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Not yet recruitingNCT06185218Updated Aug 15, 2024

Different Injection Site Maps & Intravesical Botulinum Toxin

An interventional study of Intravesical Botulinum Toxin in Bladder Disease, sponsored by Başakşehir Çam & Sakura City Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Başakşehir Çam & Sakura City Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bladder Disease

Keywords

  • Botulinum Toxin
  • overactive bladder
  • interstitial cystitis
03

In context

Urinary Bladder Diseases

62 studies on the registry are indexed under Urinary Bladder Diseases; 9 are open to participants now.

This study's planned enrollment of 60 is below the median of 79 across 42 interventional studies indexed under Urinary Bladder Diseases.

Browse Urinary Bladder Diseases studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • younger than 18 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    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.

    Other: Intravesical Botulinum Toxin

  • Active comparator
    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.

    Other: Intravesical Botulinum Toxin

  • Active comparator
    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.

    Other: Intravesical Botulinum Toxin

Interventions

  • OtherIntravesical Botulinum Toxin

    Botulinum Toxin injections will be made into the bladder.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Estimated 1 month for every patient after treatment.

  2. 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.

    Time frame: Estimated 1 month for every patient after treatment.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06185218
Responsible party
Sponsor
First posted
Dec 29, 2023
Start date
Oct 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Aug 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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