Back to resultsEfficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions
Primary Purpose
Interstitial Cystitis
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
intratrigonal injection of botulinum toxin
cystoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring interstitial cystitis, bladder pain syndrome, intratrigonal injection, botulinum toxin
Eligibility 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
Sites / Locations
- Urology department of moscow state university of medicine and dentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Botulinum toxin
cystoscopy with hydrodistension
Arm Description
Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia
cystoscopy with hydrodistension under general anesthesia
Outcomes
Primary Outcome Measures
Change from baseline in pain intensity
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
O'Leary-Sant score was used to assess symptoms and problems.
Change from baseline of quality of life
Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score.
Secondary Outcome Measures
Postvoid residual urine volume
uroflowmetry with residual urine measurement
Upper urinary tract retention
Kidney ultrasound investigation
Full Information
NCT ID
NCT01437579
First Posted
September 18, 2011
Last Updated
September 20, 2011
Sponsor
Moscow State University of Medicine and Dentistry
1. Study Identification
Unique Protocol Identification Number
NCT01437579
Brief Title
Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Moscow State University of Medicine and Dentistry
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
interstitial cystitis, bladder pain syndrome, intratrigonal injection, botulinum toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin
Arm Type
Active Comparator
Arm Description
Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia
Arm Title
cystoscopy with hydrodistension
Arm Type
Sham Comparator
Arm Description
cystoscopy with hydrodistension under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
intratrigonal injection of botulinum toxin
Intervention Description
Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
cystoscopy
Intervention Description
cystoscopy under general anesthesia
Primary Outcome Measure Information:
Title
Change from baseline in pain intensity
Description
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
Title
Change from baseline of intensity of bladder bother symptoms
Description
O'Leary-Sant score was used to assess symptoms and problems.
Time Frame
within 1 week, at 3 months and 6 months
Title
Change from baseline of quality of life
Description
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
Secondary Outcome Measure Information:
Title
Postvoid residual urine volume
Description
uroflowmetry with residual urine measurement
Time Frame
within 1 week, at 3months and 6 months after BoNTA injection
Title
Upper urinary tract retention
Description
Kidney ultrasound investigation
Time Frame
1 week, 3 months and 6 months after BoNTA injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Urology department of moscow state university of medicine and dentistry
City
Moscow
ZIP/Postal Code
127206
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantin Kolontarev, PhD
Email
kb80@yandex.ru
12. IPD Sharing Statement
Citations:
PubMed Identifier
32734597
Citation
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Results Reference
derived
Learn more about this trial
Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions
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