Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions

Phase 2

• Conditions: Interstitial Cystitis
• Interventions: Procedure: intratrigonal injection of botulinum toxin; Procedure: cystoscopy

• Registration Number: NCT01437579
• Lead Sponsor: Moscow State University of Medicine and Dentistry

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2011-09
• Study First Submitted: 2011-09-18
• Study First Submitted QC: 2011-09-20
• Last Update Submitted: 2011-09-20
• Study First Posted: 2011-09-21
• Last Update Posted: 2011-09-21
• Primary Completion: 2011-12
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin	intratrigonal injection of botulinum toxin	Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia
cystoscopy with hydrodistension	cystoscopy	cystoscopy with hydrodistension under general anesthesia

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity	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	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	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 Outcome Measures

Name	Time	Method
Postvoid residual urine volume	within 1 week, at 3months and 6 months after BoNTA injection	uroflowmetry with residual urine measurement
Upper urinary tract retention	1 week, 3 months and 6 months after BoNTA injection	Kidney ultrasound investigation

Trial Locations

Locations (1)

Urology department of moscow state university of medicine and dentistry; 🇷🇺 Moscow, Russian Federation