
| Completed |
NCT01454349 -
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 1/Phase 2 | |
| Completed |
NCT01438775 -
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
| Completed |
NCT01152190 -
A Study in Benign Prostatic Hyperplasia
|
Phase 3 | |
| Completed |
NCT01139762 -
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
|
Phase 3 | |
| Active, not recruiting |
NCT00400894 -
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
|
N/A | |
| Completed |
NCT00224133 -
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
|
Phase 3 | |
| Completed |
NCT00701779 -
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
|
Phase 4 | |
| Unknown status |
NCT00381108 -
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
|
Phase 1 | |
| Terminated |
NCT02962674 -
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
|
N/A | |
| Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
| Recruiting |
NCT04853914 -
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
|
N/A |