(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

NCT00970632

Benign Prostatic Hyperplasia (BPH)

COMPLETED PHASE3

Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia

NCT06466369

BPH With Other Lower Urinary Tract Symptoms

COMPLETED PHASE3

Efficacy of Tadalafil/Solifenacin VS Tamsulosin/Solifenacin Combination Therapy for BPH/OAB

NCT05494567

Benign Prostatic Hyperplasia Overactive Bladder

UNKNOWN PHASE4

Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

NCT00540124

Benign Prostatic Hyperplasia

COMPLETED PHASE2

A Study in Benign Prostatic Hyperplasia

NCT01152190

Benign Prostatic Hyperplasia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The proposed research aims to answer the question about efficacy and safety of phosphodiesterase 5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia .

Benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the non-malignant hyperplasia of prostatic cells. Most of patients with BPH present with lower urinary tract symptoms (LUTS). About half of men develop BPH, among those; about half develop some degree of bladder outlet obstruction (BOO). BOO and/or changes in smooth muscle tone and resistance that can accompany BPH may result in (LUTS).

Alpha-blockers have been widely used for the treatment of LUTS/BPH for a long time. Some alpha-blockers may cause ejaculatory dysfunction in some individuals. Tadalafil, a (PDE-5), was approved by the Food and Drug Administration (FDA) for the treatment of (ED) in 2003 and for the treatment of BPH in 2011.

The PDE5 inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH.

Medical treatments for LUTS/BPH are able to significantly impact on sexual function. Sexual side effects like ejaculatory dysfunction, reduced or lost libido, and ED have been widely reported in patients treated with alpha blockers (ABs) and 5-alpha reductase inhibitors, the most utilized drugs for the treatment of LUTS/BPH.

The inclusion of Tadalafil in complex of combined conservative therapy of patients with BPH not only improves sexual function but has a positive effect on symptoms of the disease and the psychological state of the patient.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostatic Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into 3 groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks.

Group Type ACTIVE_COMPARATOR

Alpha Blockers

Intervention Type DRUG

A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Group B

Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks.

Group Type ACTIVE_COMPARATOR

Phosphodiesterase 5 Inhibitors

Intervention Type DRUG

A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Group C

Forty patients with LUTS due to BPH will be given combined therapy(tamsulosin 0.4 mg and tadalafil 5 mg) for 12 weeks.

Group Type ACTIVE_COMPARATOR

Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors

Intervention Type DRUG

A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phosphodiesterase 5 Inhibitors

A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Intervention Type DRUG

Alpha Blockers

A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Intervention Type DRUG

Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors

A total of (120) patients with LUTS due to BPH fulfilling the inclusion criteria will be included in this study. Patients will be randomly divided into three groups: Group A: Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks. Group B: Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks. Group C: Forty patients with LUTS due to BPH will be given combined therapy for 12 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tadalafil 5 mg oral Tablet Tamsulin 0.4 mg oral tablet Tadalafil 5 mg oral Tablet and Tamsulin 0.4 mg oral tablet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1 - Men \> 45 years with LUTS/BPH for \> 6 months 2- IPSS of ≥ 8 and Qmax of ≥ 4 to≤ 15 mL/s

Exclusion Criteria

1. PSA level of \> 10.0 ng/mL (if ≥ 4.0 to≤ 10.0 ng/mL prostate cancer will be excluded).
2. Post-voidresidual urine volume of ≥ 150 mL.
3. Previous Urine Retention or Urethral Catheterization .
4. other pathology such as urinary bladder stone , bladder mass or neurogenic bladder .
5. Any case of LUTS other than BPH (urinary bladder stone, neurogenic bladder, bladder neck contracture,rethral stricture, bladder cancer, acute or chronic prostatitis, acute or chronic urinary tract infection).
6. patients supposed to undergo intraocular operation (as cataract operation) .
7. History of head injury or cerebrovascular stroke or spinal injury.
8. pelvic fracture.
9. Uncontrolled diabetic patient.
10. Patients with chronic obstructive lung disease on medical treatment.
11. Parasympatholytic drugs are contraindicated during the study. 12. Patients refusing to share in the study.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No