Evaluation of Symptom-specific Goal Achievement (NCT00836823) | Clinical Trial Compass
CompletedPhase 4
Evaluation of Symptom-specific Goal Achievement
South Korea130 participantsStarted 2005-12
Plain-language summary
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) consists of a constellation of symptoms (including voiding, storage, and post-micturition). The impact of the LUTS on patients' health-related quality of life is substantial and multifaceted. Thus, the therapies aimed at treating BPH are concerned primarily with improving patients' symptoms, thereby improving quality of life. When multiple symptoms are present, the level of bother associated with individual symptoms varies and patients prioritize their treatment goals for symptom relief. A measure that addresses patients' most bothersome symptoms (MBS) and evaluation of symptom-specific goal achievements may lead to improved outcomes and patient satisfaction to the treatment. The objectives of this study were (1) to assess patient-reported MBS and symptom-specific goal achievements (PGA) with medical treatment in BPH patients, and (2) to identify factors that influence or have relation to the PGA.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* males ≥50 years with LUTS secondary to BPH
* Moderate to severe LUTS : IPSS ≥ 8
* An enlarged prostate : TRUS ≥25 mL
* Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL)
* Having signed the informed consent to participate in the study.
Exclusion Criteria:
* Post voided residual urine ≥ 200mL
* Patients performing catheterization
* Urinary tract infection patients
* Patients taking 5 alpha reductase inhibitor
* Known hypersensitivity to alfuzosin
* History of postural hypotension or syncope
* Hypertension patients treated with other alpha1-blockers
* Patients newly taking anticholinergic medication within 1 month
* Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
* Renal insufficiency (s-Cr ≥ 2mg/dL)
* Unstable angina pectoris
* Uninvestigated hematuria
* Serum PSA ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
* Interstitial cystitis patients
* Severe concomitant condition threatening life.
* Patient who is unable to make voiding diary
* Bladder or prostate cancer patients
* Patients receiving prostate or bladder surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-reported goal achievements for the most bothersome symptoms