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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Moscow State University of Medicine and Dentistry.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
George Kasyan, Moscow State University of Medicine and Dentistry
ClinicalTrials.gov Identifier:
NCT01437579
First received: September 18, 2011
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Interstitial Cystitis
Procedure: intratrigonal injection of botulinum toxin
Procedure: cystoscopy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Moscow State University of Medicine and Dentistry:

Primary Outcome Measures:
  • Change from baseline in pain intensity [ Time Frame: 1 week followed by 1, 3, and 6 months after BoNTA injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score.


Secondary Outcome Measures:
  • Postvoid residual urine volume [ Time Frame: within 1 week, at 3months and 6 months after BoNTA injection ] [ Designated as safety issue: Yes ]
    uroflowmetry with residual urine measurement

  • Upper urinary tract retention [ Time Frame: 1 week, 3 months and 6 months after BoNTA injection ] [ Designated as safety issue: Yes ]
    Kidney ultrasound investigation


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: cystoscopy
cystoscopy under general anesthesia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437579

Locations
Russian Federation
Urology department of moscow state university of medicine and dentistry Recruiting
Moscow, Russian Federation, 127206
Contact: Konstantin Kolontarev, PhD       kb80@yandex.ru   
Sponsors and Collaborators
Moscow State University of Medicine and Dentistry
  More Information

No publications provided

Responsible Party: George Kasyan, Assistant Professor, Moscow State University of Medicine and Dentistry
ClinicalTrials.gov Identifier: NCT01437579     History of Changes
Other Study ID Numbers: BPS/IC Bot1
Study First Received: September 18, 2011
Last Updated: September 20, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Moscow State University of Medicine and Dentistry:
interstitial cystitis
bladder pain syndrome
intratrigonal injection
botulinum toxin

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014