| May 14, 2008 |
| July 5, 2009 |
| June 2008 |
| December 2009 (final data collection date for primary outcome measure) |
| Actual change in the score of IPSS from baseline to 8 weeks of treatment. [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00679315 on ClinicalTrials.gov Archive Site |
- IPSS parameters [ Time Frame: 4 and 8 weeks of treatment. ] [ Designated as safety issue: No ]
- BFLUTS-SF parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
- Uroflowmetry & PVR parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
- Micturition diary parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
- Quality of life parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
- Patient Perception of Bladder Condition [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
- Benefit, Satisfaction, and Willingness to Continue (BSW) Questions [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
|
| IPSS parameters [ Time Frame: 4 and 8 weeks of treatment. ] [ Designated as safety issue: No ] |
| |
| Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female |
| Efficacy and Safety of Alfuzosin for the Treatment of Non-Neurogenic Voiding Dysfunction in Female: An 8 Week Prospective, Randomized Double Blind, Placebo-Controlled, Parallel Group Study (Phase Ⅱ) |
The purpose of this study is to explore the efficacy of Alfuzosin (10 mg, qd) in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 8 weeks of treatment in female patients with voiding dysfunction. |
Trial design
Phase II, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the clinical efficacy and safety of alfuzosin (10mg, qd) from baseline to 8 weeks of treatment in female patients with non-neurogenic voiding dysfunction.
Efficacy Assessment
Primary efficacy endpoint
Actual change in the score of IPSS from baseline to 8 weeks of treatment.
Secondary efficacy endpoint
|
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Female Voiding Dysfunction |
- Drug: alfuzosin hydrochloride XL 10mg
- Drug: Placebo
|
- Experimental: alfuzosin hydrochloride XL 10mg
- Placebo Comparator: Placebo
|
| |
| |
| Recruiting |
| 280 |
| December 2009 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Female aged ≥ 18
- Have voiding symptoms as chief complaints over 3 months
- IPSS symptom score ≥ 15
- A peak flow rate <12 mL/sec with a minimum voided volume of 100 mL and/or a postvoid residual urine volume >150 mL
- Underwent pressure-flow study
Exclusion Criteria:
- Patients who meet any of the following criteria are to be excluded from the study:
- Neurogenic voiding dysfunction
- Anatomic causes of bladder outlet obstruction
- Perform physical examination in patients diagnosed as BOO in pressure-flow study by urethral evaluation with 16 Fr urethral sound: if there is resistance to 16Fr sound, it will be diagnosed as anatomical BOO and the patients can not participate in the study.
- Previous surgical procedures related to incontinence or cystocele
- Pregnant or nursing women
- Intake of medications and drugs affecting bladder function: alpha blocker, anticholinergic
- Anticholinergic drugs: Tolterodine, Oxybutynin, Propiverin, Trospium, Solifenacin, SSRI including TCA
- Cholinergic drug: Bethanechol
- Any other blocker other than alfuzosin
- patients can be enrolled after wash-out
- Any positive urine culture had to be successfully treated before the recruitment.
- Clinically significant ( ≥ Stamey grade II/III) stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test.
- Recurrent UTIs defined as having been treated for symptomatic UTIs ≥ 4 times in the last year
- Diagnosed or suspected interstitial cystitis
- Patients with marked cystocele or other clinically significant pelvic prolapse.
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with:
- Estrogen treatment started more than 2 months prior to inclusion will be allowed
- Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study.
- Hypersensitive to the study drug
- Orthotopic hypotension or history of orthotopic hypotension
- Intake of calcium channel blockers
- Severe hepatic or renal dysfunctions
|
| Female |
| 18 Years and older |
| No |
|
|
| Korea, Republic of |
| |
| NCT00679315 |
| Kyu-Sung Lee/Professor, Samsung Medical Center |
| 2007-07-073 |
| Samsung Medical Center |
- Handok Pharmaceuticals Co., Ltd.
- The Korean Urological Association
|
| Principal Investigator: |
Kyu-Sung Lee, Ph.D |
Samsung Medical Center |
|
|
| Samsung Medical Center |
| June 2009 |