Interstitial CystitisPhase 2NCT01437579
Efficacy of Botulinum Toxin Type A in Patients With Bladder Pain Syndrome/Intersticial Cystitis and Hunners' Lesions
A Phase 2 study testing intratrigonal injection of botulinum toxin and cystoscopy in people with Interstitial Cystitis, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- intratrigonal injection of botulinum toxin and cystoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy
Who cannot join
- Pregnancy
- neurologic diseases
- urinary tract infections
- bladder outlet obstruction
- previous pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Urology department of moscow state university of medicine and dentistry
Moscow, 127206
Konstantin Kolontarev, PhD, kb80@yandex.ru
About this study
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
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.
- Conditions
- Interstitial Cystitis
- Being tested
- intratrigonal injection of botulinum toxin, cystoscopy
- Keywords
- interstitial cystitis, bladder pain syndrome, intratrigonal injection, botulinum toxin
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intratrigonal injection of botulinum toxinProcedure or surgery
Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia
cystoscopyProcedure or surgery
cystoscopy under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin | Active comparator | Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia Receives: Procedure: intratrigonal injection of botulinum toxin |
| cystoscopy with hydrodistension | Sham comparator | cystoscopy with hydrodistension under general anesthesia Receives: Procedure: cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain intensity
Pain intensity is scored using a 10-point visual analog scale and change from baseline is observed
Measured: 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.
Measured: 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.
Measured: within 1 week, at 3 months and 6 months
Secondary outcomes (2)
Postvoid residual urine volume
uroflowmetry with residual urine measurement
Measured: within 1 week, at 3months and 6 months after BoNTA injection
Upper urinary tract retention
Kidney ultrasound investigation
Measured: 1 week, 3 months and 6 months after BoNTA injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow State University of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Kasyan, Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437579
- Sponsor's protocol ID
- BPS/IC Bot1
- Status last verified
- Sep 2011
- First submitted
- 18 Sep 2011
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32734597
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01437579
- Acronym / sponsor ID
- BPS/IC Bot1
- Conditions
- Interstitial Cystitis
- Keywords
- interstitial cystitis, bladder pain syndrome, intratrigonal injection, botulinum toxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Moscow State University of Medicine and DentistryUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin | Active comparator | Procedure: intratrigonal injection of botulinum toxinBladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia |
| cystoscopy with hydrodistension | Sham comparator | Procedure: cystoscopycystoscopy with hydrodistension under general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy
Key exclusion criteria (5 listed)
- Pregnancy
- neurologic diseases
- urinary tract infections
- bladder outlet obstruction
- previous pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intratrigonal injection of botulinum toxinBladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia | Procedure or surgery | Botulinum toxin |
| cystoscopycystoscopy under general anesthesia | Procedure or surgery | cystoscopy with hydrodistension |
Primary outcome
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.
2 secondary outcomes
Postvoid residual urine volume
Time frame: within 1 week, at 3months and 6 months after BoNTA injection
Upper urinary tract retention
Time frame: 1 week, 3 months and 6 months after BoNTA injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
- Derived from this study: PubMed 32734597Imamura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intratrigonal injection of botulinum toxin and cystoscopy in people with Interstitial Cystitis, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain intensity (time frame: 1 week followed by 1, 3, and 6 months after BoNTA injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01437579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.