A Phase 2 interventional study of intratrigonal injection of botulinum toxin and cystoscopy in Interstitial Cystitis, sponsored by Moscow State University of Medicine and Dentistry. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-21.
Sponsored by Moscow State University of Medicine and Dentistry · Phase 2, Interventional, and Treatment
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.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →Moscow State University of Medicine and Dentistry is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia
Procedure: intratrigonal injection of botulinum toxin
cystoscopy with hydrodistension under general anesthesia
Procedure: cystoscopy
Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia
cystoscopy under general anesthesia
Change from baseline in pain intensity
Pain intensity is scored using a 10-point visual analog scale and change from baseline is observed
Time frame: 1 week followed by 1, 3, and 6 months after BoNTA injection
Change from baseline of intensity of bladder bother symptoms
O'Leary-Sant score was used to assess symptoms and problems.
Time frame: within 1 week, at 3 months and 6 months
Change from baseline of quality of life
Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score.
Time frame: within 1 week, at 3 months and 6 months
Postvoid residual urine volume
uroflowmetry with residual urine measurement
Time frame: within 1 week, at 3months and 6 months after BoNTA injection
Upper urinary tract retention
Kidney ultrasound investigation
Time frame: 1 week, 3 months and 6 months after BoNTA injection
This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Moscow State University of Medicine and Dentistry