ClinicalTrials.Veeva

Menu

Different Injection Site Maps & Intravesical Botulinum Toxin

B

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)

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems