NCT01437579

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

6 months

First QC Date

September 18, 2011

Last Update Submit

September 20, 2011

Conditions

Interstitial Cystitis

Keywords

interstitial cystitisbladder pain syndromeintratrigonal injectionbotulinum toxin

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in pain intensity

    Pain intensity is scored using a 10-point visual analog scale and change from baseline is observed

    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.

    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.

    within 1 week, at 3 months and 6 months

Secondary Outcomes (2)

  • Postvoid residual urine volume

    within 1 week, at 3months and 6 months after BoNTA injection

  • Upper urinary tract retention

    1 week, 3 months and 6 months after BoNTA injection

Study Arms (2)

Botulinum toxin

ACTIVE COMPARATOR

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

SHAM COMPARATOR

cystoscopy with hydrodistension under general anesthesia

Procedure: cystoscopy

Interventions

intratrigonal injection of botulinum toxinPROCEDURE

Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia

Botulinum toxin
cystoscopyPROCEDURE

cystoscopy under general anesthesia

cystoscopy with hydrodistension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • longer than 6 months of bladder pain syndrome/interstitial cystitis with Hunner Lesion(s) during cystoscopy

You may not qualify if:

  • Pregnancy
  • neurologic diseases
  • urinary tract infections
  • bladder outlet obstruction
  • previous pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department of moscow state university of medicine and dentistry

Moscow, 127206, Russia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32734597DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 18, 2011

First Posted

September 21, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations

RU(1)