null - FindTrial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023293-39-SE

Enrollment

150

Registered

2010-10-11

Start date

2010-11-26

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

Interventions

Trade Name: Medicinsk Oxygen Product Name: Medicinsk Oxygen Product Code: Medicinsk Oxygen Pharmaceutical Form: Inhalation gas INN or Proposed INN: Medicinsk Oxygen CAS Number: 7782-44-7 Current Spons

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Main Inclusion criteria: Radiation cystitis with at least one of the symptoms listed below: Haematuria, Dysuria, Urgency, Nocturia (>1/night), Frequent urination (>6/days), Urinary incontinence Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Main Inclusion criteria: -Patients with major and ongoing bleedings from the bladder -Contraindications for HBO therapy -Pregnancy -Untreated pneumothorax -Mechanical ventilator support -Not oriented to person, place and time

Design outcomes

Primary

Measure	Time frame
Main Objective: Can hyperbaric oxygen treatment reverse symptomes from radiation induced cystitis?;Secondary Objective: Secondary objectives are: (1) Does HBO treatment improve QoL measured by SF-36. (2) does HBO reverse negative changes or otherwise limit the damage seen after radiation in the pelvic region as part of cancer treatment measured with immunohistochemical analysis of biopsies taken from the urinary bladder during cystoscipy. ;Primary end point(s): Primary endpoint is reduction in symptoms measured with EPIC.	—

Measure

Time frame

Main Objective: Can hyperbaric oxygen treatment reverse symptomes from radiation induced cystitis?;Secondary Objective: Secondary objectives are: (1) Does HBO treatment improve QoL measured by SF-36. (2) does HBO reverse negative changes or otherwise limit the damage seen after radiation in the pelvic region as part of cancer treatment measured with immunohistochemical analysis of biopsies taken from the urinary bladder during cystoscipy. ;Primary end point(s): Primary endpoint is reduction in symptoms measured with EPIC.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026