To evaluate the efficacy and safety of Neovasculgen in interstitial cystitis and the prevention of secondary bladder shrinkage with a decrease in its volume.
Written informed consent prior to any study-related procedures.
Women aged 18 to 65 years, inclusive.
A confirmed diagnosis of painful bladder syndrome/interstitial cystitis, characterized by pelvic pain associated with filling or emptying the bladder, frequent urination day and night, with symptoms lasting at least 12 months, with the exclusion of a urinary tract infection or other disease that could cause such symptoms.
Absence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
Any condition that prevents intravesical administration of medications.
Received medication or non-medication therapy, including physical therapy, for BPS/IC within 1 month prior to study inclusion.
Instillation of any pharmacological agent into the bladder less than 1 month prior to screening.
History of chronic drug or alcohol abuse.
Parallel
Neovasculgen®
DrugThe 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.
Placebo
DrugThe 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.
"Number of Participants with Treatment-Related effect according to the protocol through study completion, on average, over 1 year.
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