On-demand Silodosin 4mg vs Dapoxetine 60mg in the Treatment of Primary Premature Ejaculation
Phase: PHASE2
Conditions: Premature (Early) Ejaculation
Sponsor: Benha University

 
 
 
 
 
 
 
 
 
 On demond Sildosin 4mg VS Dapoxitine 
60mg In Treatment Of  primary 
Premature  Ejaculation  
 
Date 1-3-2024
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Introduction 

 
 
Premature ejaculation (PE) is a common sexual problem 
encountered by men in day-to-day clinical practice. It affects about 20-
30% of men in the sexually active age group. PE is a commonly used term, 
but it is more appropriately called early ejaculation or rapid ejaculation 
(Raveendran and Agarwal, 2021). 
PE means ejaculation occurs within one minute during the sexuality 
with sex partner after inserting into the vagina, and this symptom lasts for 
at least 6 months. PE is defined by The American Urology Association as 
“ejaculation occurring sooner than desired causing distress to one or both 
partners” (Gillman and Gillman, 2019). 
The etiology of PE is complex, and its pathogenesis is still unclear. 
It’s believed that this disease is mostly related to psychological factors. 
The persistent unhealthy psychological factors may aggravate potential 
abnormal organic factors, which lead to the occurrence of premature 
ejaculation (Coskuner and Ozkan, 2022). 
While PE is a common sexual dysfunction affecting all age groups, 
it is more prominent in older age groups and more commonly associated 
with other medical conditions like diabetes. Primary PE can be triggered 
by psychological impulses like conditioning, upbringing, or traumatic 
sexual experience. Secondary PE can be triggered by diabetes, 
hypertension, hyperthyroidism, alcoholism, or use of recreational drugs 
(Raveendran and Agarwal, 2021). 
According to the time when the symptom of PE occurs, this disease 
could be divided into two types which are named preliminary premature 
ejaculation and acquired premature ejaculation (Pereira-Lourenço et al., 
2019). 
PE causes psychological stress and loss of self-esteem, resulting in 
significant adverse effects on the quality of life, of both the patient and the 
partner. So, present therapeutic schedule mainly includes psychological 

 
 
therapy, behavioral therapy, drug therapy and Chinese medicine. These 
therapies could be used alone or in combination, and relevant literature has 
reported certain clinical effects.  
However, there are still many problems such as large side effects, 
high recurrence rate, and long-term efficacy uncertainty, which need to 
concentrate on (Abbas et al., 2023). 
Thus, pharmacotherapy should in theory be the treatment of choice for 
patients with lifelong PE (Waldinger MD, et al .,2020) . 
Dapoxetine is a selective serotonin reuptake inhibitor, is the first oral 
pharmacological agent indicated for the treatment of men aged 18-64 years 
with premature ejaculation. (N Engl J Med. 2019). 
 Dapoxetine is the only effective and safe available on-label oral 
treatment for PE, and its use can result in better quality of life for the 
patient and their sexual partner. (N Engl J Med. 2019). 
Oral dapoxetine 60 mg (administered as needed) was effective in the 
treatment of men with premature ejaculation, inducing significantly greater 
improvements. (N Engl J Med. 2019). 
Silodosin is a selective alpha-1a adrenergic antagonist used in the 
therapy of benign prostatic hypertrophy. Silodosin is associated with a low 
rate of serum aminotransferase elevations and to rare instances of clinically 
apparent acute liver injury. (N Engl J Med. 2019). 
Silodosin inhibits alpha adrenergic receptors present on smooth 
muscle in the bladder neck and prostate (alpha-1a adrenergic receptors)(N 
Engl J Med. 2019). 
Compared with other α1-adrenoceptor antagonists, silodosin appeared 
to suppress ejaculation in a relatively higher percent of trial participants. 

 
 
This suppression of ejaculation by silodosin suggested its potential for 
treating premature ejaculation and it seemed to be more effective for 
preventing PE than other alpha blockers. (Sato Y, Otani T,et al. 2017). 
 
 
 
  
.   
 
 
 
 

 
 
Aim of the Work 
The aim of this study is to assess  efficacy and tolerability of 
Silodosin 4mg vs Dapoxitine 60mg in treatment of primary premature 
ejaculation. 
 
