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Comparison of the Effects of Alternate-Day Tadalafil and Tamsulosin Use with Daily Tamsulosin Use on Lower Urinary Tract Symptoms and Sexual Dysfunction in Men with Benign Prostatic Hyperplasia

Protocol summary

Study aim
To compare the effectiveness of alternating daily tadalafil 5 mg plus tamsulosin 0.4 mg versus daily tamsulosin 0.4 mg in improving lower urinary tract symptoms and sexual dysfunction in men with symptomatic benign prostatic hyperplasia (BPH).
Design
A randomized, parallel-group, controlled clinical trial with two study arms. A total of 62 participants will be randomly allocated (1:1) using block randomization with a block size of four.
Settings and conduct
The study will be conducted among men with symptomatic benign prostatic hyperplasia referred to the Urology Clinic of Modares Hospital, Tehran. 62 eligible participants will be randomly allocated to two intervention groups. One group will receive daily tamsulosin, while the other will receive alternating daily tadalafil and tamsulosin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men aged ≥50 years with symptomatic benign prostatic hyperplasia (BPH), IPSS >10, prostate volume >20 mL, able to complete the 12-week follow-up, and providing written informed consent. Criteria for non-entry: Suspected or confirmed prostate cancer, previous prostate or lower urinary tract surgery, significant urinary tract disorders, severe renal or hepatic impairment, recent myocardial infarction or stroke, unstable cardiovascular disease or uncontrolled diabetes, current use of nitrates or medications contraindicated with tadalafil, and known contraindications or hypersensitivity to tamsulosin or tadalafil.
Intervention groups
Intervention group 1: Participants will receive tamsulosin 0.4 mg once daily for 12 weeks. Intervention group 2: Participants will receive an alternating regimen of tadalafil 5 mg and tamsulosin 0.4 mg on alternate days for 12 weeks, such that one medication (either tadalafil or tamsulosin) is taken each day.
Main outcome variables
ower urinary tract symptoms (LUTS) Sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251121068066N14
Registration date: 2026-08-15, 1405/05/24
Registration timing: prospective

Last update: 2026-08-15, 1405/05/24
Update count: 0
Registration date
2026-08-15, 1405/05/24
Registrant information
Name
Atiyeh Hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 718 4680
Email address
articlelab2025ir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-09-11, 1405/06/20
Expected recruitment end date
2026-11-06, 1405/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Alternate-Day Tadalafil and Tamsulosin Use with Daily Tamsulosin Use on Lower Urinary Tract Symptoms and Sexual Dysfunction in Men with Benign Prostatic Hyperplasia
Public title
Evaluation of the Effect of Alternating Tadalafil and Tamsulosin Compared with Tamsulosin Alone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men aged ≥50 years. Clinical diagnosis of symptomatic benign prostatic hyperplasia (BPH). International Prostate Symptom Score (IPSS) >10. Prostate volume >20 mL. Ability to complete study questionnaires and participate in the 12-week follow-up. No use of BPH medications within the previous 2 months or completion of an appropriate washout period. Provision of written informed consent.
Exclusion criteria:
PSA ≥4 ng/mL without prior evaluation and exclusion of prostate malignancy. History or clinical suspicion of prostate cancer. Previous prostate or lower urinary tract surgery. Acute urinary retention or current need for indwelling catheterization. Active urinary tract infection, urethral stricture, bladder stones, or neurogenic bladder. Severe renal impairment (eGFR <30 mL/min/1.73 m²) or severe hepatic impairment. Myocardial infarction or stroke within the previous 3 months. Symptomatic hypotension, unstable cardiovascular disease, or uncontrolled diabetes. Symptomatic hypotension or unstable cardiovascular disease. Uncontrolled diabetes mellitus. Current use of nitrates or medications with clinically significant interactions with tadalafil. Known hypersensitivity or contraindication to tamsulosin or tadalafil.
Age
From 50 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were recruited using convenience sampling. Treatment codes were prepared and placed in blinded packages before the start of the study. After eligibility screening and obtaining written informed consent, participants were sequentially entered into the predetermined randomization sequence according to their order of enrollment. Participants were randomly allocated in a 1:1 ratio to the intervention or control group using block randomization with a block size of four. The corresponding treatment assignment was placed in a sequentially numbered, opaque, sealed envelope and will be performed by an independent urologist who is not involved in the research team.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of Medicine, Shahid Beheshti University of Medical Sciences, Koodak‑Yar Street, Daneshjoo Boulevard, Velenjak,Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2026-07-28, 1405/05/06
Ethics committee reference number
IR.SBMU.MSP.REC.1405.319

Health conditions studied

1

Description of health condition studied
Benign Prostatic Hyperplasia; BPH
ICD-10 code
N40
ICD-10 code description
Enlarged prostate

Primary outcomes

1

Description
Lower urinary tract symptoms (LUTS)
Timepoint
Lower urinary tract symptoms will be evaluated at baseline (prior to treatment) and at 12 weeks following treatment.
Method of measurement
Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score (IPSS) questionnaire. This validated instrument evaluates the severity of urinary obstructive and irritative symptoms, with higher scores indicating greater symptom severity.

2

Description
Sexual function
Timepoint
Sexual function will be assessed at baseline and 12 weeks after treatment.
Method of measurement
Sexual function will be evaluated using the International Index of Erectile Function (IIEF) questionnaire. This 15-item instrument assesses erectile function and sexual satisfaction.

Secondary outcomes

1

Description
Peak urinary flow rate (Qmax)
Timepoint
Peak urinary flow rate will be assessed at baseline and at 12 weeks following treatment.
Method of measurement
Peak urinary flow rate will be measured by uroflowmetry. The outcome will be reported as milliliters per second (mL/s).

2

Description
Post-void residual urine volume
Timepoint
Postvoid residual urine volume will be assessed at baseline and at 12 weeks after treatment.
Method of measurement
Postvoid residual urine volume will be measured using a urinary catheter.

Intervention groups

1

Description
Intervention group 1:Participants will receive 0.4 mg of tamsulosin from Actover brand daily for 12 weeks.
Category
Treatment - Drugs

2

Description
Intervention group 2: Participants will receive an alternating regimen of tadalafil 5 mg (Mofid) and tamsulosin 0.4 mg (Actover) on alternate days for 12 weeks, such that one medication (tadalafil or tamsulosin) is taken each day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Urology Clinic, Modares Hospital
Full name of responsible person
Dr. Bahram Bandeh Yazdani
Street address
Saadat Abad Intersection, Yadegar-e Imam Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 23515
Email
pr_modarres@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaei
Street address
Third Floor, School of Medicine, beside Taleghani Hospital, Evin, Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Soleimani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shahid Modarres Hospital, Yadegar-e Imam Expressway, Saadat Abad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2204 7021
Email
mohamad.soleimani.md@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Soleimani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shahid Modarres Hospital, Yadegar-e Imam Expressway, Saadat Abad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2204 7021
Email
mohamad.soleimani.md@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Saeed Azizollahi
Position
Assistant student
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Shahid Modarres Hospital, Yadegar-e Imam Expressway, Saadat Abad Intersection, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 93991981878
Email
SA.azizollahi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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