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To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis with Hunner's lesions to reduce cicatricial changes in the bladder caused by electrocoagulation and to prevent secondary bladder shrinkage with a decrease in its volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The investigational therapy group (Neovasculgen) | Experimental | Receiving combination therapy: coagulation of Hunner's lesions of the bladder followed by hydrobougienage and intradetrusor administration of Neovasculgen |
|
| Placebo group | Placebo Comparator | Control group, receiving basic therapy: coagulation of Hunner's lesions of the bladder followed by hydrobougienage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neovasculgen® | Drug | The bladder is hydro-bougienated, Hunner's lesions are identified, and electrocoagulation is performed using a resectoscope using standard techniques, followed by repeated hydro-bougienage of the bladder. The drug/placebo is then administered using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder. The drug/placebo is injected evenly along the edges of the coagulated area and into the Hunner's lesion itself, and then evenly along the bladder walls in a series of 30 injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced a treatment effect at study end, within 1 year from treatment start to study end. | Conclusions about the effectiveness of treatment will be made based on the results of cystoscopies, patient complaints and questionnaire results. | within 1 year from treatment start to study end |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botkin Hospital | Recruiting | Moscow | Russia |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Placebo | Drug | The bladder is hydro-bougienated, Hunner's lesions are identified, and electrocoagulation is performed using a resectoscope using standard techniques, followed by repeated hydro-bougienage of the bladder. The drug/placebo is then administered using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder. The drug/placebo is injected evenly along the edges of the coagulated area and into the Hunner's lesion itself, and then evenly along the bladder walls in a series of 30 injections. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |