The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorJSC NextGen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
The presence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Neovasculgen®
DrugThe 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.
Placebo
DrugThe 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: The investigational therapy group (Neovasculgen)Experimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
within 1 year from treatment start to study endSponsors and contacts
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Source ClinicalTrials.gov