Bladder Pain SyndromePhase 4GETSBINCT05518864
GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis (GETSBI Study)
A Phase 4 study testing IALURIL Prefill in people with Bladder Pain Syndrome, run by Radboud University Medical Center at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Pain Syndrome
- What is being tested?
- IALURIL Prefill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesNetherlands
- Study dates
- 21 Oct 2021to 21 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
Charlotte van Ginkel, MD contact
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Recruiting
Rijnstate
Arnhem, 6815AD
Michael van Balken, PhD MD, mvanbalken@rijnstate.nl
Michael van Balken, PhD MD
- Recruiting
Andros Clinics
Baarn, 3741GP
Erik Arendsen, MD PhD, e.arendsen@andros.nl
Dick Janssen, d.janssen@andros.nl
- Not yet recruiting
Slingeland
Doetinchem, 7009 BL
Erich Taubert, PhD MD, e.taubert@slingeland.nl
Erich Taubert, PhD MD
- Recruiting
Catharina ziekenhuis
Eindhoven, 5623 EJ
Evert Koldewijn, PhD mD, evert.koldewijn@catharinaziekenhuis.nl
Evert Koldewijn, PhD MD
- Recruiting
Alrijne ziekenhuis
Leiden, 2334 CK
Barbara Schout, PhD MD, bmaschout@alrijne.nl
Barbara Schout, PhD MD
- Recruiting
MUMC+
Maastricht, 6229HX
John Heesakkers, Prof PhD MD, john.heesakkers@mumc.nl
John Heesakkers, Prof PhD MD
- Recruiting
Radboud Unviversity Nijmegen Medical Centre
Nijmegen, Gelderland, 6500
Dick Janssen, MD PhD, 0243610503, dick.janssen@radboudumc.nl
Charlotte van Ginkel, MD, charlotte.jvanginkel@radboudumc.nl
- Recruiting
Isala klinieken
Zwolle, 8025 AB
Bart Witte, PhD MD, i.p.w.witte@isala.nl
Bart Witte, PhD MD
About this study
Official title: GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis
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)
Read the detailed description
Rationale:
Reimbursement in the Netherlands for GAG-therapy for bladder pain syndrome / interstitial cystitis patients with Hunner lesion subtype (BPS-IC H+) is under debate, as evidence regarding its efficacy and cost-effectiveness is lacking.
Objective:
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. Secondary objectives are to determine the 1) cost-effectiveness of GAG therapy, 2) effectiveness of GAG therapy on quality of life and bladder inflammation evaluated by urethrocystoscopy
Study design:
Multi-design study. Study is powered and set-up as double-blinded randomized intervention study and is extended with a double-blinded aggregated N-of-1 trial. As requested by the Zorginstituut Netherlands, the study will be further extended with a prospective, non-blinded intervention study to evaluate long term follow up with a low frequency therapy dose.
Study population:
People with symptomatic BPS-IC H+ (> 18 yrs old). A total of 80 patients will be included for the main study.
Intervention :
GAG bladder instillations (hyaluronic acid + chondroitin sulfate; Ialuril) 50ml administered with a catheter. Placebo will be Hypromellose 50ml administered with a catheter. Patients will receive instillations (Ialuril / placebo with ratio 2:1) in 3 periods of 6 wks with frequency of 1 instillation/wk. With wash-out periods 4 wks. After 3 periods of treatment / placebo (wk 30), blinding will cease and continue unblinded where all subjects will receive maintenance therapy Ialuril for 1x/4wk until 54 weeks (endpoint).
Main study parameters/endpoints:
Primary outcome parameter: change from baseline in maximum bladder pain (visual analogue scale (VAS) pain score (3d average and maximal pain score).
Secondary outcome parameters:
- Change from baseline in VAS score (0-10) on self-reported secondary symptoms
- Change from baseline from self-reported Global Assessment of Improvement (Likert scale)
- Change from baseline from O'Leary-Sant IC Symptom Index \& Problem Index questionnaire
- Change from baseline in urethrocystoscopic evaluation of bladder mucosa (inflammation, active Hunner lesions) (clinician assessed estimated % of inflammation \& degree of inflammation)
- Change from baseline in Quality of Life using ED-5D 5L questionnaire (Dutch)
- Cost effectiveness analyses using iMCQ and iPCQ questionnaires
- Changes in Patient Reported Outcome questionnaire (incl. urinary frequency)
- Adverse events using Clavien-Dindo system
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Benefits patients and group relatedness. All participants are capacitated adults and will receive a similar amount of intervention and placebo treatments. Treatment corresponds to the Dutch NVU guideline BPS. Therapy will be reimbursed for patients. During 54wks, patients will have a 6 week period where placebo is given. Due to the study design, patients can obtain a personal (individual) study efficacy result if therapy was successful in him/her.
