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In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention (BTD) in patients with overactive bladder syndrome who failed previous treatment of anticholinergic drugs.
The investigators' hypothesis is that it will improve the storage symptoms.
Inclusion criteria:
Exclusion criteria:
Outcome measures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Thermal Distention | Experimental | Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using a specific 3 ways catheter. The procedure will last 1 hour. Saline will be irrigated by the PelvixTT system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder Thermal Distention | Procedure | Bladder Thermal Distention is an approved procedure in Europe from 2006. The treatment is hydrodistention of the bladder with a warm saline (up to 45C). The procedure lasts 1 hour. The saline is infused constantly through a 3 ways specific catheter (Unithermia 18F) by the PelvixTT system. |
| Measure | Description | Time Frame |
|---|---|---|
| Urgency Questionnaire | Patients will complete the validated USIQ questionnaire | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Daily frequency of micturitions on Bladder Diary | Patients will complete bladder diaries before and after the procedure. Frequencies of micturitions per day will be documented | up to 1 year |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kobi Stav, MD | Contact | 972-8-9778461 | stavkobi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kobi Stav, MD | Assaf Harofe MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe MC | Recruiting | Tel Aviv Region | Zeriffin | 70300 | Israel |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |