Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

1. Adults with age of 20 years old or above

2. Patients with symptoms of frequency, urgency, nocturia, and/or bladder pain.

3. Proven to have glomerulations (at least grade 2) by cystoscopic hydrodistention under anesthesia in recent 1 year

4. Free of active urinary tract infection

5. Free of bladder outlet obstruction on enrollment

6. Free of overt neurogenic bladder dysfunction and limitation of ambulation

7. Patient or his/her legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

1. Hunner's lesion proven by cystoscopy

2. Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up

3. Patients with bladder outlet obstruction on enrollment

4. Patients with postvoid residual >250ml

5. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection

6. Patients have laboratory abnormalities at screening including: ALT> 3 x upper limit of normal range, AST> 3 x upper limit of normal range; Patients have abnormal serum creatinine level > 2 x upper limit of normal range

7. Patients with any contraindication to be urethral catheterization during treatment

8. Female patients who is pregnant, lactating, or with child-bearing potential without contraception.

9. Myasthenia gravis, Eaton Lambert syndrome.

10. Patients with any other serious disease considered by the investigator not in the condition to enter the trial

11. Patient had received intravesical treatment for IC within recent 1 month

12. Patients participated investigational drug trial within 1 month before entering this study