Clinical trial NCT05146674: Impact of Tadalafil 5 mg on Post-micturition Dribble in Young-age Men With no/Mild Lower Urinary Tract Symptoms
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: Post-micturition dribble
Lower urinary tract symptoms
Tadalafil
Quality of life
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of post-micturition dribble
timeFrame: 12 weeks
Secondary outcomes:
measure: Post micturition dribble volume
timeFrame: 12 weeks
measure: Erectile function
timeFrame: 12 weeks
measure: Lower urinary tract symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Urology and Nephrology Center
state: DK
Study officials:
affiliation: Mansoura University
name: Amr A Elsawy
role: PRINCIPAL_INVESTIGATOR
References: