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

NCT05518864 | Recruiting Phase 4 DMC

• 1 other identifier: 110130
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

Brief 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)

Conditions

Bladder Pain Syndrome

Keywords

Bladder Pain Syndrome; GAG therapy; Hunner lesion; RCT; N-of-1 trial

Outcome Measures

Primary Outcomes (1)

• Change in maximum bladder pain

  VAS pain score (0-10; 0= no pain, 10=worst pain)

  Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54

Secondary Outcomes (12)

• Change in average bladder pain

  Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54

• 7-point Global Response Assessment (GRA) scale

  Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54

• Change in patient assessed most dominant symptom

  Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54

• Voiding urgency

  Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54

• Voiding frequency

  Fase 1: Week 1,2,5,7,8,12,15,17,18,22,25,27,28,29 Fase 2:week 32, 36, 40, 44, 48, 54

Study Arms (3)

Placebo - Intervention - Intervention

EXPERIMENTAL

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.

Device: IALURIL Prefill

Intervention - Placebo - Intervention

EXPERIMENTAL

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.

Device: IALURIL Prefill

Intervention - Intervention - Placebo

EXPERIMENTAL

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.

Device: IALURIL Prefill

Interventions

IALURIL Prefill DEVICE

GAG therapy (bladder instillations with glycosaminoglycans)

Intervention - Intervention - Placebo; Intervention - Placebo - Intervention; Placebo - Intervention - Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A VAS pain score (maximum pain during the last 3 days; scale 0-10) of at least 4.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• IQ Healthcare: collaborator
• Radboud Technology Ceter: collaborator
• Zorginstituut Nederland: collaborator

Study Sites (8)

Radboud Unviversity Nijmegen Medical Centre

Nijmegen, Gelderland, 6500, Netherlands

RECRUITING

Rijnstate

Arnhem, 6815AD, Netherlands

RECRUITING

Andros Clinics

Baarn, 3741GP, Netherlands

RECRUITING

Slingeland

Doetinchem, 7009 BL, Netherlands

NOT YET RECRUITING

Catharina ziekenhuis

Eindhoven, 5623 EJ, Netherlands

RECRUITING

Alrijne ziekenhuis

Leiden, 2334 CK, Netherlands

RECRUITING

MUMC+

Maastricht, 6229HX, Netherlands

RECRUITING

Isala klinieken

Zwolle, 8025 AB, Netherlands

RECRUITING

Related Publications (2)

• van Ginkel C, Groenewoud JMM, Hoogeboom TJ, Heesakkers J, Martens F, Janssen D. Carry-over effects in GAG therapy efficacy trial solution for bladder pain syndrome/interstitial cystitis (GETSBI study): an interim analysis. BMJ Open. 2025 Jun 5;15(6):e092757. doi: 10.1136/bmjopen-2024-092757.

  PMID: 40473282 DERIVED

• van Ginkel C, Baars C, Heesakkers J, Martens F, Janssen D. Study protocol of a multicentre double-blind RCT, comparing a traditional RCT with an aggregated N-of-1 trial: GAG therapy Efficacy Trial Solution for Bladder pain syndrome/Interstitial cystitis (GETSBI study). BMJ Open. 2023 Apr 12;13(4):e068546. doi: 10.1136/bmjopen-2022-068546.

  PMID: 37045569 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

D.A.W. Janssen, MD PhD

CONTACT

+31641856516; dick.janssen@radboudumc.nl

Charlotte van Ginkel, MD

CONTACT

charlotte.jvanginkel@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blinded by care provider (person giving the treatment) and the participant (blinded syringes en placebo product)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study start as a normal double blinded RCT, but continues with an aggregated N-of-1 (multi-crossover) type trial

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: August 29, 2022
• Study Start: October 21, 2021
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (8)