Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions
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|ClinicalTrials.gov Identifier: NCT01437579|
Recruitment Status : Unknown
Verified September 2011 by George Kasyan, Moscow State University of Medicine and Dentistry.
Recruitment status was: Recruiting
First Posted : September 21, 2011
Last Update Posted : September 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis||Procedure: intratrigonal injection of botulinum toxin Procedure: cystoscopy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||June 2012|
Active Comparator: Botulinum toxin
Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia
Procedure: intratrigonal injection of botulinum toxin
Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia
Sham Comparator: cystoscopy with hydrodistension
cystoscopy with hydrodistension under general anesthesia
cystoscopy under general anesthesia
- 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.
- Postvoid residual urine volume [ Time Frame: within 1 week, at 3months and 6 months after BoNTA injection ]uroflowmetry with residual urine measurement
- Upper urinary tract retention [ Time Frame: 1 week, 3 months and 6 months after BoNTA injection ]Kidney ultrasound investigation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437579
|Urology department of moscow state university of medicine and dentistry||Recruiting|
|Moscow, Russian Federation, 127206|
|Contact: Konstantin Kolontarev, PhD firstname.lastname@example.org|