Voiding DysfunctionPhase 2NCT00679315
Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female
A Phase 2 study testing alfuzosin hydrochloride XL 10mg in people with Voiding Dysfunction, run by Samsung Medical Center at 9 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Voiding Dysfunction
- What is being tested?
- alfuzosin hydrochloride XL 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Jun 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Chungnam National University Hospital
Daejeon
Holy Family Hospital, The Catholic University of Korea
Kyonggi-do, 420-717
Pusan National University Hospital
Pusan, 602-739
Samsung Medical Center
Seoul, Seoul, 135-710
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
Seoul, 100-380
Seoul National University Hospital
Seoul, 110-744
Anam Hospital, College of Medicine, Korea University
Seoul, 136-705
Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, 137-701
Asan Medical Center, Ulsan College of Medicine
Seoul, 138-736
About this study
Official title: 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.
Read the detailed description
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
- IPSS parameters
- Percent change in the score of IPSS from baseline to 4 and 8 weeks of treatment.
- Actual and percent changes in the sub-scale of IPSS from baseline to 4 and 8 weeks of treatment
- Storage score: sum of questions 2, 4 and 7
- Voiding score: sum of questions 1, 3, 5 and 6
- Scored form of the Bristol Female Lower Urinary Tract Symptoms (BFLUTS-SF)parameters
- Actual and Percent change in BFLUTS-SF from baseline to 4 and 8 weeks of treatment.
- Actual and percent changes in the sub-scale of BFLUTS-SF from baseline to 4 and 8 weeks of treatment
- BFLUTS-FS: sum scores F1-F4
- BFLUTS-VS: sum scores V1-V3
- BFLUTS-IS: sum scores I1-I5
- BFLUTS-sex: sum scores S1 \& S2
- Uroflowmetry \& PVR parameters
- Numeric and percent changes from baseline to 4 and 8 weeks of treatment.
- Maximum flow rate (mL/s)
- Average flow rate (mL/s)
- Post-void residual urine (mL)
- Micturition diary parameters
- Change in mean number of micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Percent change of micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Change in mean number of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Percent change of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Change in mean number of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating of ≥ 3 in the diary).
- Percent change of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline
- Change in the mean and sum rating on the Bladder Sensation Scale at weeks 4 and 8 relative to baseline
- Quality of life (QoL) parameters
- Change in Bother score of IPSS from baseline to 4 and 8 weeks of treatment.
- Change in QOL subscale scores of BFLUTS SF from baseline to 4 and 8 weeks of treatment
- BFLUTS-QoL: Sum scores QoL1-QoL5
- Patient Perception of Bladder Condition (PPBC)
- Change from baseline in PPBC after 8 weeks of double-blind treatment
- Benefit, Satisfaction, and Willingness to Continue (BSW) Questions
- Patient Perception of Treatment Benefit at week 8
- Patient Perception of Treatment Satisfaction at week 8
- Willingness to continue with treatment at week 8
- Conditions
- Voiding Dysfunction
- Being tested
- alfuzosin hydrochloride XL 10mg, Placebo
- Keywords
- female voiding dysfunction, alpha adrenoreceptor antagonists, IPSS or American Urological Association symptom index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfuzosin hydrochloride XL 10mgDrug
Also called Xatral® XL
One tablet to be taken daily after a meal before bedtime for 8 weeks.
PlaceboDrug
One tablet to be taken daily after a meal before bedtime for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alpha blocker | Experimental | alfuzosin hydrochloride XL 10mg Receives: Drug: alfuzosin hydrochloride XL 10mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual change in the score of IPSS from baseline to 8 weeks of treatment.
Measured: 8 weeks of treatment
Secondary outcomes (7)
IPSS parameters
Measured: 4 and 8 weeks of treatment.
