Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

Handok

Status and phase

Completed

Phase 4

Conditions

Prostatic Hyperplasia

Treatments

Drug: ALFUZOSIN

Study type

Interventional

Funder types

Industry

Identifiers

NCT00427882

ALFUS_L_01778

Details and patient eligibility

About

Primary:

To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.

Secondary:

To evaluate sexual function improvement
To evaluate LUTS (Lower Uninary Tract Symptoms) improvement
To evaluate the association between LUTS severity and sexual function.
To assess the safety and the tolerability of Alfuzosin 10mg OD.

Enrollment

125 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
Patients with an I-PSS total score ≥ 8
Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation

Exclusion criteria

Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
Patients who had a previous prostate surgery
Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
Patients with a prostate surgery or minimally invasive procedure during the whole study period
Patients with an active urinary tract infection or prostatitis
Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
Patients with a diagnosed prostate cancer
Patients having received 5a-reductase inhibitors or LUTS related-phytotherapy within 6 months prior to inclusion, or a1-blockers within 30 days prior to inclusion
Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
Patients with a history of postural hypotension or syncope
Patients with a known hypersensitivity to alfuzosin