GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis (GETSBI Study) (GETSBI)
Bladder Pain Syndrome
About this trial
This is an interventional treatment trial for Bladder Pain Syndrome focused on measuring Bladder Pain Syndrome, GAG therapy, Hunner lesion, RCT, N-of-1 trial
Eligibility Criteria
Inclusion Criteria:
- Adult patients (18 yrs or older) with symptomatic BPS with established Hunner lesions objectified with urethrocystoscopy in the 3 months prior to inclusion.
- A VAS pain score (maximum pain during the last 3 days; scale 0-10) of at least 4.
Exclusion Criteria:
- 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].
- had a urine tract infection in the previous 6 weeks.
- received bladder instillations for BPS in the previous 3 months;
- received intradetrusor Botulinum toxin (BOTOX) injections within the previous 12 months.
- 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.
- started a new treatment for (chronic) pain (pharmacotherapy) or urine tract infection in the last month.
- Unable (also legal) to give informed consent.
- Allergic to Hypromellose (tested in one eye)
Sites / Locations
- Radboud Unviversity Nijmegen Medical CentreRecruiting
- RijnstateRecruiting
- Andros ClinicsRecruiting
- Slingeland
- Catharina ziekenhuisRecruiting
- Alrijne ziekenhuisRecruiting
- MUMC+Recruiting
- Isala kliniekenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Placebo - Intervention - Intervention
Intervention - Placebo - Intervention
Intervention - Intervention - Placebo
Treatment period 1: placebo for 1x/week for 6 weeks, followed by two treatment periods of 6 weeks receiving GAG-therapy (Ialuril) 1x/week. Finally this arm continues with unblinded GAG-therapy (Ialuril) instillations 1x/month for 6 instillations.
Treatment period 1: GAG-therapy (Ialuril) for 1x/week for 6 weeks, followed by treatment period 2: Placebo for 1x/week for 6 weeks and afterwards treatment period 3: GAG-therapy (Ialuril) for 1/x week for 6 weeks. Finally, this arm continues with unblinded GAG-therapy (Ialuril) instillations 1x/month for 6 instillations.
Treatment period 1: GAG-therapy (Ialuril) for 1x/week for 6 weeks, followed by treatment period 2: GAG-therapy (Ialuril) for 1x/week for 6 weeks and afterwards treatment period 3: placebo for 1/x week for 6 weeks. Finally, this arm continues with unblinded GAG-therapy (Ialuril) instillations 1x/month for 6 instillations.