Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms
מילות מפתח
תַקצִיר
תיאור
After complete transurethral resection of primary high risk non-muscle invasive bladder tumors (stage pTa, pT1, carcinoma in situ and high grade urothelial carcinoma), patients on induction course of intravesical BCG with lower urinary tract symptoms unresponsive to standard therapies are enrolled. The patients supply written informed consent to a document describing the investigational nature of the protocol.
Induction treatment consists of an initial 6 intravesical BCG treatments at weekly interval commencing approximately 3 weeks after transurethral resection procedures. The BCG instillation consisted of 81 mg wet weight (10•2±9•0 x 108 colony-forming units) BCG Connaught substrain. Lyophilised (ie, freeze-dried) BCG is suspended in 50 mL bacteriostatic-free solution of 0•9% sodium chloride. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 120 min, followed by emptying of the bladder and removal of the catheter.
During BCG treatment patients with persistent lower urinary tract symptoms unresponsive to standard therapies (anticholinergics, alpha-blockers, antibiotics, analgesics and anti-inflammatory drugs) are treated with an intravesical instillation of 50 ml sterile Baobab natural oil (Baotrophic, Physion Srl, Mirandola, Italy). After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter.
Lower urinary tract symptoms are self-recorded by the patients before and after each baobab oil instillation and classified by the investigator according to a classification grid considering account duration and intensity. The classification of symptoms is class 0= none, class I = mild, class II = moderate, and class III = severe, according to severity. Local adverse events are cystitis, nocturia, pollakiuria, micturition urgency, micturition burning, stress urinary incontinence, dysuria, hematuria, pelvic pain, and perineal pain. The outcome measures are analyzed before and every day for one week after treatment. All patients are assessed for safety.
תאריכים
| אומת לאחרונה: | 08/31/2013 |
| הוגש לראשונה: | 09/01/2013 |
| ההרשמה המשוערת הוגשה: | 09/04/2013 |
| פורסם לראשונה: | 09/10/2013 |
| העדכון האחרון הוגש: | 09/04/2013 |
| עדכון אחרון פורסם: | 09/10/2013 |
| תאריך תחילת לימוד בפועל: | 12/31/2011 |
| תאריך סיום משוער משוער: | 05/31/2013 |
| תאריך סיום משוער ללימודים: | 05/31/2013 |
מצב או מחלה
התערבות / טיפול
Device: Intravesical baobab oil
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| Experimental: Intravesical baobab oil Intravesical instillation of 50 ml sterile Baobab natural oil. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 60 min, followed by emptying of the bladder and removal of the catheter. | Device: Intravesical baobab oil Intravesical baobab oil |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 18 Years ל 18 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | 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. |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Quantitative symptom score questionnaire [36 months]
אמצעי תוצאה משניים
1. Baobab oil toxicity [36 months]