Therapy and placebo: risks and burden This study will be submitted as low-intervention trial. GAG therapy (instillations) has been used for >25 yrs in clinical practice to treat BPS-IC. GAG-therapies are registered as medical devices. The therapy is instilled into the bladder using a catheter (by nurse / patient). Catherization has a small increased risk for developing an urine tract infection (1.9%) [Herr 2015], urethral discomfort and in rare cases urethral trauma.
The placebo compound Hypromellose 0.3% is used as moisturizing drops to treat dry eyes. It is inert (non-irritating and hypo-allergenic). Very rare (< 0.01%) side effects are reported in the Dutch 'Farmacologisch Kompas'. They report local side effects of sensitivity (burning, itch, tears e.d.). Blurry vision. and very rare systemic effects as rash, itch.Because of these reported side effects at inclusion the (over)sensitivity is checked by one drop in an eye, taking into account the possible blurry vision afterwards.
- Conditions
- Bladder Pain Syndrome
- Being tested
- IALURIL Prefill
- Keywords
- Bladder Pain Syndrome, GAG therapy, Hunner lesion, RCT, N-of-1 trial
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IALURIL PrefillDevice
GAG therapy (bladder instillations with glycosaminoglycans)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: IALURIL Prefill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum bladder pain
VAS pain score (0-10; 0= no pain, 10=worst pain)
Measured: 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
VAS pain score (0-10; 0= no pain, 10=worst pain)
Measured: 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
The GRA is a 7-point descriptive scale, scores of 1-3 indicate worsening of symptoms, and 5-7 indicate and improvement in symptoms
Measured: 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
VAS score (0-10; 0= no burden, 10=high burden)
Measured: 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
as single item from the validated Genito-Urinary Pain Index questionnaire (5 point Likert scale)
Measured: 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
as single item from the validated Genito-Urinary Pain Index questionnaire (5 point Likert scale)
Measured: 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
O'leary Sant interstitial cystitis symptom index/problem index (ICSI/ICPI)
Validated BPS-IC related symptom questionaire
Measured: week 1, 6, 18, 28, 29, 40, 48
Patient Reported Outcome Measurement (PROM) short and extended
Improvement (0-100%), continue treatment, reccommend to family, including Adverse Events and start/stop other treatment for BPS/IC
Measured: week 1, 8, 18, 28, 29, 40, 48
Voiding diary
2x24h
Measured: at baseline
Quality of Life questionnaire
Outcome of ED-5D 5L QoL questionnaire
Measured: week 1, 6, 18, 28, 29, 40, 48
Urine sediment
Screening for bacterial urinary tract infection
Measured: week 1, 6, 18, 28, 29, 40, 48
Cost effectiveness
iMCQ and iPCQ questionaires
Measured: week 1, 8, 18, 28
Cystoscopic evaluation
Likert scale inflammation (1-5)
Measured: week 8 and week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start21 Oct 2021
- Primary completion21 Oct 2024 (estimated)
- Study completion21 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bladder Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study start as a normal double blinded RCT, but continues with an aggregated N-of-1 (multi-crossover) type trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, IQ Healthcare, Radboud Technology Ceter, Zorginstituut Nederland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518864
- Sponsor's protocol ID
- 110130
- Acronym
- GETSBI
- Status last verified
- Feb 2024
- First submitted
- 21 Dec 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only anonymous patient data will be shared
Publications
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.
PubMed 40473282van 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.
PubMed 37045569
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT05518864
- Acronym / sponsor ID
- GETSBI / 110130
- Conditions
- Bladder Pain Syndrome
- Keywords
- Bladder Pain Syndrome, GAG therapy, Hunner lesion, RCT, N-of-1 trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, IQ Healthcare, Radboud Technology Ceter, Zorginstituut Nederland
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Oct 2024 (estimated)
- Study completion
- 21 Oct 2024 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Rationale:
Reimbursement in the Netherlands for GAG-therapy for bladder pain syndrome / interstitial cystitis patients with Hunner lesion subtype (BPS-IC H+) is under debate, as evidence regarding its efficacy and cost-effectiveness is lacking.
Objective:
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. Secondary objectives are to determine the 1) cost-effectiveness of GAG therapy, 2) effectiveness of GAG therapy on quality of life and bladder inflammation evaluated by urethrocystoscopy
Study design:
Multi-design study. Study is powered and set-up as double-blinded randomized intervention study and is extended with a double-blinded aggregated N-of-1 trial. As requested by the Zorginstituut Netherlands, the study will be further extended with a prospective, non-blinded intervention study to evaluate long term follow up with a low frequency therapy dose.
