Low-intensity Extracorporeal Shockwaves in the Treatment of Radiation Cystitis, Randomized Controlled Trial
| Registry | NCT07016451 |
|---|---|
| Status | Completed |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, single group, masking: single, treatment |
| Enrollment | 25 (Actual) |
| Sponsor | Thanakrit Visuthikosol (Other); collaborators: Ramathibodi Hospital |
| Conditions | Radiation Cystitis |
| Interventions | Li-ESWT, Medication (Procedure, drug) |
| Dates | start 2024-04-02, primary completion 2025-09-18, completion 2026-03-31, first posted 2025-06-11, last updated 2026-05-15 |
| Locations | 1 site in Thailand |
Related Papers Related Patents Related Grants Related Experts
All trials for Radiation Cystitis All trials of Li-ESWT All trials of Medication
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control | Active comparator | Drug: Medication | Patient receives the treatment, medication or intervention that not included Li-ESWT |
| Li-ESWT | Experimental | Procedure: Li-ESWT; Drug: Medication | The intervention treatment for Radiation cystitis mainly or only uses Li-ESWT. If the patients have regular medication for this disease, they will receive continuous treatment |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ramathibodi Hospital | Bangkok | Thailand |