None listed
Conditions
Brief summary
Established treatments for radiation cystitis (diathermy, hyperbaric oxygen and intravesical instillations) have high failure rates and complication rates. RADA 16 is approved for and has been used extensively for haemostasis in surgery. Protocols for its use in the treatment for radiation proctitis are also well established. For radiation cystitis there is a single case report and a case series (of which the CPI is the primary author) for UK patients. These have both demonstrated good outcomes for patients who otherwise are facing either palliation or complex, salvage surgery which many of these patients may not be fit to undergo. More research is needed to establish if this is a treatment that would be beneficial for a cohort of patients with refractory haematuria from radiation cystitis, a debilitating condition often requiring substantial use of hospital resources.
Interventions
- A urologist will apply RADA16 (Purastat- 3 or 5 ml depending on the extent of the radiation cystitis) via a cystoscopy under general or local anaesthetic. This is applied during the surgery (cystoscopy). It is done as a day procedure in a hospital. The patient will be discharged the same day
- RADA 16 (Purastat) is a gel which is licensed for haemostasis and has been used effectively to treat radiation proctitis and there have been limited case series on its in radiation cystitis
- The procedu
- A urologist will apply RADA16 (Purastat- 3 or 5 ml depending on the extent of the radiation cystitis) via a cystoscopy under general or local anaesthetic. This is applied during the surgery (cystoscopy). It is done as a day procedure in a hospital. The patient will be discharged the same day - RADA 16 (Purastat) is a gel which is licensed for haemostasis and has been used effectively to treat radiation proctitis and there have been limited case series on its in radiation cystitis - The procedure takes about 30 mins to perform - The frequency will be dictated by the response to treatment- some people will only have one application, some people may have multiple applications if they still bleed from radiation cystitis. There is no limit to the number of applications for this study. - Urologists in this trial will not need any special training to perform this procedure as it is straightforward and within their usual scope of practice - Audit of operation procedures will be used to monitor adherence to intervention
Sponsors
Sydney Unversity
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patients 18 years and over old - Background of abdominopelvic radiotherapy - Clinically significant haematuria secondary to known or suspected radiation cystitis (confirmed during study if not previously). “Clinically significant haematuria” = ANY of the below criteria Resulting in previous or current hospital admission/presentations AND/OR Anaemia* AND/OR Requiring previous or ongoing blood transfusion AND/OR Intravesical clot formation AND/OR Previously or currently requiring intervention including but not limited to: hospital admission, in-dwelling catheterisation, continuous bladder irrigation, bladder washouts, surgical, interventional radiology or cystoscopic intervention with or without cystodiathermy, intravesical instillations or irrigation such as alum, ilauril, or formalin, blood transfusions AND/OR Severe enough to cause symptoms for the patient** AND/OR Recurrent macro haematuria prompting the patient to seek Urology review and management *Anaemia in this setting is defined as: - An acute drop in haemoglobin by at least 10 g/l, associated with haematuria OR - Chronic if Hb < 130 g/l (according to normal reference ranges provided by WHO for men; 110-129 g/l -mild anaemia, 80-109 g/l moderate, <80 g/l severe) OR - Ongoing/active bleeding which does not satisfy these two criteria, but the clinician is concerned about the severity of bleeding will ultimately result in anaemia over time. ** Symptoms of EITHER: - symptomatic anaemia with fatigue/lethargy, shortness of breath on exertion or chest pain, OR - lower urinary tract symptoms expected to be secondary to clots, such as sensation of incomplete emptying, urinary frequency, urinary retention
Exclusion criteria
Alternative diagnosis to radiation cystitis found at time of cystoscopy (e.g. bladder tumour) Patients with acute concurrent urosepsis – can be recruited after resolution Patients deemed too high risk or unwell to facilitate intervention
Outcome results
None listed