Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02244320

Enrollment

4150

Registered

2014-09-19

Start date

2002-09-30

Completion date

Unknown

Last updated

2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Brief summary

The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))

Interventions

DRUGTamsulosin

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Patients suffering from BPH symptoms * Preceding treatment with a phytotherapeutic for at least 4 weeks * IPSS sum score ≥ 8 points prior to treatment start with ALNA® * Indication for a switch to treatment with ALNA® for a minimum period of 2 months

Exclusion criteria

* Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency * Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study

Design outcomes

Primary

Measure	Time frame
Change in IPSS sum score	Day 1, 2 months
Change in Quality-of-Life Index (QoL) rated on a 7-point scale	Day 1, 2 months

Secondary

Measure	Time frame
Change in residual urine volume (ml)	Day 1, 2 months
Patient's global assessment of the preceding phytotherapy on a 3-point scale	Day 1
Patient's global assessment of the therapy with ALNA® on a 3-point scale	after 2 months
Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale	Day 1
Change in sexual satisfaction rated on a 4-point scale	Day 1, 2 months
Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale	Day 1
Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale	after 2 months
Number of patients with adverse drug reactions (ADR)	up to 2 months
Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale	after 2 months
Change in maximum urinary flow rate (ml/sec)	Day 1, 2 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026