None listed
Conditions
Interventions
Drug : 1) Product name (name of active ingredients) and administration
Pentosan-polysulfate sodiumPPS, 100 mg, thrice a day, 1 hour before meals or 2 hours after meals.
2) Efficacy and side effects
E
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Female and male patients over 30 years of age. (2) Patients who complain of symptoms such as suprapubic or pelvic pain with full bladder accompanied by daytime polyuria, nocturia, and urgency, according to the obtained medical history. Of the patients who meet criterion (2) above, those fulfilling the below will be selected: (3) who do not have physical examination findings suggestive of urinary tract infection or urogenital tract tumor, (4) who do not have hematuria or pyuria on urinalysis, (5) who have negative liquid-based urine cytology, and (6) who understand the purposes of the study and are willing to sign the informed consent form. However, the patients must also satisfy one of the following: - The sum of scores for questions 2 (daytime polyuria), 4 (urgency), and 7 (nocturia) on the IPSS questionnaire should be at least 6. - Patients should have at least 8 daytime urinations or at least 1 nocturia or urgency documented on their frequency volume chart.
Exclusion criteria
Exclusion criteria: (1) Patients who have hematuria or pyuria on urinalysis and require additional tests or antibiotic treatment. (2) Patients who have been diagnosed with malignant tumor in the urinary system. (3) Patients who have a history of anomaly or damages in the urinary system. (4) Patients who require urological surgery during the treatment period. (5) Patients who cannot communicate freely. (6) Patients who cannot be followed up for at least 6 months after the beginning of treatment. (7) Patients who are pregnant or breastfeeding (will be screened via a medical examination and interview).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in the sum of scores for questions 2, 4, and 7 on the International Prostate Symptom Score IPSS after 12-week treatment of Pentosan-polysulfate sodium PPS/changes in the frequency of daytime urination and frequency of nocturia documented on the frequency volume chart after 12-week treatment of Pentosan-polysulfate sodium | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in the Overactive Bladder Symptom Score symptom scores after 12-week treatment of Pentosan-polysulfate sodium /changes in the Visual Analog Scale for Pain score with full bladder after 12 weeks of Pentosan-polysulfate sodium /changes in the maximal urination volume, nocturia volume, and nocturia index on the frequency volume chart after 12-week treatment of Pentosan-polysulfate sodium . | — |
Countries
Korea, Republic of
Contacts
Public ContactJI WOEN PARK
Korea University Anam Hospital
Outcome results
None listed