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