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

NCT ID: NCT04577040

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-10-01

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Tadalafil in moderate puts

Tadalafil 5mg

Intervention Type: DRUG

Drugs

2

Tadalafil in severe puts

Tadalafil 5mg

Intervention Type: DRUG

Drugs

3

Tadalafil with sildosin in moderate luts

Tadalafil 5mg

Intervention Type: DRUG

Drugs

4

Tadalafil with sildosin in severe luts

Tadalafil 5mg

Intervention Type: DRUG

Drugs

Interventions

Tadalafil 5mg

Drugs

Intervention Type: DRUG

Other Intervention Names

Sildosin

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Yaseen

Menoufia governorate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

10-2020urol

Identifier Type: -

Identifier Source: org_study_id