Clinical trial NCT00427882: Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study
Official title: An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 125
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Mean change from baseline to the end of treatment in the MSHQ ejaculation total score
Secondary outcomes:
measure: Mean change from baseline to 4 weeks in MSHQ ejaculation total score
measure: Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score
measure: Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores
measure: Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life
measure: Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms
measure: Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax)
measure: Correlation between MSHQ and IPSS
measure: Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Handok
Study officials:
affiliation: Handok Inc.
name: Hyou-Young Rhim, Dr.
role: STUDY_DIRECTOR
References: