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

Randomized Controlled Trial for Efficacy of Botulinum Toxin Type A in Treatment of Patients Suffering Bladder Pain Syndrome/Interstitial Cystitis With Hunners' Lesions

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01437579

Enrollment

Registered

2011-09-21

Start date

2011-06-30

Completion date

2012-06-30

Last updated

2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis

Keywords

interstitial cystitis, bladder pain syndrome, intratrigonal injection, botulinum toxin

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.

Interventions

PROCEDUREintratrigonal injection of botulinum toxin

Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia

PROCEDUREcystoscopy

cystoscopy under general anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in pain intensity	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	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	within 1 week, at 3 months and 6 months	Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score.

Secondary

Measure	Time frame	Description
Postvoid residual urine volume	within 1 week, at 3months and 6 months after BoNTA injection	uroflowmetry with residual urine measurement
Upper urinary tract retention	1 week, 3 months and 6 months after BoNTA injection	Kidney ultrasound investigation

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026