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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03076762
Other study ID # BuddhistTCGH2003-01
Secondary ID
Status Recruiting
Phase Phase 2
First received March 1, 2017
Last updated April 6, 2017
Start date March 2015
Est. completion date August 2017

Study information

Verified date April 2017
Source Buddhist Tzu Chi General Hospital
Contact Hann-Chorng HC Kuo, M.D.
Phone 886-3-8561825
Email hck@tzuchi.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is no consensus of the therapeutic efficacy and safety between suburothelial injection and trigonal injection of botulinum toxin A (BoNT-A) in treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) It is unmet to clarify which injection method is superior in clinical efficacy and patient safety. This study was designed in a randomized, double-blind trial to test the therapeutic effects and adverse events between intravesical BoNTA injection into suburothelium and trigone. The results of this study might provide clinical evidence for a better therapeutic regimen of BoNT-A in the treatment of IC/PBS.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
intravesical onabotulinumtoxinA injection
Each vial of onabotulinumtoxinA will be diluted with 10 ml of normal saline, resulting in 10U onabotulinumtoxinA per 1.0 ml. Patients assigned for suburothelial BoNT-A injections received 20 injections in the bladder body whereas those assigned trigonal injections will receive 10 sites injections at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone).

Locations

Country Name City State
Taiwan Buddhist Tzu Chi General Hospital Hualien

Sponsors (1)

Lead Sponsor Collaborator
Buddhist Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of bladder pain visual analog scale (VAS) Evaluation of the change of VAS from baseline to 8 weeks baseline to 8 weeks
Secondary Interstitial cystitis symptom index (ICSI) Evaluation of the change of ICSI froim baseline to 8 weeks baseline to 8 weeks
Secondary Functional bladder capacity The change of maximal bladder capacity in voiding diary from baseline to 8 weeks baseline to 8 weeks
Secondary Maximum flow rate (Qmax) The change of Qmax from baseline to 8 weeks baseline to 8 weeks
Secondary Voided volume Thde change of voided volume from baseline to 8 weeks baseline to 8 weeks
Secondary Postvoid residual volume The change of postvoid residual volume from baseline to 8 weeks baseline to 8 weeks
Secondary Interstitial cystitis problem index (ICPI) Evaluation of the change of ICPI from baseline to 8 weeks baseline to 8 weeks
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