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

Study Overview
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Brief Summary
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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.

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

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Procedure: intratrigonal injection of botulinum toxin
* Procedure: cystoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin<br>Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia | Procedure: intratrigonal injection of botulinum toxin<br>* Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia<br>|
| Sham Comparator: cystoscopy with hydrodistension<br>cystoscopy with hydrodistension under general anesthesia | Procedure: cystoscopy<br>* cystoscopy under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interstitial cystitis, bladder pain syndrome, intratrigonal injection, botulinum toxin