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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02247557
• Date of registration: 15/09/2014
• Prospective Registration: No
• Primary sponsor: Buddhist Tzu Chi General Hospital
• Public title: Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis
• Scientific title: Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis — a Randomized, Double-blind, Placebo-controlled, Prospective Study
• Date of first enrolment: September 2014
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02247557
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Hann-Chorng Kuo, M.D.
• Affiliation: Department of Urology, Buddihisst Tzu Chi General Hospital and Tzu Chi University

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Intervention(s)

Drug: Liposome encapsulated BoNT-A

Drug: BOTOX 200U in normal saline

Drug: Normal saline

Primary Outcome(s)

Change of the O'Leary-Sant symptom score [Time Frame: Baseline and 1 month]

Secondary Outcome(s)

Net Change of the urinary nerve growth factor [Time Frame: Baseline and 1 month]

Net Change of the PVR [Time Frame: Baseline and 1 month]

Net Change of the maximum flow rate [Time Frame: Baseline and 1 month]

Net changes of the voiding frequency at night time as recorded in 3-day voiding diary [Time Frame: Baseline and 1 month]

Net Change of the cytokines level [Time Frame: Baseline and 1 month]

Net changes of the Visual Analog Scale (VAS) [Time Frame: Baseline and 1 month]

Net Change of the voided volume [Time Frame: Baseline and 1 month]

Net Change of the Global response assessment (GRA) [Time Frame: Baseline and 1 month]

Net changes of the functional bladder capacity (FBC) [Time Frame: Baseline and 1 month]

Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary [Time Frame: Baseline and 1 month]

Secondary ID(s)

TCGHUROL011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors