Prevention of Acute Radiation cystitis by using Intra-vesical chondroitin Sulphate.

Phase 3

• Conditions: irradiationlesion of the bladder; 10004994

• Registration Number: NL-OMON36593
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

- Women undergoing primary or adjuvant pelvic radiotherapy for cervical cancer
- Aged 18 years or older
- Able to complete a Dutch questionnaire
- Written informed consent

Exclusion Criteria

- Previous surgery of the lower urinary tract
- (Supra-pubic) catheter in situ
- Intermittent catheterisation because of bladder retention
- Intravesical treatment * 6 months prior to inclusion
- Urinary tract infection * 60 days prior to inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in Overactive Bladder domain score of the Urogenital Distress<br /><br>Inventory (UDI), as measured 12 weeks after the patient received the first<br /><br>instillation, between the intervention and control group</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cost-efficiency of intravesical instillations with 0.2% chondroitin sulphate<br /><br>solution to patients undergoing pelvic radiotherapy for cervical cancer</p><br>