Impact of Tadalafil 5 mg on Post-micturition Dribble in Young-age Men With no/Mild Lower Urinary Tract Symptoms

NCT05146674 | Unknown

• 1 other identifier: AS-11-2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of tadalafil 5 mg on post-micturition dribble (PMD) in young age men (18-50 years) with no/mild lower urinary tract symptoms (LUTS).

Conditions

Lower Urinary Tract Symptoms

Keywords

Post-micturition dribble; Lower urinary tract symptoms; Tadalafil; Quality of life

Outcome Measures

Primary Outcomes (1)

• Improvement of post-micturition dribble

  Improvement of PMD is defined as improvement by Hallym Post-Micturation Dribble Questionnaire (HPMDQ) score will decrease by 2 points or more

  12 weeks

Secondary Outcomes (3)

• Post micturition dribble volume

  12 weeks

• Erectile function

  12 weeks

• Lower urinary tract symptoms

  12 weeks

Study Arms (2)

Tadalafil group

ACTIVE COMPARATOR

Our prospective, randomized, study will consist of a 1-week baseline period and 12-week double-blind treatment period During the baseline period, patients' characteristics, including medical and sexual history, physical examination results, vital signs, HPMDQ score, IPSS, International Index of Erectile Function (IIEF) score, PMD volume, and uroflowmetry results; and laboratory results, including urine analysis results, will be recorded. After the baseline period, patients will be randomly assigned, 1:1, to the treatment or control groups using a computer-generated system. Both study groups will be advised to do bulbar urethral massage in addition to pelvic floor muscle exercise (explained later) during the study period, treatment group will be given tadalafil 5 mg (treatment group) daily or no medication (control group).

Drug: Tadalafil 5mg

Control group

NO INTERVENTION

Our prospective, randomized, study will consist of a 1-week baseline period and 12-week double-blind treatment period During the baseline period, patients' characteristics, including medical and sexual history, physical examination results, vital signs, HPMDQ score, IPSS, International Index of Erectile Function (IIEF) score, PMD volume, and uroflowmetry results; and laboratory results, including urine analysis results, will be recorded. After the baseline period, patients will be randomly assigned, 1:1, to the treatment or control groups using a computer-generated system. Both study groups will be advised to do bulbar urethral massage in addition to pelvic floor muscle exercise (explained later) during the study period, treatment group will be given tadalafil 5 mg (treatment group) daily or no medication (control group).

Interventions

Tadalafil 5mg DRUG

Our prospective, randomized, study will consist of a 1-week baseline period and 12-week double-blind treatment period During the baseline period, patients' characteristics, including medical and sexual history, physical examination results, vital signs, HPMDQ score, IPSS, International Index of Erectile Function (IIEF) score, PMD volume, and uroflowmetry results; and laboratory results, including urine analysis results, will be recorded. After the baseline period, patients will be randomly assigned, 1:1, to the treatment or control groups using a computer-generated system. Both study groups will be advised to do bulbar urethral massage in addition to pelvic floor muscle exercise (explained later) during the study period, treatment group will be given tadalafil 5 mg (treatment group) daily or no medication (control group).

Tadalafil group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients (aged 19-50 years) 2- Complaining from PMD with no or mild LUTS (IPSS\<8).

You may not qualify if:

• Patients with penile or urethral malformations 2- Patients recently received PDE5Is in the last 4 weeks prior to study start. 3- Systemic illness 4- Contraindications to PDE5Is. 5- History of pelvic surgery or irradiation 6- History of bladder or prostate surgery 7- Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Urology and Nephrology Center

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Amr A Elsawy

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr A Elsawy

CONTACT

01009428750; amrelsawy.unc@hotmail.com

Mahmoud Laymon

CONTACT

dr_mahmoudlaymon@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

EG (1)