Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study
Study Details
Study Description
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:
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To evaluate sexual function improvement
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To evaluate LUTS (Lower Uninary Tract Symptoms) improvement
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To evaluate the association between LUTS severity and sexual function.
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To assess the safety and the tolerability of Alfuzosin 10mg OD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Outcome Measures
Primary Outcome Measures
- Mean change from baseline to the end of treatment in the MSHQ ejaculation total score []
Secondary Outcome Measures
- Mean change from baseline to 4 weeks in MSHQ ejaculation total score []
- Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score []
- Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores []
- 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 []
- Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms []
- Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax) []
- Correlation between MSHQ and IPSS []
- Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
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Patients with an I-PSS total score ≥ 8
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Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation
Exclusion Criteria:
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Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
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Patients who had a previous prostate surgery
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Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
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Patients with a prostate surgery or minimally invasive procedure during the whole study period
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Patients with an active urinary tract infection or prostatitis
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Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
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Patients with a diagnosed prostate cancer
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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
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Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
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Patients with a history of postural hypotension or syncope
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Handok | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Handok Inc.
Investigators
- Study Director: Hyou-Young Rhim, Dr., Handok Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALFUS_L_01778