Clinical Trials Logo
  1. Home
  2. Prostatic Hyperplasia
  3. NCT02244307
  4. Details
NCT02244307 Clinical Trial

Observational Study in Patients Suffering From Benign Prostatic Hyperplasia Treated With Alpha-adrenergic Blockade

Prostatic Hyperplasia Clinical Trial

Official title:
Evolution of Patients Suffering From Benign Prostatic Hyperplasia (BPH) Treated With Alpha-adrenergic Blockade (JOSEPHINE)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02244307
Other study ID # 527.28
Secondary ID
Status Completed
Phase N/A
First received September 18, 2014
Last updated September 18, 2014
Start date January 2000

Study information
Verified date September 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: Conseil National de l'Ordre des Médecins
Study type Observational

Clinical Trial Summary

The primary objective of this observational study was the assessment of prognosis factors for having recourse to prostatic surgery in patients with BPH who were administered class-1 alpha blockers. The secondary objectives were the assessment of the time from alpha-adrenergic blockade treatment initiation to surgery and the evolution of patients during the study.

Recruitment information / eligibility
Status Completed
Enrollment 4561
Est. completion date
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Any patient with BPH for whom alpha-blocker treatment is indicated

- Patients who are already on class-1 alpha-blockers can only participate in the study if all information required is known and/or available

Exclusion Criteria:

- Patient's follow-up not possible

- Patients participating in another study

- History of BPH surgery

- Prostate cancer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• alpha-adrenergic blocker

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of prognosis factors for having recourse to prostatic surgery up to 2 years No
Secondary Time form alpha-adrenergic blockade treatment initiation to surgery up to 2 years No
Secondary Occurrence of concomitant BPH diseases up to 2 years No
Secondary Total International Prostate Symptom Score (IPSS) up to 2 years No
Secondary Percentage of patients with ongoing BPH treatment up to 2 years No
See also
  Status Clinical Trial Phase
Completed NCT02578953 - Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects Phase 1
Terminated NCT02396420 - Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams Phase 2
Terminated NCT04398966 - Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia N/A
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT02947958 - Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia N/A
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT00427882 - Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study Phase 4
Completed NCT02244320 - Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin) N/A
Completed NCT01254071 - A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. Phase 1
Recruiting NCT04108871 - Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men N/A
Recruiting NCT05686525 - Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH N/A
Completed NCT01957189 - This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples Phase 1
Completed NCT00316732 - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS N/A
Completed NCT02715401 - PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers Phase 1
Recruiting NCT02278679 - Digital Rectal Exam Proficiency Tool N/A
Completed NCT01482676 - The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction N/A
Completed NCT01376258 - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database N/A
Completed NCT00822952 - Prostate Mechanical Imager (PMI) Clinical Bridging Study N/A
Completed NCT00527605 - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Terminated NCT00563654 - Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A

External Links