Different Injection Site Maps & Intravesical Botulinum Toxin

Başakşehir Çam & Sakura City Hospital

Status: Begins enrollment this month

Conditions: Bladder Disease

Treatments: Other: Intravesical Botulinum Toxin

Study type: Interventional

Funder types: Other

Identifiers

NCT06185218

KAEK/08.11.2023.530

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• younger than 18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

MAP 1 (Posterior wall only)

Active Comparator group

Description:

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.

Treatment:

Other: Intravesical Botulinum Toxin

MAP 2 (Posterior wall + bilateral side walls)

Active Comparator group

Description:

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.

Treatment:

Other: Intravesical Botulinum Toxin

MAP 3 (Non-trigonal all walls)

Active Comparator group

Description:

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.

Treatment:

Other: Intravesical Botulinum Toxin