Clinical trial NCT07016451: Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis
Official title: Low-intensity Extracorporeal Shockwaves in the Treatment of Radiation Cystitis, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Radiation Cystitis
Keywords: Radiation cystitis
Li-ESWT
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Ramathibodi Hospital
First posted: 2025-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptoms
timeFrame: Before, 1, and 3 months after treatment
Secondary outcomes:
measure: Urine Molecular Analysis
timeFrame: Before, 1, and 3 months after treatment
Other outcomes:
measure: Urine analysis
timeFrame: Before, 1, and 3 months after treatment
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
References: