Different Injection Site Maps & Intravesical Botulinum Toxin

Study Overview
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Brief Summary
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Botulinum toxin injection into the bladder is used in current practice in urological diseases such as overactive bladder or interstitial cystitis. As far as is known, botulinum toxin injection sites have not been clearly defined. In this study, investigators are planning to compare botulinum toxin effectiveness with different injection site maps.

Official Title
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The Effect of Different Injection Site Maps on Intravesical Botulinum Toxin of Bladder

Conditions
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Bladder Disease

Intervention / Treatment
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* Other: Intravesical Botulinum Toxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years Interstitial cystitis patients Overactive bladder Exclusion Criteria: younger than 18 years

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: MAP 1 (Posterior wall only)<br>Type 1 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal only posterior wall of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied. | Other: Intravesical Botulinum Toxin<br>* Botulinum Toxin injections will be made into the bladder.<br>|
| Active Comparator: MAP 2 (Posterior wall + bilateral side walls)<br>Type 2 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal posterior wall + bilateral side walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied. | Other: Intravesical Botulinum Toxin<br>* Botulinum Toxin injections will be made into the bladder.<br>|
| Active Comparator: MAP 3 (Non-trigonal all walls)<br>Type 3 map injection will be used to bladder in one session In this arm, Botulinum toxin type A injection will be apply to non-trigonal all walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied. | Other: Intravesical Botulinum Toxin<br>* Botulinum Toxin injections will be made into the bladder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder-V8 questionnaire will be used for efficacy of treatment. | The questionnaire contains 8 questions and every question may be scored between 0 and 5. Additionally, male gender get 2 points more. Therefore, a patient may be get between 0 and 42 points. More score means worse complaint. | Estimated 1 month for every patient after treatment. | 
| Urodynamics test will be assessed for efficacy of treatment. | Possible bladder contractions and residual volume will be measured in urodynamic testing to demonstrate effectiveness after treatment. The lack of pathological bladder contractions and normal residual urine mean better for patient and, show improving. | Estimated 1 month for every patient after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxin, overactive bladder, interstitial cystitis