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

Moscow State University of Medicine and Dentistry

Status and phase: Unknown; Phase 2

Conditions: Interstitial Cystitis

Treatments: Procedure: intratrigonal injection of botulinum toxin; Procedure: cystoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01437579

BPS/IC Bot1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Botulinum toxin

Active Comparator group

Description:

Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia

Treatment:

Procedure: intratrigonal injection of botulinum toxin

cystoscopy with hydrodistension

Sham Comparator group

Description:

cystoscopy with hydrodistension under general anesthesia

Treatment:

Procedure: cystoscopy