Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms
キーワード
概要
説明
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.
日付
| 最終確認済み: | 08/31/2013 |
| 最初に提出された: | 09/01/2013 |
| 提出された推定登録数: | 09/04/2013 |
| 最初の投稿: | 09/10/2013 |
| 最終更新が送信されました: | 09/04/2013 |
| 最終更新日: | 09/10/2013 |
| 実際の研究開始日: | 12/31/2011 |
| 一次完了予定日: | 05/31/2013 |
| 研究完了予定日: | 05/31/2013 |
状態または病気
介入/治療
Device: Intravesical baobab oil
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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 |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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. |
結果
主な結果の測定
1. Quantitative symptom score questionnaire [36 months]
二次的な結果の測定
1. Baobab oil toxicity [36 months]
