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

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Middle and old aged males

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Tadalafil in moderate puts	Drug: Tadalafil 5mg; Drugs; Other Names: Sildosin
2; Tadalafil in severe puts	Drug: Tadalafil 5mg; Drugs; Other Names: Sildosin
3; Tadalafil with sildosin in moderate luts	Drug: Tadalafil 5mg; Drugs; Other Names: Sildosin
4; Tadalafil with sildosin in severe luts	Drug: Tadalafil 5mg; Drugs; Other Names: Sildosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom relief	Decreased AUA score	2 weeks

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: 10-2020urol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No