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To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The investigational therapy group | 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-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder. |
| Measure | Description | Time Frame |
|---|---|---|
| "Number of Participants with Treatment-Related effect according to the protocol through study completion, on average, over 1 year. | Until the end of the study |
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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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| Placebo | Drug | The bladder is hydro-bougienaged, followed by intradetrusor injections using a cystoscopic injection needle inserted into a rigid or flexible cystoscope inserted through the urethra into the bladder, under direct visualization. The drug is administered as 30 injections, evenly throughout the bladder. |
|
| 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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