Radiation Cystitis
Conditions
Keywords
Radiation cystitis, Li-ESWT
Brief summary
Radiation-induced cystitis is a condition commonly seen in patients who have undergone radiation therapy, especially those treated in the pelvic region. Symptoms typically manifest after radiation exposure and may include dysuria (painful urination), increased urinary frequency during both day and night, and hematuria (blood in the urine), which can range from mild to severe. Currently, treatment is symptomatic, as there is no definitive cure for radiation cystitis. Management includes medications to alleviate symptoms, cystoscopic interventions to control bleeding, intravesical instillations, and in severe cases, surgical procedures to divert the urinary tract. Recently, low-intensity extracorporeal shock wave therapy (Li-ESWT) has been used to treat various urological conditions, including chronic prostatitis, chronic cystitis, overactive bladder, erectile dysfunction, and as an adjunct to enhance drug delivery into the bladder. This modality has shown potential to reduce inflammation, promote angiogenesis (formation of new blood vessels), regenerate tissues, and restore neural function. For patients with radiation cystitis, particularly those with prostate cancer who have received pelvic radiation, shock wave therapy is being explored for its ability to alleviate bladder pain and inflammation. This approach is similar to its use in non-bacterial cystitis and overactive bladder conditions. Studies have identified elevated levels of specific proteins in the urine of patients with radiation-induced cystitis, including markers of fibrosis, angiogenesis, and inflammation, which differ from those found in non-irradiated individuals. The anticipated benefit of this study is to provide data on clinical symptoms and treatment safety, potentially offering a novel therapeutic strategy for managing radiation-induced cystitis.
Interventions
DRUGMedication
The medication treatment of Radiation cystitis and relevant symptoms such as Antimuscarinics, Beta3 agonist, and pain control, as listed. Antimuscarinic Agents * Oxybutynin * Tolterodine * Solifenacin * Darifenacin * Trospium * Fesoterodine β3-Adrenergic Agonists * Mirabegron Pain Control Medications * Paracetamol * NSAIDs (e.g., Ibuprofen, Diclofenac) * Phenazopyridine * Amitriptyline * Gabapentin / Pregabalin
PROCEDURELi-ESWT
The intervention treatment uses Li-ESWT. (Dornier Aries® devices, Power 0.29mj/m² and 3000 shocks per week for 4 weeks)
Sponsors
Thanakrit Visuthikosol
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Criteria for diagnosis of radiation-induced cystitis and a history of pelvic radiation therapy administered more than 6 months prior. * Aged 18 years or older. * Willing to participate in the research study by providing written informed consent.
Exclusion criteria
* Active urinary tract infection within the past 6 months. * Active and uncontrolled gross hematuria. * Patients currently have a urinary diversion or abdominal ostomy. * Patients with anuria due to chronic kidney failure. * Uncontrolled coagulopathy. * Refuse participation, withdraw from the study, or experience severe adverse effects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | Before, 1, and 3 months after treatment | In each study group, comparative analysis of symptoms such as urination frequency, nocturia, dysuria, and incontinence is conducted before and after treatment. Each parameter is recorded by the patient in a bladder diary, capturing the frequency and intensity of symptoms experienced daily for the preceding three days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Molecular Analysis | Before, 1, and 3 months after treatment | Report the number and compare before and after treatment. Each study patient group's molecular analysis of inflammation, fibrosis, and vasculogenesis. Fibrosis: PAI 1, TIMP1, and TIMP2 inflammatory: IL-1a, IL-6, and MIP-1a Vascular maker: HGF, and VEGF-A |
Countries
Thailand
Outcome results
None listed