Radiation CystitisEarly Phase 1NCT07016451
Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis
A Early Phase 1 study testing Li-ESWT and Medication in people with Radiation Cystitis, run by Thanakrit Visuthikosol at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Cystitis
- What is being tested?
- Li-ESWT and Medication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteThailand
- Study dates
- 2 Apr 2024to 31 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-intensity Extracorporeal Shockwaves in the Treatment of Radiation Cystitis, Randomized Controlled Trial
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.
Read more
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
- Being tested
- Li-ESWT, Medication
- Keywords
- Radiation cystitis, Li-ESWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Li-ESWTProcedure or surgery
The intervention treatment uses Li-ESWT. (Dornier Aries® devices, Power 0.29mj/m² and 3000 shocks per week for 4 weeks)
MedicationDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patient receives the treatment, medication or intervention that not included Li-ESWT Receives: 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 Receives: Procedure: Li-ESWT; Drug: Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before, 1, and 3 months after treatment
Secondary outcomes (1)
Urine Molecular Analysis
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
Measured: Before, 1, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start2 Apr 2024
- Primary completion18 Sep 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thanakrit Visuthikosol
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital
- Responsible party
- Sponsor-investigator, Thanakrit Visuthikosol, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016451
- Sponsor's protocol ID
- MURA2023/837
- Status last verified
- May 2026
- First submitted
- 13 May 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are still evaluating whether to share individual participant data (IPD) from this study on low-intensity extracorporeal shock wave therapy (Li-ESWT) for radiation-induced cystitis. Key considerations include ensuring adequate de-identification of sensitive clinical data, addressing patient consent for secondary use, and complying with institutional and ethical guidelines. Additionally, due to the relatively small sample size and the potential for indirect re-identification, we are carefully assessing the risks and benefits of IPD sharing. A decision will be made once these factors have been thoroughly reviewed in consultation with our ethics board and institutional data governance policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-intensity Extracorporeal Shockwaves in the Treatment of Radiation Cystitis, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07016451
- Acronym / sponsor ID
- MURA2023/837
- Conditions
- Radiation Cystitis
- Keywords
- Radiation cystitis, Li-ESWT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Thanakrit VisuthikosolUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: MedicationPatient receives the treatment, medication or intervention that not included Li-ESWT |
| Li-ESWT | Experimental | Procedure: Li-ESWT, Drug: MedicationThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Li-ESWTThe intervention treatment uses Li-ESWT. (Dornier Aries® devices, Power 0.29mj/m² and 3000 shocks per week for 4 weeks) | Procedure or surgery | Li-ESWT |
| MedicationThe 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 | Drug | Control, Li-ESWT |
Primary outcome
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.
1 secondary outcome
Urine Molecular Analysis
Time frame: Before, 1, and 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided. We are still evaluating whether to share individual participant data (IPD) from this study on low-intensity extracorporeal shock wave therapy (Li-ESWT) for radiation-induced cystitis. Key considerations include ensuring adequate de-identification of sensitive clinical data, addressing patient consent for secondary use, and complying with institutional and ethical guidelines. Additionally, due to the relatively small sample size and the potential for indirect re-identification, we are carefully assessing the risks and benefits of IPD sharing. A decision will be made once these factors have been thoroughly reviewed in consultation with our ethics board and institutional data governance policies.
Related trials for Radiation Cystitis
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Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
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Chronic Radiation Cystitis and Effect of Hyperbaric Oxygen Therapy on Patient Reported Outcomes and Urine Inflammatory Biomarkers
Radiation Cystitis, Urinary Tract Infection (Diagnosis)
Not yet recruitingEarly Phase 1
Clinical Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Combined With Sodium Hyaluronate Intravesical Instillation in the Treatment of Radiation Cystitis
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RecruitingObservational study
Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)
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Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Li-ESWT and Medication in people with Radiation Cystitis, run by Thanakrit Visuthikosol at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: Before, 1, and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.