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The etiology of bladder pain syndrome is unknown. Therefore the management is directed to pain relief, as bladder pain is believed to drive both voiding frequency and nocturia. Botulinum toxin A has been shown to decrease noxious input. Several studies showed efficacy of botox for treatment of painful bladder.
The aim of this study is to evaluate the efficacy of Botulinum toxin in patients who are suffering bladder pain syndrome with Hunner lesions during cystoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin | Active Comparator | Bladder intratrigonal injection of botulinum toxin (100 units) in 10 injection sites during cystoscopy under general anesthesia |
|
| cystoscopy with hydrodistension | Sham Comparator | cystoscopy with hydrodistension under general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intratrigonal injection of botulinum toxin | Procedure | Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain intensity | Pain intensity is scored using a 10-point visual analog scale and change from baseline is observed | 1 week followed by 1, 3, and 6 months after BoNTA injection |
| Change from baseline of intensity of bladder bother symptoms | O'Leary-Sant score was used to assess symptoms and problems. | within 1 week, at 3 months and 6 months |
| Change from baseline of quality of life | Quality of life (QoL) was evaluated using question 8 of the International Prostate Symptoms Score. | within 1 week, at 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postvoid residual urine volume | uroflowmetry with residual urine measurement | within 1 week, at 3months and 6 months after BoNTA injection |
| Upper urinary tract retention | Kidney ultrasound investigation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology department of moscow state university of medicine and dentistry | Recruiting | Moscow | 127206 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734597 | Derived | Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2. |
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| cystoscopy | Procedure | cystoscopy under general anesthesia |
|
| 1 week, 3 months and 6 months after BoNTA injection |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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