 
 
 
 

 
 
Patients and Methods 
A prospective study will be carried out on 50 patients with 
premature ejaculation who attending outpatient clinic, urology department, 
Benha university hospitals over a period of 6 months starting from 
approval of the institutional ethical committee. 
An informed written consent will be obtained from the patients. 
Every patient will receive an explanation of the purpose of the study and 
will have a secret code number. 
Research results will only be used for scientific purposes. Any 
unexpected risks appearing during research will be clarified to the 
participants and to the ethical committee on time. 
Inclusion Criteria:  
• Age > 18 years old. 
• Patients with primary premature ejaculation (PPE) according to 
(IELT > 1 min) 
• Sexually active. 
• Heterosexual. 
• The course of suffering from PE is ≥6 months. 
Exclusion criteria: 
• History of diabetes and other diseases.  
• Uncontrolled hypertension (HTN) (systolic ≥ 140 mmHg or 
diastolic ≥ 90 mmHg). 
• Patients having anatomic abnormalities of the penis or genital region  
• Patients’ refusal. 
• Patients with erectile dysfunction. 
• Patient with chronic prostatitis. 
• Patient with psychologically disorder. 
• Patient on anti-psychiatric drugs. 

 
 
Study design: 
Patients who meet the previous criteria will be enrolled in the study.  
We randomly assigned 80 outpatients with PPE to two groups , 
group A (sildosin 4mg)  40 patients and group B (dapoxatine 60mg) 40 
patients . 
Methods: 
All patients meeting the above-mentioned criteria will be subjected 
to the following: 
1. Full history taking including:  
Personal, present, past, family, and surgical histories of the patients 
will be documented. This includes collecting information about the 
patient's demographics, current health status, medical history, family 
medical history, and any prior surgical procedures. 
2. Clinical Examination: 
A thorough clinical examination of the patients will be conducted to 
evaluate their general health and assess any physical signs and symptoms 
related to premature ejaculation or other conditions. 
Group A (sildosin 4 mg): intake 2h before intercourse (on 
demand) at least 6 times intercourse /month for 2 months. 
Group B (dapoxatine 60mg): the same like sildosin. 
 
Follow up patients will be evaluated by by PEP (premature ejaculatory 
profile) & IELT. (intravaginal latency time) 2 months after start of 
treatment. 
Intravaginal ejaculatory latency time (IELT): normal duration 2.5- 5 
minutes. ( Waldinger MD, et al .2005). 
scores of the Premature Ejaculation Profile (PEP): to evaluate the 
reliability and validity of the Premature Ejaculation Profile (PEP), The 

 
 
PEP contains four measures: perceived control over ejaculation, personal 
distress related to ejaculation, satisfaction with sexual intercourse, and 
interpersonal difficulty related to ejaculation, each assessed on five-point 
response scales. (Patrick DL, et al .,2009). 
Any side effects of drugs will be recognized and recorded. 
 
 

 
 
Ethical considerations: 
1. An approval from the Research Ethics Committee of faculty 
of medicine will be obtained. 
2. An informed written consent from all patients or first-degree 
relatives before participation will be obtained; it will include 
data about aim of the work, study design, site, time, subject 
and methods, confidentiality. 
3. Official permission will be obtained from the Dean of Faculty 
of Medicine and the administrators of University Hospitals to 
conduct this study. 
 
 

 
 
 
Results 
The results will be tabulated, correlated and statistically analyzed to 
fulfill the aim of the work.  
Statistical analysis  
We will use IBM's Statistical Package for the Social Sciences (2017, 
Released) to edit, code, and tabulate the data we gathered. IBM Corp., 
Armonk, New York, USA: IBM SPSS Statistics for Windows, Version 
25.0. To ensure that the data was distributed normally, the Shapiro-Wilk 
test was employed. Each parameter's data type informed the presentation 
and analysis of the corresponding data. Nominal data were expressed as 
mean ± SD. For categorical data, percentages and frequencies were 
employed. The statistical significance of a difference between two study 
groups for parametric variables was assessed using an independent samples 
t-test, and for non-parametric variables, the Mann Whitney Test (U test) 
was employed. We looked examined the correlation between the two 
qualitative variables using the Chi-Square test. At a 95% confidence 
interval, a p-value is deemed significant if it is less than 0.05. 
 
 
 

 
 
References 
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Coskuner, E. R. & Ozkan, B. 2022. Premature Ejaculation and Endocrine 
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Gillman, N. & Gillman, M. 2019. Premature Ejaculation: Aetiology and 
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