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

October 5, 2020 updated by: Mohamed Yaseen, Menoufia University
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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 97 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 weeks
Decreased AUA score
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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