Randomized Controlled Trial for Efficacy of Botulinum Toxin Type A in Treatment of Patients Suffering Bladder Pain Syndrome/Interstitial Cystitis With Hunners' Lesions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change from baseline in pain intensity
Study Overview
Brief Summary
The etiology of bladder pain syndrome is unknown. Therefore the management is directed to pain relief, as bladder pain is believed to drive both voiding frequency and nocturia. Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy of botox for treatment of painful bladder.
The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are suffering bladder pain syndrome with Hunner lesions during cystoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy
Exclusion Criteria
- •Pregnancy
- •neurologic diseases
- •urinary tract infections
- •bladder outlet obstruction
- •previous pelvic radiotherapy
Outcomes
Primary Outcomes
Change from baseline in pain intensity
Time Frame: 1 week followed by 1, 3, and 6 months after BoNTA injection
Pain intensity is scored using a 10-point visual analog scale and change from baseline is observed
Change from baseline of intensity of bladder bother symptoms
Time Frame: within 1 week, at 3 months and 6 months
O'Leary-Sant score was used to assess symptoms and problems.
Change from baseline of quality of life
Time Frame: within 1 week, at 3 months and 6 months
Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score.
Secondary Outcomes
- Postvoid residual urine volume(within 1 week, at 3months and 6 months after BoNTA injection)
- Upper urinary tract retention(1 week, 3 months and 6 months after BoNTA injection)
Investigators
George Kasyan
Assistant Professor
Moscow State University of Medicine and Dentistry