GAG-therapy Efficacy Trial Solution for Bladder pain syndrome/ Interstitial cystitis

Phase 4

Recruiting

Conditions: 10004994
Bladder pain
urinary frequency

Registration Number: NL-OMON54024

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

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, 2) 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 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) Allergy/Sensibilisation for
artificial tears (this will be tested by applying one drop in one eye).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameter: change from baseline in VAS pain score (3d average<br /><br>and maximal pain score). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters:<br /><br>- Change from baseline in VAS score (0-10) on self-reported secondary symptoms<br /><br>- Change from baseline from self-reported Global Assessment of Improvement<br /><br>(Likert scale)<br /><br>- Change from baseline from O*Leary-Sant IC Symptom Index & Problem Index<br /><br>questionnaire<br /><br>- Change from baseline in urethrocystoscopical evaluation of bladder mucosa<br /><br>(inflammation, active Hunner lesions) (clinician assessed estimated % of<br /><br>inflammation & degree of inflammation)<br /><br>- Change from baseline in Quality of Life using ED-5D 5L questionnaire (Dutch)<br /><br>- Cost effectiveness analyses using iMCQ and iPCQ questionnaires<br /><br>- Changes in Patient Reported Outcome questionnaire (incl. urinary frequency)<br /><br>- Adverse events using Clavien-Dindo system</p><br>