Efficacy and Safety of Low Energy Shock Wave Plus BotulinumToxin A in Treating Patients With Interstitial Cystitis
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and
anti-inflammatory effects. LESW treatment has been demonstrated effective in treatment of
nonbacterial prostatitis and chronic pelvic pain syndrome. LESW reduced pain behavior and
down-regulated the NGF expression, suppressed bladder overactivity by decreasing
inflammation, IL-6 and COX2 expression and NGF expression. Previous rat interstitial cystitis
(IC) models have shown LESW could increase urothelial permeability, facilitate intravesical
botulinum toxin A (BoNT-A) delivery and block acetic acid induced hyperactive bladder,
suggesting LESW might be a potential therapeutic candidate for relieving bladder inflammatory
conditions and overactivity. A double-blind, randomized, placebo-controlled
physician-initiated study revealed LESW treatment was associated with a statistically
significant decrease in O'Leary-Saint Symptom Score and visual analog scale of pain in
patients with interstitial cystitis/bladder pain syndrome (IC/BPS), but the improvement was
not superior to the sham LESW treatment. Previous studies found the urothelial dysfunction
and deficits of cell differentiation are fundamental pathophysiology of IC/BPS. Through
intravesical platelet-rich plasma injections, the chronic inflammation in IC/BPS bladders
could be reduced and improved cell differentiation of urothelium. Botox injection or liposome
encapsulated Botox could also inhibit inflammation and improve IC/BPS symptoms. However, the
Botox injection needs anesthesia and certain complications might occur. There is no study to
test if LESW plus Botox intravesical instillation could improve bladder inflammation and
relieve IC/BPS symptoms. This study aims to investigate the therapeutic efficacy and safety
of concomitant LESW plus intravesical BoNT-A instillation for IC/BPS refractory to
conventional treatments.
Phase:
Phase 2
Details
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Collaborators:
Hualien Tzu Chi General Hospital Ministry of Science and Technology, Taiwan