Skip to main content
OpenTrials
Completed

NCT Number: NCT07016451

Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ramathibodi Hospital

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Li-ESWT

Procedure

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

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

Primary outcomes

  1. Symptoms

    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.

Secondary outcomes

  1. Urine Molecular Analysis

    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

Other outcomes

  1. Urine analysis

    Time frame: Before, 1, and 3 months after treatment

    Urine analysis for WBC, RBC, and protein

Sponsors and collaborators

Lead sponsor

Thanakrit Visuthikosol

Other

Collaborators

  • Ramathibodi Hospital

Registry information

Official study title

Low-intensity Extracorporeal Shockwaves in the Treatment of Radiation Cystitis, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.