Cystistat® for Radiation Cystitis Pilot Study
Research type
Research Study
Full title
Cystistat® for Radiation Cystitis Pilot Study
IRAS ID
144248
Contact name
Heather Payne
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2014/05/50, UCL Data Protection Registration
Research summary
Hormone therapy combined with internal radiotherapy to the prostate (brachytherapy)and external beam radiotherapy is a common approach to the treatment of prostate cancer. Despite improvements in the delivery and targeting of radiotherapy, there remains a significant potential for the development of radiotherapy induced injury to nearby, normal, healthy organs. In the bladder, such tissue damage and scarring can lead to symptoms such as needing to pass urine more frequently during the day and night, not being able to wait to urinate, pain on passing urine or blood in the urine. Rarely, damage to the bladder may be very severe and require an operation to remove it to stop further problems.
Sodium hyaluronate solution (Cystistat®) has previously been successfully used to try to prevent and to treat damage to the bladder caused by radiation. However, so far whether cystistat may be helpful for men receiving internal and external radiotherapy for prostate cancer has not been tested. This study aims to find out if cystistat may reduce or prevent urinary side effects in men receiving these treatments for prostate cancer. This will be compared with the current standard practice, which is no specific treatment to help prevent these problems occurring.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1090
Date of REC Opinion
27 Aug 2014
REC opinion
Favourable Opinion