Comparing sustained release Tamsulosin tablet (Protral Opas) and Tamsulosin (Protral) capsule on retrograde ejaculation side effect

Evaluating sustained release Tamsulosin tablet (Protral Opas) retrograde ejaculation side effect in comparison to Tamsulosin capsule (Protral) in treatment of patients with benign prostatic hyperplasia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200112046093N1

Enrollment

120

Registered

2020-05-04

Start date

2020-03-12

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Benign prostatic hyperplasia. Enlarged prostate

Interventions

Intervention 1: Intervention group: The group receiving Tamsulosin 0.4 mg sustained release (Protral Opas_Tasnim Pharmaceutical) Tablet Daily for Three Months. Intervention 2: Control group:The group

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Individuals who have been already diagnosed as benign prostatic hyperplasia patients and have been treated by Tamsulosin They have sexually active behaviors They have formal consent to participate in the study

Exclusion criteria

Exclusion criteria: Patient with history of pelvic and perineal surgery or pelvic and perineal region manipulation by reason of probable neuronal dameges of this region.

Design outcomes

Primary

Measure	Time frame
Retrograde ejaculation. Timepoint: The beginning of the study (before the intervention) and 3 months after the start of the intervention. Method of measurement: Asking from patient.	—

Secondary

Measure	Time frame
Orthostatic hypotension. Timepoint: The beginning of the study (before the intervention) and 3 months after the start of the intervention. Method of measurement: Sphygmomanometer.;Headache. Timepoint: The beginning of the study (before the intervention) and 3 months after the start of the intervention. Method of measurement: Asking from patient.;Blurred vision. Timepoint: The beginning of the study (before the intervention) and 3 months after the start of the intervention. Method of measurement: Asking from patient.	—

Measure

Time frame

Orthostatic hypotension. Timepoint: The beginning of the study (before the intervention) and 3 months after the start of the intervention. Method of measurement: Sphygmomanometer.;Headache. Timepoint: The beginning of the study (before the intervention) and 3 months after the start of the intervention. Method of measurement: Asking from patient.;Blurred vision. Timepoint: The beginning of the study (before the intervention) and 3 months after the start of the intervention. Method of measurement: Asking from patient.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Farshad Namdari

Artesh University of Medical Sciences

farshad.namd@yahoo.com+98 21 6604 3575

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026