Intravesical Natural Baobab Oil in the Management of BCG-induced Lower Urinary Tract Symptoms

NCT01939756 | Completed Phase 1 DMC

• 1 other identifier: UTV-101-2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Superficial Bladder Cancer; Lower Urinary Tract Symptoms

Keywords

High risk non-muscle invasive urothelial bladder cancer; Intravesical BCG; Local toxicity; Natural baobab oil

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Baobab oil toxicity

  36 months

Study Arms (1)

Intravesical baobab oil

EXPERIMENTAL

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

Interventions

Intravesical baobab oil DEVICE

Intravesical baobab oil

Also known as: Baotrophic, Physion Srl, Mirandola, Italy

Intravesical baobab oil

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Savino M. Di Stasi: lead
• University of Bari: collaborator

Study Sites (2)

Savino M. Di Stasi

Rome, 00133, Italy

Location

Tor Vergata University

Rome, 00133, Italy

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Savino M Di Stasi, MD, PhD

  Tor Vergata University, Rome, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Urology, MD, PhD

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 11, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

IT (2)