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New treatment option for IC
Official title The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner's Lesions
ClinicalTrials.gov ID: NCT07459790
What this study is testing
What is Neovasculgen®?
Neovasculgen® is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for ic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- 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...
- The presence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
- A glycated hemoglobin level within the normal range for the patient's age group.
You likely can't join if
- 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.
- Pregnant women, planning to become pregnant during the study, or currently breastfeeding.
- Any other conditions associated with pelvic pain, except for PBS.
See the full eligibility criteria
- 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...
- The presence of Hunner's lesions of the bladder during cystoscopy with hydrobougienage of the bladder (2 minutes, 80 cm H2O).
- A glycated hemoglobin level within the normal range for the patient's age group.
- Ability to comply with all study requirements, in the opinion of the investigator, including regularly keeping a voiding diary, completing questionnaires, and attending all scheduled study visits.
- Women who are of childbearing potential must have negative pregnancy test results and must use reliable contraception throughout their participation in the study.
- 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.
- Pregnant women, planning to become pregnant during the study, or currently breastfeeding.
- Any other conditions associated with pelvic pain, except for PBS.
- Pelvic surgery less than 6 months prior to the study.
- Any intravesical procedures, except for diagnostic cystoscopy, less than 3 months prior to screening.
- History of allergy or intolerance to the anesthetic or antibiotics that the investigator intends to use during the study.
- Inability to discontinue anticoagulant/antiplatelet medications at least 5 days prior to each investigational drug administration and resume them on the 4th day after each investigational drug administration (low...
- Diseases of the urinary tract/bladder (neoplasms, tuberculous and bacterial cystitis, urolithiasis, radiation injury, urethral diverticulum, neurogenic dysfunction of the lower urinary tract) and female genital organs...
- Other conditions that, in the opinion of the research physician, could become an objective obstacle to the patient's participation in the study and/or create additional risks for the patient.
- A history of intravesical botulinum therapy performed within the last 12 months prior to inclusion in this study.
- Bladder capacity under anesthesia less than 150 ml.
- Residual urine volume greater than 50 ml.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.