Bladder Disease Clinical Trial
Official title:
The Effect of Different Injection Site Maps on Intravesical Botulinum Toxin of Bladder
| Verified date | February 2024 |
| Source | Basaksehir Cam & Sakura Sehir Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | October 2024 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Older than 18 years - Interstitial cystitis patients - Overactive bladder Exclusion Criteria: - younger than 18 years |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Basaksehir Cam & Sakura Sehir Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |
| Primary | 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. |
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