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

Overview

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).

Full Title of Study: “Impact of Tadalafil 5 mg on Post-micturition Dribble in Young-age Men With no/Mild Lower Urinary Tract Symptoms: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 1, 2022

Detailed Description

Post-micturition dribble (PMD), a post-voiding symptom, is defined as involuntary loss of urine immediately after urination. It is more common in males. Many population/practice-based studies have shown that PMD is one of the most common bothersome urinary symptoms in adult males ranging from 5.5 % to 29 %. (1, 2) In young age men (less than 50 years) with absence of prostate-associated lower urinary tract symptoms (LUTS), PMD is considered the most devastating urinary complaint with worsened physical and mental health-related quality of life (HRQoL). (3) Pathophysiology of PMD is usually attributed to residual urine in the bulbar urethra whatever the cause. Many theories, including weakness or failure of the pelvic floor muscles, incompetency of the external urethral sphincter or bladder neck obstruction, were suggested for this urine residue. (4) However, in patients with PMD with no/mild LUTS, pelvic floor muscle weakness especially the bulbocavernosus and ischiocavernosus muscles is usually the main putative mechanism. (5) Bulbar urethral massage and pelvic floor muscle exercise have been proposed as useful options for patients with PMD (6); yet, pharmacological treatment has not been standardized for those patients. In this perspective, recent studies have shown that corpus cavernosum structural changes may be related to PMD. (7) It is well known that phosphodiesterase-5 (PDE-5) isoenzymes are highly expressed in the urethra as well as the corpus cavernosum, bladder and prostate. (8) In addition, once-daily 5 mg tadalafil, a PDE-5 inhibitor, has previously been used to treat voiding and storage LUTS. In addition, tadalafil once daily showed reduced PMD symptom severity and PMD volume in men with PMD and other LUTS. (9) Notably, this study included old age men (mean age 62 years) with moderate or severe LUTS. The aim of the present study was to compare the effects of taking tadalafil 5 mg once daily on PMD in young men (18-50 years) with minimal/mild LUTS.

Interventions

  • Drug: Tadalafil 5mg
    • 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).

Arms, Groups and Cohorts

  • Active Comparator: Tadalafil group
    • 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).
  • No Intervention: Control group
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Improvement of post-micturition dribble
    • Time Frame: 12 weeks
    • Improvement of PMD is defined as improvement by Hallym Post-Micturation Dribble Questionnaire (HPMDQ) score will decrease by 2 points or more

Secondary Measures

  • Post micturition dribble volume
    • Time Frame: 12 weeks
    • Impact of treatment on PMD volume
  • Erectile function
    • Time Frame: 12 weeks
    • Impact of treatment on erectile function as assessed by international index of erectile function (IIEF)
  • Lower urinary tract symptoms
    • Time Frame: 12 weeks
    • Impact of treatment on LUTS as assessed by International prostate symptoms score (IPSS)

Participating in This Clinical Trial

Inclusion Criteria

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

  • 1- 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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amr Abdel-Lateif El-Sawy, Lecturer of Urology – Mansoura University
  • Overall Official(s)
    • Amr A Elsawy, Principal Investigator, Mansoura University
  • Overall Contact(s)
    • Amr A Elsawy, 01009428750, amrelsawy.unc@hotmail.com

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