Efficacy and Safety of Low Energy Shock Wave Plus BotulinumToxin A in Treating Patients With Interstitial Cystitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-18

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02247557

Interstitial Cystitis

COMPLETED PHASE2

Delivery of Intravesical Botulinum Toxin A Using Low Energy Shock Waves in Treatment of Overactive Bladder: A Feasibility Study

NCT03385460

Overactive Bladder Botulinum Toxin Intravesical +1 more

UNKNOWN NA

Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility

NCT02135341

Botulinum Toxins, Type A

COMPLETED PHASE2

Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial Cystitis

NCT03076762

Bladder Pain Syndrome

UNKNOWN PHASE2

Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome

NCT01167257

Overactive Bladder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Interstitial cystitis/ bladder pain syndrome (IC/BPS) is a bladder disorder with unknown etiology and difficult treatment. Novel treatments have been searched to adequately improved symptoms. Low energy shock wave (LESW) increased urothelial permeability, facilitated intravesical botulinum toxin A (BoNT-A) delivery and blocked acetic acid induced hyperactive bladder. Rats that received BoNT-A plus LESW showed a significantly reduced response (48.6% decreased intercontractile interval) to acetic acid instillation without compromising voiding function. Rats pre-treated with BoNT-A plus LESW showed a decreased inflammatory reaction (p \<0.05), and decreased expressions of SNAP-23 (p \< 0.05), SNAP-25 (p = 0.061) and COX-2 (p \< 0.05) compared with the control group. These results support LESW as a promising method to deliver BoNT-A across urothelium without the need for injection. LESW is known to facilitate tissue regeneration with analgesic and anti-inflammatory effects. LESW treatment reduced pain behavior and down-regulated the NGF expression (33.3%, P \< 0.05) on day 4 and IL-6 (40.9%, P \< 0.05). LESW treatment suppressed bladder overactivity (intercontractile interval 77.8% increase, P \< 0.05) by decreasing inflammation and COX2 (38.6%, P \< 0.05) expression and NGF expression (25.2%, P = 0.0812). Previous study revealed that LESW might be a potential candidate for relieving bladder inflammatory conditions and overactivity. Recent clinical trial also revealed that Intravesical instillation of BoNT-A and LESW is a safe and effective method for the treatment of refractory overactive bladder with a durable response for 2 months. A double-blind, randomized, placebo-controlled physician-initiated study enrolled 54 patients with IC/BPS. The patients were assigned to LESW or placebo. At 4 weeks post-treatment, both groups were associated with a statistically significant decrease in OSS and VAS pain scale. A significantly higher proportion of patients on LESW responded as improved in the VAS ≥ 3 vs placebo (P = 0.035). At 12 weeks post-treatment, improvement in the VAS ≥ 3 was 57.1% vs 19.0% (LESW vs placebo; P = 0.011). No significant adverse events were found in either group. This study aims to investigate the therapeutic efficacy and safety of concomitant LESW plus intravesical BoNT-A instillation for IC/BPS patients refractory to conventional treatments.

Materials and Methods

Eligible participants of either gender with IC/BPS refractory to at least two treatments will be enrolled to this study. Participants are randomly allocated to receive either treatment in 1:1 ratio according to the permuted block randomization code as the following:

(A) LESW treatment with 3000 shocks, and followed by intravesical instillation of 30ml normal saline. (placebo group)

(B) LESW with 3000 shocks, and followed by intravesical BoNT-A 100U instillation. (treatment group)

Urine samples will be collected for urinary protein and biomarkers analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interstitial Cystitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double-blind, randomized, placebo-controlled physician initiated study enrolled patients with refractory IC/BPS.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participants and investigator are blinded to the treatment arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group : BoNT-A 100 U in Normal saline

BOTOX 100U in normal saline (BoNT-A/NS) 30ml in single intravesical instillation

Group Type EXPERIMENTAL

BOTOX 100U in normal saline

Intervention Type DRUG

LESW with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical BoNT-A 100U instillation in 30ml normal saline retained in the bladder for 2 hours, every one week for 4 times.

Placebo group : Normal saline

Normal saline (N/S) 30ml in single intravesical instillation

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

LESW treatment with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical instillation of 30ml normal saline retained in the bladder for 2 hours after LESW application, every one week for 4 times.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BOTOX 100U in normal saline

LESW with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical BoNT-A 100U instillation in 30ml normal saline retained in the bladder for 2 hours, every one week for 4 times.

Intervention Type DRUG

Normal saline

LESW treatment with 3000 shocks, frequency of 3 pulses per second, and maximum total energy flow density 0.25 mJ/mm2 , and followed by intravesical instillation of 30ml normal saline retained in the bladder for 2 hours after LESW application, every one week for 4 times.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BOTOX Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No