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Patients with Interstitial Cystitis / PBS will be treated with bladder thermal distention (BTD).
In this study we will evaluate the efficacy of bladder thermal distention (BTD) in patients with IC/PBS.
Patients with previous failed conventional treatment (intravesical DMSO) will be recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Thermal Distention (BTD) | Experimental | Continuous irrigation of the bladder with warm saline (up to 45 Celsius) using the PelvixTT system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder Thermal Distention | Procedure | Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| o'leary sant questionnaire | o'leary sant questionnaire is a validated specific tool for evaluation of IC/PBS symptoms | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder diary | symptoms like urgency. frequency and functional voided volumes will be monitored | up to 1 year |
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Inclusion Criteria:
-All patients with interstitial cystitis / painful bladder syndrome (IC/PBS) who had previous intravesical treatment with DMSO
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kobi Stav, MD | Contact | 972-8-9779409 | stavkobi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kobi Stav, MD | Assaf Harofe Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe Medical Center | Recruiting | Ẕerifin | 70300 | Israel |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |