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

NCT05236634 | Unknown

• 1 other identifier: Drug therapies in BPH
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Phosphodiesterase5 inhibitors and Alpha Blockers

Outcome Measures

Primary Outcomes (3)

• Change in International prostate symptom score (IPSS) after 12 weeks

  The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

  At start of study and after 12 weeks from drug intake

• Change in International index of erectile function (IIEF) after 12 weeks

  The International Index of Erectile Function (IIEF) is a widely used, multi-dimensional self-report instrument for the evaluation of male sexual function. It is has been recommended as a primary endpoint for clinical trials of erectile dysfunction (ED) and for diagnostic evaluation of ED severity.

  At start of study and after 12 weeks from drug intake

• Change in Maximal urinary flow rate (Qmax) after 12 weeks

  The flow rate is calculated as milliliters (ml) of urine passed per second. Both average and top flow rates are measured. The fastest flow rate, also known as Qmax, is used to understand if a block or obstruction is severe.

  At start of study and after 12 weeks from drug intake

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Drug: Alpha Blockers

Group B

ACTIVE COMPARATOR

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

Drug: Phosphodiesterase 5 Inhibitors

Group C

ACTIVE COMPARATOR

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

Drug: Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors

Interventions

Phosphodiesterase 5 Inhibitors 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.

Also known as: tadalafil 5 mg oral Tablet

Group B

Alpha Blockers 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.

Also known as: Tamsulin 0.4 mg oral tablet

Group A

Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors 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.

Also known as: Tadalafil 5 mg oral Tablet and Tamsulin 0.4 mg oral tablet

Group C

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Men \> 45 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• PSA level of \> 10.0 ng/mL (if ≥ 4.0 to≤ 10.0 ng/mL prostate cancer will be excluded).
• Post-voidresidual urine volume of ≥ 150 mL.
• Previous Urine Retention or Urethral Catheterization .
• other pathology such as urinary bladder stone , bladder mass or neurogenic bladder .
• 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).
• patients supposed to undergo intraocular operation (as cataract operation) .
• History of head injury or cerebrovascular stroke or spinal injury.
• pelvic fracture.
• Uncontrolled diabetic patient.
• Patients with chronic obstructive lung disease on medical treatment.
• Parasympatholytic drugs are contraindicated during the study. 12. Patients refusing to share in the study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Singh DV, Mete UK, Mandal AK, Singh SK. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med. 2014 Jan;11(1):187-96. doi: 10.1111/jsm.12357. Epub 2013 Oct 25.

  PMID: 24165272 BACKGROUND

• Wang XH, Wang X, Shi MJ, Li S, Liu T, Zhang XH. Systematic review and meta-analysis on phosphodiesterase 5 inhibitors and alpha-adrenoceptor antagonists used alone or combined for treatment of LUTS due to BPH. Asian J Androl. 2015 Nov-Dec;17(6):1022-32. doi: 10.4103/1008-682X.154990.

  PMID: 25994648 BACKGROUND

• Mirone V, Sessa A, Giuliano F, Berges R, Kirby M, Moncada I. Current benign prostatic hyperplasia treatment: impact on sexual function and management of related sexual adverse events. Int J Clin Pract. 2011 Sep;65(9):1005-13. doi: 10.1111/j.1742-1241.2011.02731.x. Epub 2011 Jul 1.

  PMID: 21718399 BACKGROUND

Related Links

• Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TR, Mamoulakis C, Rieken M, Speakman MJ and Tikkinen KA. (2015): Guidelines on the management of non neurogenic male (LUTS), incl. (BPO). EAU Guidelines
• Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TRW, Mamoulakis C, et al. Management of nonneurogenic male LUTS. In: EAU Guidelines 2020. Arnhem,The Netherlands: EAU Guidelines Office; 2020. Available from:https://uroweb.org/guideline/treatment-of-non

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Phosphodiesterase 5 Inhibitors; Tadalafil; Tablets; Adrenergic alpha-Antagonists

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Dosage Forms; Pharmaceutical Preparations; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs

Study Officials

• Mohamed E Osman, MD

  Assiut University, Urology department, Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Ahmed M Hussein, Master

CONTACT

01004744048; ahmedawd99991@gmail.com

Nasreldin A Mohamed, MD

CONTACT

01061635080; nasreldin@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 11, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 30, 2024
• Last Updated: February 11, 2022

Record last verified: 2022-02