Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis

NCT ID: NCT07016451

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2026-06-30

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.

Conditions

Radiation Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Patient receives the treatment, medication or intervention that not included Li-ESWT

Group Type: ACTIVE_COMPARATOR

Medication

Intervention Type: DRUG

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

Li-ESWT

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

Group Type: EXPERIMENTAL

Li-ESWT

Intervention Type: PROCEDURE

The intervention treatment uses Li-ESWT. (Dornier Aries® devices, Power 0.29mj/m² and 3000 shocks per week for 4 weeks)

Medication

Intervention Type: DRUG

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

Interventions

Li-ESWT

The intervention treatment uses Li-ESWT. (Dornier Aries® devices, Power 0.29mj/m² and 3000 shocks per week for 4 weeks)

Intervention Type: PROCEDURE

Medication

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramathibodi Hospital

OTHER

Sponsor Role: collaborator

Thanakrit Visuthikosol

OTHER

Sponsor Role: lead

Responsible Party

Thanakrit Visuthikosol

Thanakrit Visuthikosol, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ramathibodi Hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

MURA2023/837

Identifier Type: -

Identifier Source: org_study_id