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

Assiut University

Status: Not yet enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Alpha Blockers; Drug: Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors; Drug: Phosphodiesterase 5 Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT05236634

Drug therapies in BPH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 45 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Drug: Alpha Blockers

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Phosphodiesterase 5 Inhibitors

Group C

Active Comparator group

Description:

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

Treatment:

Drug: Combined Alpha Blockers and Phosphodiesterase 5 Inhibitors