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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Collaborators: Hualien Tzu Chi General Hospital; Ministry of Science and Technology, Taiwan
• Treatments: Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

1. Adults with age of 20 years old or above

2. Patients with symptoms of frequency, urgency, and bladder pain at full bladder for more than 6 months.

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

4. Free of active urinary tract infection

5. Free of bladder outlet obstruction on enrolment

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

7. Patient or his/her legally acceptable representative agrees to sign the written informed consent form

Exclusion Criteria:

1. Patient's lower urinary tract symptoms can be effectively treated by conventional therapy

2. Patient or his/her legally acceptable representative cannot sign the written informed consent form

3. Patient cannot complete the consecutive 3- day voiding diary on the visiting day

4. Patient had been treated for overactive bladder by enterocystoplasty

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

6. Patient has bladder outlet obstruction on enrollment

7. Patients has post-void residual >250ml

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

9. 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

10. Patient has coagulation disorder

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

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

13. Patient had received intravesical hyaluronic acid insillation treatment for IC within recent 6 months before enrolment

14. Patient had received intravesical onabotulinumtoxinA treatment for IC within recent 12 months before enrolment

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