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

Menoufia University

Status: Unknown

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

Treatments: Drug: Tadalafil 5mg

Study type: Observational

Funder types: Other

Identifiers

NCT04577040

10-2020urol

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 45 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 4 patient groups

1

Description:

Tadalafil in moderate puts

Treatment:

Drug: Tadalafil 5mg

2

Description:

Tadalafil in severe puts

Treatment:

Drug: Tadalafil 5mg

3

Description:

Tadalafil with sildosin in moderate luts

Treatment:

Drug: Tadalafil 5mg

4

Description:

Tadalafil with sildosin in severe luts

Treatment:

Drug: Tadalafil 5mg