Ramathibodi Hospital
Bangkok, 10400, Thailand
NCT Number: NCT07016451
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.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Bangkok, 10400, Thailand
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention treatment uses Li-ESWT. (Dornier Aries® devices, Power 0.29mj/m² and 3000 shocks per week for 4 weeks)
The medication treatment of Radiation cystitis and relevant symptoms such as Antimuscarinics, Beta3 agonist, and pain control, as listed. Antimuscarinic Agents
Time frame: 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.
Time frame: 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
Time frame: Before, 1, and 3 months after treatment
Urine analysis for WBC, RBC, and protein
Thanakrit Visuthikosol
Other
Low-intensity Extracorporeal Shockwaves in the Treatment of Radiation Cystitis, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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