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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phosphodiesterase 5 Inhibitors
Alpha Blockers
Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Phosphodiesterase5 inhibitors and Alpha Blockers

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2022
    Last Updated
    February 10, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05236634
    Brief Title
    (Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia
    Official Title
    Comparative Study Between Fixed Dose Monotherapy (Phosphodiesterase 5 Inhibitors or Alpha Blockers) Versus Combined Therapy in Benign Prostatic Hyperplasia Patients With Lower Urinary Tract Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia
    Keywords
    Phosphodiesterase5 inhibitors and Alpha Blockers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Forty patients with LUTS due to BPH will be given tamsulosin 0.4 mg for 12 weeks.
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Forty patients with LUTS due to BPH will be given tadalafil 5 mg for 12 weeks.
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    Forty patients with LUTS due to BPH will be given combined therapy(tamsulosin 0.4 mg and tadalafil 5 mg) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Phosphodiesterase 5 Inhibitors
    Other Intervention Name(s)
    tadalafil 5 mg oral Tablet
    Intervention Description
    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
    Intervention Name(s)
    Alpha Blockers
    Other Intervention Name(s)
    Tamsulin 0.4 mg oral tablet
    Intervention Description
    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
    Intervention Name(s)
    Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors
    Other Intervention Name(s)
    Tadalafil 5 mg oral Tablet and Tamsulin 0.4 mg oral tablet
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in International prostate symptom score (IPSS) after 12 weeks
    Description
    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.
    Time Frame
    At start of study and after 12 weeks from drug intake
    Title
    Change in International index of erectile function (IIEF) after 12 weeks
    Description
    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.
    Time Frame
    At start of study and after 12 weeks from drug intake
    Title
    Change in Maximal urinary flow rate (Qmax) after 12 weeks
    Description
    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.
    Time Frame
    At start of study and after 12 weeks from drug intake

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Men > 45 years
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed M Hussein, Master
    Phone
    01004744048
    Ext
    002
    Email
    ahmedawd99991@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nasreldin A Mohamed, MD
    Phone
    01061635080
    Ext
    002
    Email
    nasreldin@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed E Osman, MD
    Organizational Affiliation
    Assiut University, Urology department, Faculty of Medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24165272
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25994648
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21718399
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/#1
    Description
    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
    URL
    https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts/.
    Description
    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

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

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