Lower Urinary Tract Symptoms Clinical Trial
— BaobabOfficial title:
Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms: a Phase I-II Study
Verified date | September 2013 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Baobab oil is often used in traditional medicine as antipyretic, antioxidant, anti-inflammatory, analgesic and antimicrobial. It also regenerates the epithelial tissue in a short time improving tone and elasticity. We want to evaluate the effects of intravesical Baobab oil in patients with BCG-induced lower urinary tract symptoms.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Age 18 years or older - Complete transurethral resection of primary histologically proven high risk urothelial non-muscle invasive bladder tumors: high grade (G3,) stage pTa, pT1, and carcinoma in situ (pTis - Intravesical BCG treatment - Adequate bone marrow reserve (ie, white-blood-cell count =4000 x106 cells/L and platelet count =120 x 109/L - Normal renal function (function (ie, serum creatinine =123•76 µmol/L) - normal liver function ((ie, serum glutamic-oxaloacetic transaminase =42 U/L, serum glutamic-pyruvic transaminase =48 U/L, and total bilirubin =22•23 µmol/L) - Karnofsky performance score of 50 to 100 Exclusion Criteria: - Previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs - Previous or concomitant urothelial carcinoma of the upper urinary tract and urethra, or both - Previous muscle-invasive (ie, stage T2 or higher) urothelia carcinoma of the bladder - Known allergy to baobab oil - Bladder capacity less than 200 mL - Untreated urinary-tract infection - Severe systemic infection (ie, sepsis) - Urethral strictures that would prevent endoscopic procedures and catheterisation - Disease of upper urinary tract (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures at risk - Previous radiotherapy to the pelvis; - Other concurrent chemotherapy; - Treatment with radiotherapy-response or biological-response modifiers; - Other malignant diseases within 5 years of trial registration (except for basal-cell carcinoma); - Pregnancy or nursing; - Psychological, familial, sociological, or geographical factors that would preclude study participation. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Savino M. Di Stasi | Rome | |
Italy | Tor Vergata University | Rome |
Lead Sponsor | Collaborator |
---|---|
Savino M. Di Stasi | University of Bari |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative symptom score questionnaire | A quantitative symptom score questionnaire is completed by the patients before treatment to establish baseline symptoms and daily during the following 7 days after treatment. The questionnaire is designed to evaluate 10 lower urinary tract symptoms (cystitis, nocturia, pollakiuria, micturition urgency, micturition burning, stress urinary incontinence, dysuria, hematuria, pelvic pain, and perineal pain. Most symptoms are scored on a 0 to 3-point scale, corresponding to none/mild/moderate/severe. | 36 months | Yes |
Secondary | Baobab oil toxicity | All patients are assessed for safety or allergy to intravesical baobab oil | 36 months | Yes |
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