Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with Solifenacin/Tamsulosin.

NCT06528613 | Recruiting

• 1 other identifier: Elpen Pharmaceutical Co. Inc.
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 6

Brief Summary

Benign prostatic hyperplasia (BPH) is an age-related progressive condition of the prostate gland that results in an increase in prostate size. Although the "normal" prostate in adult men usually has a volume of 15-30 ml, a value above 30 ml is usually considered "enlarged". However, the threshold at which a prostate is considered enlarged has not been strictly defined and therefore for many physicians an enlarged prostate is a subjective finding on examination. BPH can only be defined histologically (increase in the number of epithelial cells and stromal cells), but in clinical practice it is characterized by lower urinary tract symptoms \[LUTS\]. The disease leads to increased pressure in the urethra, causing resistance to urine flow, known as Bladder Outlet Obstruction (BOO). This resistance can also lead to changes in bladder function caused by the obstruction, such as overactivity of the bladder detrusor muscle or, conversely, reduced detrusor contractility. BOO can present as LUTS, infections or retention, as well as other conditions. LUTS can be divided into storage (irritant), obstructive (urinary) and post-urinary symptoms and appear frequently causing intense discomfort, reducing the quality of life. LUTS are traditionally associated with bladder outlet resistance (BOO), most commonly when histologic BPH progresses through benign prostatic enlargement (BPE) to benign prostatic obstruction (BPO).The European Urological Association (EAU) reports that LUTS are a common problem in adult men with a significant impact on quality of life (QoL). Accordingly, he suggests the use of the a1-blocker/muscarinic receptor antagonist combination in men with moderate to severe storage symptoms, voiding symptoms and PVR \< 150 ml, in order to reduce the risk of acute urinary retention and relieve irritants. (storage) symptoms, leading to an improvement in the patient's quality of life. Given the small abundance of data for patients in Greece with BPH, this study will evaluate the fixed combination of solifenacin/tamsulosin in terms of disease control and improvement of the quality of life of patients with BPH. Before enrolling in the study and before signing the consent form, patients must have already received the drug with solifenacin/tamsulosin and then they are enrolled in the observational study where the physician applies his/her standard clinical practice.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• The assessment of disease control (BPH) and quality of life of patients.

  The change in the total score (questions 1-7) and the quality-of-life question score of the International Prostate Symptom Score (IPSS) questionnaire after six months of treatment with a fixed combination of solifenacin/tamsulosin. The total disease control score is calculated by summing the scores of the seven symptom-related questions. In particular : Questions 1-6: 6-point response scale from 0 (not at all) to 5 (almost always). Question 7: 6-point response scale from 0 (none) to 5 (5 or more). This gives an overall score ranging from 0 to 35 where : 0-7: mildly symptomatic, 8-19: moderately symptomatic, 20-35: severely symptomatic. Concerning the quality-of-life question score : 7-point response scale from 0 (no impact on QOL) to 6 (high impact on QOL).

  6 months

Secondary Outcomes (2)

• The assessment of patients' overall impression of their condition from Benign Prostatic Hyperplasia (BPH).

  6 months

• Assessment of the safety of the solifenacin/tamsulosin fixed dose combination during the study.

  6 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Biological male adult patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male adult patients with moderate to severe symptoms of BPH received monotherapy and did not respond adequately and are receiving FDC of Solifenacin/Tamsulosin.

You may qualify if:

• Male adult patient with moderate to severe symptoms of BPH receiving monotherapy and not responding adequately.
• Male adult patient with BPH who has fully understood the study procedures and signed an informed consent form.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (6)

Second Department of Urology, Sismanoglio Hospital, Athens, Greece.

Athens, Greece, 15126, Greece

NOT YET RECRUITING

Department of Urology, Venizelio General Ηospital

Heraklion, Greece, 71409, Greece

RECRUITING

Department of Urology, General Hospital of Messinia

Kalamata, Greece, 24100, Greece

RECRUITING

Department of Urology, General Hospital of Larissa

Larissa, Greece, 41221, Greece

RECRUITING

Department of Urology, University Hospital of Rion

Pátrai, Greece, 26504, Greece

RECRUITING

First Department of Urology, School of Medicine, Aristotle University of Thessaloniki

Thessaloniki, Greece, 54635, Greece

RECRUITING

Related Publications (6)

• Shibata K, Hirasawa A, Moriyama N, Kawabe K, Ogawa S, Tsujimoto G. Alpha 1a-adrenoceptor polymorphism: pharmacological characterization and association with benign prostatic hypertrophy. Br J Pharmacol. 1996 Jul;118(6):1403-8. doi: 10.1111/j.1476-5381.1996.tb15552.x.

  PMID: 8832064 BACKGROUND

• Lepor H. Pathophysiology of benign prostatic hyperplasia in the aging male population. Rev Urol. 2005;7 Suppl 4(Suppl 4):S3-S12.

  PMID: 16986052 BACKGROUND

• Ekman P. The prostate as an endocrine organ: androgens and estrogens. Prostate Suppl. 2000;10:14-8. No abstract available.

  PMID: 11056488 BACKGROUND

• GBD 2019 Benign Prostatic Hyperplasia Collaborators. The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from 2000 to 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2022 Nov;3(11):e754-e776. doi: 10.1016/S2666-7568(22)00213-6. Epub 2022 Oct 20.

  PMID: 36273485 BACKGROUND

• Johnson TV, Abbasi A, Ehrlich SS, Kleris RS, Owen-Smith A, Raison CL, Master VA. IPSS quality of life question: a possible indicator of depression among patients with lower urinary tract symptoms. Can J Urol. 2012 Feb;19(1):6100-4.

  PMID: 22316511 BACKGROUND

• Viktrup L, Hayes RP, Wang P, Shen W. Construct validation of patient global impression of severity (PGI-S) and improvement (PGI-I) questionnaires in the treatment of men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. BMC Urol. 2012 Nov 7;12:30. doi: 10.1186/1471-2490-12-30.

  PMID: 23134716 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexandros Ginis

  Elpen Pharmaceutical Co. Inc.

  STUDY DIRECTOR

Central Study Contacts

Polyanthi Papanastasiou

CONTACT

+302111865777; p.papanastasiou@elpen.gr

Alexandros Ginis

CONTACT

+302111865734; aginis@elpen.gr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 30, 2024
• Study Start: October 23, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (6)