Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis

NCT07016451 | Completed Early Phase 1 DMC

• 1 other identifier: MURA2023/837
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Radiation cystitis; Li-ESWT

Outcome Measures

Primary Outcomes (1)

• Symptoms

  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.

  Before, 1, and 3 months after treatment

Secondary Outcomes (1)

• Urine Molecular Analysis

  Before, 1, and 3 months after treatment

Other Outcomes (1)

• Urine analysis

  Before, 1, and 3 months after treatment

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Medication

Li-ESWT

EXPERIMENTAL

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

Procedure: Li-ESWT; Drug: Medication

Interventions

Li-ESWT PROCEDURE

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

Li-ESWT

Medication 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

Control; Li-ESWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thanakrit Visuthikosol: lead
• Ramathibodi Hospital: collaborator

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thanakrit Visuthikosol, MD

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 11, 2025
• Study Start: April 2, 2024
• Primary Completion: September 18, 2025
• Study Completion: March 31, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

TH (1)