Study population:
People with symptomatic BPS-IC H+ (> 18 yrs old). A total of 80 patients will be included for the main study.
Intervention :
GAG bladder instillations (hyaluronic acid + chondroitin sulfate; Ialuril) 50ml administered with a catheter. Placebo will be Hypromellose 50ml administered with a catheter. Patients will receive instillations (Ialuril / placebo with ratio 2:1) in 3 periods of 6 wks with frequency of 1 instillation/wk. With wash-out periods 4 wks. After 3 periods of treatment / placebo (wk 30), blinding will cease and continue unblinded where all subjects will receive maintenance therapy Ialuril for 1x/4wk until 54 weeks (endpoint).
Main study parameters/endpoints:
Primary outcome parameter: change from baseline in maximum bladder pain (visual analogue scale (VAS) pain score (3d average and maximal pain score).
Secondary outcome parameters:
- Change from baseline in VAS score (0-10) on self-reported secondary symptoms
- Change from baseline from self-reported Global Assessment of Improvement (Likert scale)
- Change from baseline from O'Leary-Sant IC Symptom Index \& Problem Index questionnaire
- Change from baseline in urethrocystoscopic evaluation of bladder mucosa (inflammation, active Hunner lesions) (clinician assessed estimated % of inflammation \& degree of inflammation)
- Change from baseline in Quality of Life using ED-5D 5L questionnaire (Dutch)
- Cost effectiveness analyses using iMCQ and iPCQ questionnaires
- Changes in Patient Reported Outcome questionnaire (incl. urinary frequency)
- Adverse events using Clavien-Dindo system
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Benefits patients and group relatedness. All participants are capacitated adults and will receive a similar amount of intervention and placebo treatments. Treatment corresponds to the Dutch NVU guideline BPS. Therapy will be reimbursed for patients. During 54wks, patients will have a 6 week period where placebo is given. Due to the study design, patients can obtain a personal (individual) study efficacy result if therapy was successful in him/her.
Therapy and placebo: risks and burden This study will be submitted as low-intervention trial. GAG therapy (instillations) has been used for >25 yrs in clinical practice to treat BPS-IC. GAG-therapies are registered as medical devices. The therapy is instilled into the bladder using a catheter (by nurse / patient). Catherization has a small increased risk for developing an urine tract infection (1.9%) [Herr 2015], urethral discomfort and in rare cases urethral trauma.
The placebo compound Hypromellose 0.3% is used as moisturizing drops to treat dry eyes. It is inert (non-irritating and hypo-allergenic). Very rare (< 0.01%) side effects are reported in the Dutch 'Farmacologisch Kompas'. They report local side effects of sensitivity (burning, itch, tears e.d.). Blurry vision. and very rare systemic effects as rash, itch.Because of these reported side effects at inclusion the (over)sensitivity is checked by one drop in an eye, taking into account the possible blurry vision afterwards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Study start as a normal double blinded RCT, but continues with an aggregated N-of-1 (multi-crossover) type trial
| Arm | Type | Receives |
|---|---|---|
| Placebo - Intervention - Intervention | Experimental | Device: IALURIL PrefillTreatment 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. |
| Intervention - Placebo - Intervention | Experimental | Device: IALURIL PrefillTreatment 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. |
| Intervention - Intervention - Placebo | Experimental | Device: IALURIL PrefillTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IALURIL PrefillGAG therapy (bladder instillations with glycosaminoglycans) | Device | Intervention - Intervention - Placebo, Intervention - Placebo - Intervention, Placebo - Intervention - Intervention |
Primary outcome
Change in maximum bladder pain
Time frame: 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
VAS pain score (0-10; 0= no pain, 10=worst pain)
12 secondary outcomes
Change in average bladder pain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
O'leary Sant interstitial cystitis symptom index/problem index (ICSI/ICPI)
Time frame: week 1, 6, 18, 28, 29, 40, 48
Patient Reported Outcome Measurement (PROM) short and extended
Time frame: week 1, 8, 18, 28, 29, 40, 48
Voiding diary
Time frame: at baseline
Quality of Life questionnaire
Time frame: week 1, 6, 18, 28, 29, 40, 48
Urine sediment
Time frame: week 1, 6, 18, 28, 29, 40, 48
Cost effectiveness
Time frame: week 1, 8, 18, 28
Cystoscopic evaluation
Time frame: week 8 and week 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 40473282van 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.
- Derived from this study: PubMed 37045569van 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.
- Individual participant dataSharing planned: No. only anonymous patient data will be shared
Related trials for Bladder Pain Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte van Ginkel, MD contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IALURIL Prefill in people with Bladder Pain Syndrome, run by Radboud University Medical Center at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact D.A.W. Janssen, MD PhD (+31641856516, dick.janssen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum bladder pain (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.