Radiation Induced Cystits treated with Hyperbaric Oxygen. A Randomized controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001381-15-SE

Enrollment

Registered

2012-04-16

Start date

2012-06-13

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Cystitis MedDRA version: 14.1 Level: PT Classification code 10057480 Term: Hyperbaric oxygen therapy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Medicinsk Oxygen Product Name: Medicinsk Oxygen Pharmaceutical Form: Inhalation gas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Provision of informed consent prior to any study specific procedures - Female or male aged 18-80 years - Intended curative radiation of the pelvic region as a treatment for cancer - End of radiation therapy more than 6 months ago - Radiation cystitis with Urological EPIC =65 years) no F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Patients with major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks) - Refractory incontinence requiring catheter or surgical intervention - Urine bladder capacity < 100ml - Fistula in the urine bladder - Contraindications for HBO therapy according to the local centres routines - Pregnancy - Mechanical ventilator support - Unable to follow and understand simple commands - Not oriented to person, place and time

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess the relief of symptoms after HBO therapy in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable;Secondary Objective: •To investigate the mucosa with respect to functionality by assessment of inflammation activity, quantification of fibrosis, vascular density and the presence of stems cells having histological analysis from biopsies as variable •To assess the severity of radiation injury having the RTOG-scale as variable •To assess health-related quality of life before and after HBO therapy having SF-36 as the variable ;Primary end point(s): The primary endoint is symptom rating after HBO therapy using the self-administrated EPIC-questionnaire original score as the primary variable;Timepoint(s) of evaluation of this end point: At baseline and at Visit 4, 6-8 weeks after finalized treatment	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess the relief of symptoms after HBO therapy in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable;Secondary Objective: •To investigate the mucosa with respect to functionality by assessment of inflammation activity, quantification of fibrosis, vascular density and the presence of stems cells having histological analysis from biopsies as variable •To assess the severity of radiation injury having the RTOG-scale as variable •To assess health-related quality of life before and after HBO therapy having SF-36 as the variable ;Primary end point(s): The primary endoint is symptom rating after HBO therapy using the self-administrated EPIC-questionnaire original score as the primary variable;Timepoint(s) of evaluation of this end point: At baseline and at Visit 4, 6-8 weeks after finalized treatment

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Secondary

Measure	Time frame
Secondary end point(s): • Severity of radiation injury having the RTOG as the variable at baseline and visit 4 • Histological analysis of inflammation activity, degree of fibrosis, vascular density and the presence of stems cells at baseline and visit 4. • Health-related quality of life (SF36) at baseline visit 3, 4 and 5 • Post-study long-term follow-up follow up with Symptom rating (EPIC) and Health-related quality of life (SF36);Timepoint(s) of evaluation of this end point: Baseline (visit 1) and 6-8 months (visit 4). SF-36 also immediately after finalized HBOT (visit 3 and 5) Long-term follow-up: 5 years after finalized study	—

Measure

Time frame

Secondary end point(s): • Severity of radiation injury having the RTOG as the variable at baseline and visit 4 • Histological analysis of inflammation activity, degree of fibrosis, vascular density and the presence of stems cells at baseline and visit 4. • Health-related quality of life (SF36) at baseline visit 3, 4 and 5 • Post-study long-term follow-up follow up with Symptom rating (EPIC) and Health-related quality of life (SF36);Timepoint(s) of evaluation of this end point: Baseline (visit 1) and 6-8 months (visit 4). SF-36 also immediately after finalized HBOT (visit 3 and 5) Long-term follow-up: 5 years after finalized study

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Countries

Denmark, Norway, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 1, 2026