Different Injection Site Maps & Intravesical Botulinum Toxin

NCT06185218 | Not Yet Recruiting

• 1 other identifier: KAEK/08.11.2023.530
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bladder Disease

Keywords

Botulinum Toxin; overactive bladder; interstitial cystitis

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

MAP 1 (Posterior wall only)

ACTIVE COMPARATOR

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

MAP 2 (Posterior wall + bilateral side walls)

ACTIVE COMPARATOR

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

MAP 3 (Non-trigonal all walls)

ACTIVE COMPARATOR

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

Interventions

Intravesical Botulinum Toxin OTHER

Botulinum Toxin injections will be made into the bladder.

MAP 1 (Posterior wall only); MAP 2 (Posterior wall + bilateral side walls); MAP 3 (Non-trigonal all walls)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• younger than 18 years

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

MeSH Terms

Conditions

Urinary Bladder Diseases; Urinary Bladder, Overactive; Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cystitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 29, 2023
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-02