Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms
Condition: Superficial Bladder Cancer; Lower Urinary Tract Symptoms
MeSH terms: Urinary Bladder Neoplasms; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Intravesical baobab oil
Intervention type(s): Device
Intervention description(s): Intravesical baobab oil
Other intervention name(s): Baotrophic, Physion Srl, Mirandola, Italy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High risk non-muscle invasive urothelial bladder cancer; Intravesical BCG; Local toxicity; Natural baobab oil