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Status unknownNCT04577040Updated Oct 6, 2020

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

An observational study in Safety and Efficacy of Tadalafil vs. Tadalafil With Sildosin in the Management of Moderately and Severely Symptomatic Patients of Prostatic Hyperplasia, sponsored by Menoufia University. Status unknown. Open to male participants aged 45 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-10-06.

Sponsored by Menoufia University · Observational

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
45 Years to 99 Years
Sex
Male
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Study summary

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

Read the 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.

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Conditions studied

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

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's planned enrollment of 400 is above the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 99 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Middle and old aged males

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 1

    Tadalafil in moderate puts

    Drug: Tadalafil 5mg

  • 2

    Tadalafil in severe puts

    Drug: Tadalafil 5mg

  • 3

    Tadalafil with sildosin in moderate luts

    Drug: Tadalafil 5mg

  • 4

    Tadalafil with sildosin in severe luts

    Drug: Tadalafil 5mg

Interventions

  • DrugTadalafil 5mg

    Drugs

    Also known as: Sildosin

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What researchers measure

Primary outcomes

  1. Symptom relief

    Decreased AUA score

    Time frame: 2 weeks

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04577040
Lead sponsor
Menoufia University
Responsible party
Mohamed Yaseen (Menoufia governorate, Menoufia University) — Principal investigator
First posted
Oct 6, 2020
Start date
Oct 1, 2020 (estimated)
Primary completion
Oct 1, 2021 (estimated)
Completion
Oct 1, 2022 (estimated)
Last update
Oct 6, 2020

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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