GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Rationale: Efficacy study (RCT) for glycosaminoglycan(GAG)-therapy for the indication bladder pain syndrome / interstitial cystitis with Hunner lesion subtype (BPS-IC H+). reason for this study is a current lack of evidence regarding its efficacy and cost-effectiveness. Main objective is to determine short and long term efficacy of GAG therapy (bladder instillations) for people with BPS-IC H+ as compared to placebo treatment on dominant symptoms such as pain and Quality of Life (QOL)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Netherlands
Rijnstate
RECRUITING
Arnhem
Andros Clinics
RECRUITING
Baarn
Slingeland
NOT_YET_RECRUITING
Doetinchem
Catharina ziekenhuis
RECRUITING
Eindhoven
Alrijne ziekenhuis
RECRUITING
Leiden
MUMC+
RECRUITING
Maastricht
Radboud Unviversity Nijmegen Medical Centre
RECRUITING
Nijmegen
Isala klinieken
RECRUITING
Zwolle
Contact Information
Primary
D.A.W. Janssen, MD PhD
dick.janssen@radboudumc.nl
+31641856516
Backup
Charlotte van Ginkel, MD
charlotte.jvanginkel@radboudumc.nl
Time Frame
Start Date: 2021-10-21
Estimated Completion Date: 2024-10-21
Participants
Target number of participants: 80
Treatments
Experimental: Placebo - Intervention - Intervention
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.
Experimental: Intervention - Placebo - Intervention
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.
Experimental: Intervention - Intervention - Placebo
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.
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center
Collaborators: IQ Healthcare, Radboud Technology Ceter, Zorginstituut Nederland, ZonMw: The Netherlands Organisation for Health Research and Development