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

Interstitial Cystitis Clinical Trial

Official title:

Randomized Controlled Trial for Efficacy of Botulinum Toxin Type A in Treatment of Patients Suffering Bladder Pain Syndrome/Interstitial Cystitis With Hunners' Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01437579
• Other study ID #: BPS/IC Bot1
• Status: Recruiting
• Phase: Phase 2
• First received: September 18, 2011
• Last updated: September 20, 2011
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2011
• Source: Moscow State University of Medicine and Dentistry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Procedure:
• intratrigonal injection of botulinum toxin
Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia
• cystoscopy
cystoscopy under general anesthesia

Locations

Country	Name	City	State
Russian Federation	Urology department of moscow state university of medicine and dentistry	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain intensity	Pain intensity is scored using a 10-point visual analog scale and change from baseline is observed	1 week followed by 1, 3, and 6 months after BoNTA injection	No
Primary	Change from baseline of intensity of bladder bother symptoms	O'Leary-Sant score was used to assess symptoms and problems.	within 1 week, at 3 months and 6 months	No
Primary	Change from baseline of quality of life	Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score.	within 1 week, at 3 months and 6 months	No
Secondary	Postvoid residual urine volume	uroflowmetry with residual urine measurement	within 1 week, at 3months and 6 months after BoNTA injection	Yes
Secondary	Upper urinary tract retention	Kidney ultrasound investigation	1 week, 3 months and 6 months after BoNTA injection	Yes