Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia

• Conditions: Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia
• Interventions: Drug: Tadalafil 5mg

• Registration Number: NCT04577040
• Lead Sponsor: Menoufia University

Brief Summary

To study Safety and efficacy of Tadalafil vs. Tadalafil with Sildosin in the management of moderately and severely symptomatic patients of prostatic hyperplasia

Detailed Description

Introduction Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in middle-aged and elderly men, and the incidence rate of LUTS associated with BPH (LUTS/BPH) increases with age.

LUTS can be broadly grouped into: (i) storage symptoms, such as frequency, urgency, and nocturia (ii) voiding symptoms, such as intermittency, weak stream and straining, and (iii) post-micturition symptoms, such as a feeling of incomplete emptying and post micturition dribble.

For optimal management of LUTS/BPH, medications should be chosen based on age, disease progression, need for long-term management, and other clinical parameters.

Alpha 1 adreno-receptors antagonists (alpha 1 blockers) are proposed as first-line drug therapy for LUTS/BPH as these agents reduce the adrenergic tone of the smooth muscle within the prostate and bladder neck, thereby relieving the bladder outlet obstruction.

Tadalafil (phosphodiesterase type 5 \[PDE-5\] inhibitor) was approved for treating LUTS/BPH. The inhibition of PDE-5leads to accumulation of cyclic guanosine monophosphate in the smooth muscles of the prostate and urethra which causes their relaxation resulting in alleviation of the symptoms of LUTS/BPH.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-30
• Study Start: 2020-10-01
• Study First Submitted QC: 2020-10-05
• Last Update Submitted: 2020-10-05
• Study First Posted: 2020-10-06
• Last Update Posted: 2020-10-06
• Primary Completion: 2021-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

• Patients to be included in the study will be either:

  1. diagnosis of BPH based on abdominal ultrasound or digital rectal examination.
  2. Moderate IPSS Score between 8 : 19.
  3. severe IPSS Score between 20 : 35.
  4. post void volume > 100 c.
  5. prostate size 50 to 80 gm.
  6. 2 or more weeks of freedom or washout from any medications known to influence LUTS before enrollment.
  7. mental and physical capacity to understand and fill out the study questionnaires.

Exclusion Criteria

1. contraindications to Sildosin or Tadalafil.
2. diagnosis of prostate cancer.
3. possible presence of urinary infection, neurogenic bladder, stone bladder, refractory retention, hematuria of prostate origin or any cause for surgical intervention.
4. clinically significant cardiovascular, hepatic, or renal disorders.
5. cataract surgery planned during the study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Tadalafil 5mg	Tadalafil in moderate puts
4	Tadalafil 5mg	Tadalafil with sildosin in severe luts
2	Tadalafil 5mg	Tadalafil in severe puts
3	Tadalafil 5mg	Tadalafil with sildosin in moderate luts

Primary Outcome Measures

Name	Time	Method
Symptom relief	2 weeks	Decreased AUA score