BFLUTS-SF parameters
Measured: 4 and 8 weeks of treatment
Uroflowmetry & PVR parameters
Measured: 4 and 8 weeks of treatment
Micturition diary parameters
Measured: 4 and 8 weeks of treatment
Quality of life parameters
Measured: 4 and 8 weeks of treatment
Patient Perception of Bladder Condition
Measured: 8 weeks of treatment
Benefit, Satisfaction, and Willingness to Continue (BSW) Questions
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Handok Inc., The Korean Urological Association
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679315
- Sponsor's protocol ID
- 2007-07-073
- Status last verified
- Jun 2013
- First submitted
- 14 May 2008
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00679315
- Acronym / sponsor ID
- 2007-07-073
- Conditions
- Voiding Dysfunction
- Keywords
- female voiding dysfunction, alpha adrenoreceptor antagonists, IPSS or American Urological Association symptom index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Handok Inc., The Korean Urological Association
- Study start
- Jun 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- IPSS parameters
- Percent change in the score of IPSS from baseline to 4 and 8 weeks of treatment.
- Actual and percent changes in the sub-scale of IPSS from baseline to 4 and 8 weeks of treatment
- Storage score: sum of questions 2, 4 and 7
- Voiding score: sum of questions 1, 3, 5 and 6
- Scored form of the Bristol Female Lower Urinary Tract Symptoms (BFLUTS-SF)parameters
- Actual and Percent change in BFLUTS-SF from baseline to 4 and 8 weeks of treatment.
- Actual and percent changes in the sub-scale of BFLUTS-SF from baseline to 4 and 8 weeks of treatment
- BFLUTS-FS: sum scores F1-F4
- BFLUTS-VS: sum scores V1-V3
- BFLUTS-IS: sum scores I1-I5
- BFLUTS-sex: sum scores S1 \& S2
- Uroflowmetry \& PVR parameters
- Numeric and percent changes from baseline to 4 and 8 weeks of treatment.
- Maximum flow rate (mL/s)
- Average flow rate (mL/s)
- Post-void residual urine (mL)
- Micturition diary parameters
- Change in mean number of micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Percent change of micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Change in mean number of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Percent change of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline
- Change in mean number of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating of ≥ 3 in the diary).
- Percent change of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline
- Change in the mean and sum rating on the Bladder Sensation Scale at weeks 4 and 8 relative to baseline
- Quality of life (QoL) parameters
- Change in Bother score of IPSS from baseline to 4 and 8 weeks of treatment.
- Change in QOL subscale scores of BFLUTS SF from baseline to 4 and 8 weeks of treatment
- BFLUTS-QoL: Sum scores QoL1-QoL5
- Patient Perception of Bladder Condition (PPBC)
- Change from baseline in PPBC after 8 weeks of double-blind treatment
- Benefit, Satisfaction, and Willingness to Continue (BSW) Questions
- Patient Perception of Treatment Benefit at week 8
- Patient Perception of Treatment Satisfaction at week 8
- Willingness to continue with treatment at week 8
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha blocker | Experimental | Drug: alfuzosin hydrochloride XL 10mgalfuzosin hydrochloride XL 10mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alfuzosin hydrochloride XL 10mgAlso: Xatral® XLOne tablet to be taken daily after a meal before bedtime for 8 weeks. | Drug | Alpha blocker |
| PlaceboOne tablet to be taken daily after a meal before bedtime for 8 weeks. | Drug | Placebo |
Primary outcome
Actual change in the score of IPSS from baseline to 8 weeks of treatment.
Time frame: 8 weeks of treatment
7 secondary outcomes
IPSS parameters
Time frame: 4 and 8 weeks of treatment.
BFLUTS-SF parameters
Time frame: 4 and 8 weeks of treatment
Uroflowmetry & PVR parameters
Time frame: 4 and 8 weeks of treatment
Micturition diary parameters
Time frame: 4 and 8 weeks of treatment
Quality of life parameters
Time frame: 4 and 8 weeks of treatment
Patient Perception of Bladder Condition
Time frame: 8 weeks of treatment
Benefit, Satisfaction, and Willingness to Continue (BSW) Questions
Time frame: 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alfuzosin hydrochloride XL 10mg in people with Voiding Dysfunction, run by Samsung Medical Center at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual change in the score of IPSS from baseline to 8 weeks of treatment. (time frame: 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013.