Different Injection Site Maps & Intravesical Botulinum Toxin

NCT ID: NCT06185218

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-10-31

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.

Detailed Description

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Conditions

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Bladder Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MAP 1 (Posterior wall only)

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.

Group Type ACTIVE_COMPARATOR

Intravesical Botulinum Toxin

Intervention Type OTHER

Botulinum Toxin injections will be made into the bladder.

MAP 2 (Posterior wall + bilateral side walls)

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.

Group Type ACTIVE_COMPARATOR

Intravesical Botulinum Toxin

Intervention Type OTHER

Botulinum Toxin injections will be made into the bladder.

MAP 3 (Non-trigonal all walls)

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.

Group Type ACTIVE_COMPARATOR

Intravesical Botulinum Toxin

Intervention Type OTHER

Botulinum Toxin injections will be made into the bladder.

Interventions

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Intravesical Botulinum Toxin

Botulinum Toxin injections will be made into the bladder.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years
* Interstitial cystitis patients
* Overactive bladder

Exclusion Criteria

* younger than 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KAEK/08.11.2023.530

Identifier Type: -

Identifier Source: org_study_id

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