GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis (GETSBI Study)

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Aug 24, 2022

Keywords

ClinConnect Summary

The GETSBI Study is a clinical trial designed to test a treatment called GAG therapy for people suffering from Bladder Pain Syndrome, specifically those with a type known as Hunner lesion subtype (BPS-IC H+). This trial aims to find out if GAG therapy, which involves instilling a substance into the bladder, can effectively reduce pain and improve quality of life for patients compared to a placebo (a treatment without active medication). Researchers are particularly interested in both the short-term and long-term benefits of this therapy.

To participate in the study, you need to be an adult aged 18 or older who has been diagnosed with BPS and has had Hunner lesions identified through a special examination called urethrocystoscopy within the last three months. Additionally, your pain level should be at least 4 on a scale of 0 to 10. However, certain conditions may disqualify you, such as having other causes of bladder pain or recent bladder infections. If you join the trial, you will receive either GAG therapy or a placebo, and researchers will monitor your symptoms over time to see how well the treatment works. This trial is currently recruiting participants, so it could be a valuable opportunity to explore a potential new treatment option for your condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients (18 yrs or older) with symptomatic BPS with established Hunner lesions objectified with urethrocystoscopy in the 3 months prior to inclusion.
• • 2. A VAS pain score (maximum pain during the last 3 days; scale 0-10) of at least 4.
• Exclusion Criteria:
• • 1. pain, discomfort in pelvic region of inflammatory bladder conditions due to any cause other than BPS with Hunner lesions, with the exception of irritable bowel syndrome (IBS) and hypertonic pelvic floor or urine tract infections (UTI; \<3 UTI's / year). This is noted by ESSIC as a confusable disease \[van de Merwe 2007, contains an elaborate table for this\].
• • 2. had a urine tract infection in the previous 6 weeks.
• • 3. received bladder instillations for BPS in the previous 3 months;
• • 4. received intradetrusor Botulinum toxin (BOTOX) injections within the previous 12 months.
• • 5. received transurethral coagulation/ablation therapy of Hunner lesions within the last 12 months, with the exception of patients who have objectified Hunner lesion recurrence(s) on cystoscopy after coagulation/ablation therapy after at least 3 months' post-intervention.
• • 6. started a new treatment for (chronic) pain (pharmacotherapy) or urine tract infection in the last month.
• • 7. Unable (also legal) to give informed consent.
• • 8. Allergic to Hypromellose (tested in one eye)