Efficacy and Safety of Tadalafil, Tamsulosin, and Their Combinations in Treating Lower Urinary Tract Symptoms in BPH Patients with Prostate Volumes ≤ 40 Ml: a Prospective Comparative Study

NCT06809205 | Completed Phase 4

• 1 other identifier: R 450
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract: Objective: To examine the influence of tadalafil and tamsulosin versus their combinations in the treatment of lower urinary tract symptoms in mildly enlarged prostates below 40 ml in volume. Materials and methods: A prospective randomized study was done at Fayoum and Beni-Suef University Hospitals in Egypt from December 2022 to August 2023. A total of 95 male participants aged over 45 years, all presenting with mild to intense lower urinary tract symptoms, were enrolled. Participants were randomized into three groups: Group A was administered Tamsulosin (0.4 mg per day), Group B was administered tadalafil (5 mg per day), and Group C was administered a mixture of both medications. The study assessed multiple parameters, the primary endpoint parameter was the International Prostate Symptom Score (IPSS) and the other secondary parameters were the five-item International Index of Erectile Function (IIEF-5), maximum urinary flow rate (Q-max), post-void residual urine (PVR), and the quality of life (QoL). At baseline, these parameters were assessed, followed by evaluations at 1, 3, and 6 months after treatment. Key words. Tamsulosin, tadalafil, BPH and LUTS.

Conditions

BPH with Other Lower Urinary Tract Symptoms

Keywords

Tamsulosin, tadalafil, BPH and LUTS

Outcome Measures

Primary Outcomes (1)

• IPSS (International Prostate Symptom Score)

  The International Prostate Symptom Score (IPSS) is a questionnaire used to assess the severity of symptoms related to the lower urinary tract, often associated with conditions like benign prostatic hyperplasia (BPH) in men. It helps healthcare providers determine the severity of symptoms, monitor changes over time, and guide treatment decisions. The IPSS consists of 8 questions, covering symptoms such as: Incomplete Emptying: Feeling that the bladder is not fully emptied after urination. Frequency: How often you feel the need to urinate. Intermittency: Whether urine flow starts and stops during urination. Urgency: How urgently you need to urinate. Weak Stream: The strength of the urine stream. Straining: How much effort is needed to urinate. Nocturia: How many times you wake up at night to urinate. Quality of Life: General assessment of how urinary symptoms affect your quality of life. Each question is rated on a scale from 0 (no symptoms) to 5

  at presentation, 1,3 and 6 month after treatment

Secondary Outcomes (4)

• IIEF-5 (five-item International Index of Erectile Function)

  at presentation, 1,3 and 6 month after treatment

• Q-max (maximum urinary flow rate)

  at presentation, 1,3 and 6 month after treatment

• PVR (post-void residual urine)

  at presentation, 1,3 and 6 month after treatment

• QoL (quality of life)

  at presentation, 1,3 and 6 month after treatment

Study Arms (3)

Group A

EXPERIMENTAL

Group A was administered Tamsulosin (0.4 mg per day)

Drug: Tamsulosin 0.4 mg

Group B

EXPERIMENTAL

Group B was administered tadalafil (5 mg per day)

Drug: Tadalafil 5mg

group c

EXPERIMENTAL

administered tadalafil and tamsulosin 0.4 mg

Drug: Tamsulosin and Tadalafil

Interventions

Tamsulosin 0.4 mg DRUG

administered tamsulosin 0.4 mg

Also known as: group A

Group A

Tadalafil 5mg DRUG

administered tadalafil 5 mg

Also known as: group B

Group B

Tamsulosin and Tadalafil DRUG

administered tamsulosin 0.4 mg plus tadalafil 5 mg

Also known as: Group C

group c

Eligibility Criteria

• Age: 45 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Mohamed Mahmoud Dogha

Al Fayyum, Fayoum Governorate, 63514, Egypt

Location

Related Publications (5)

• Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.

  PMID: 25613154 BACKGROUND

• MacDonald R, Brasure M, Dahm P, Olson CM, Nelson VA, Fink HA, Risk MC, Rwabasonga B, Wilt TJ. Efficacy of newer medications for lower urinary tract symptoms attributed to benign prostatic hyperplasia: a systematic review. Aging Male. 2019 Mar;22(1):1-11. doi: 10.1080/13685538.2018.1434503. Epub 2018 Feb 2.

  PMID: 29394114 BACKGROUND

• Morton A, Williams M, Perera M, Teloken PE, Donato P, Ranasinghe S, Chung E, Bolton D, Yaxley J, Roberts MJ. Management of benign prostatic hyperplasia in the 21st century: temporal trends in Australian population-based data. BJU Int. 2020 Sep;126 Suppl 1:18-26. doi: 10.1111/bju.15098. Epub 2020 Jun 17.

  PMID: 32558340 BACKGROUND

• Yamanishi T, Kaga K, Sakata K, Yokoyama T, Kageyama S, Fuse M, Tokunaga S. A randomized controlled study of the efficacy of tadalafil monotherapy versus combination of tadalafil and mirabegron for the treatment of persistent overactive bladder symptoms in men presenting with lower urinary tract symptoms (CONTACT Study). Neurourol Urodyn. 2020 Feb;39(2):804-812. doi: 10.1002/nau.24285. Epub 2020 Jan 21.

  PMID: 31961963 BACKGROUND

• Michel MC, Vrydag W. Alpha1-, alpha2- and beta-adrenoceptors in the urinary bladder, urethra and prostate. Br J Pharmacol. 2006 Feb;147 Suppl 2(Suppl 2):S88-119. doi: 10.1038/sj.bjp.0706619.

  PMID: 16465187 BACKGROUND

Related Links

• EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction.
• Efficacy of newer medications for lower urinary tract symptoms attributed to benign prostatic hyperplasia: a systematic review. Aging Male.
• Management of benign prostatic hyperplasia in the 21st century: temporal trends in Australian population-based data.
• A randomized controlled study of the efficacy of tadalafil monotherapy versus combination of tadalafil and mirabegron for the treatment of persistent overactive bladder symptoms in
• Alpha1-, alpha2- and beta-adrenoceptors in the urinary bladder, urethra and prostate.

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology- faculty of medicine- fayoum university

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 5, 2025
• Study Start: April 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: August 30, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)