GAG therapy for bladder pain syndrome

GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis

This study is testing if a new bladder treatment called GAG therapy can help people with bladder pain syndrome feel less pain and improve their quality of life compared to a placebo.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (other)
• Locations: 8 sites (Nijmegen, Gelderland and 7 other locations)
• Trial ID: NCT05518864 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of glycosaminoglycan (GAG) therapy in treating bladder pain syndrome with Hunner lesions. It is designed as a double-blinded randomized controlled trial comparing GAG bladder instillations to a placebo treatment. The main focus is on assessing pain relief and quality of life improvements over both short and long-term periods. Additionally, the study will analyze the cost-effectiveness of GAG therapy and its impact on bladder inflammation through urethrocystoscopy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic bladder pain syndrome and confirmed Hunner lesions.

Not a fit: Patients with bladder pain due to conditions other than bladder pain syndrome with Hunner lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce pain and improve quality of life for patients suffering from bladder pain syndrome.

How similar studies have performed: Previous studies on GAG therapy have shown promise, but this specific approach is being evaluated for the first time in this context.

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)

Where this trial is running

Nijmegen, Gelderland and 7 other locations

• Radboud Unviversity Nijmegen Medical Centre — Nijmegen, Gelderland, Netherlands (RECRUITING)
• Rijnstate — Arnhem, Netherlands (RECRUITING)
• Andros Clinics — Baarn, Netherlands (RECRUITING)
• Slingeland — Doetinchem, Netherlands (NOT_YET_RECRUITING)
• Catharina ziekenhuis — Eindhoven, Netherlands (RECRUITING)
• Alrijne ziekenhuis — Leiden, Netherlands (RECRUITING)
• MUMC+ — Maastricht, Netherlands (RECRUITING)
• Isala klinieken — Zwolle, Netherlands (RECRUITING)

Study contacts

• Study coordinator: D.A.W. Janssen, MD PhD

Conditions: Bladder Pain Syndrome, GAG therapy, Hunner lesion, RCT, N-of-1 trial