Overactive BladderNCT05337813
Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction
A study testing "Storz Medical" Extracoporeeal Shock Wave Therapy System in people with Overactive Bladder and Stress Incontinence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
1. This study needles female reproductive urinary tract, likely bladder hyperactivity, active urinary incontinence and interstitial cystitis, observation use of low-capacity seismic wave (LiESWT) therapy combined with combined platelet plasma (PRP), improved bone basin pain and female Urinary incontinence. 2. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Overactive Bladder, Stress Incontinence, Interstitial Cystitis
- What is being tested?
- "Storz Medical" Extracoporeeal Shock Wave Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Apr 2020to 31 Mar 2023
- Phase
- Interventional
- 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 20 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One of the following symptoms can be included:
- Overactive bladder
- Stress incontinence
- Interstitial cystitis
- Not Menopause and female sexual dysfunction (FSFI scores< 26)
- The blood test confirmed that the number of platelets was 150,000 to 450,000 / UL, and the coagulation function (PT) index was normal.
- Women over 20 years.
Who cannot join
- No UTI during the past week.
- Patients with poorly controlled diabetes, spinal cord injury, brain disease and neurogenic disease.
- urinary symptoms of inflammation(Bladder stones、hematuria、urethral syndrome).
- Patients with acute or chronic infectious diseases.
- Patients with acute or chronic cardiovascular disease.
- Patients with a history of chronic liver and kidney disease.
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- Patients receiving anticoagulant therapy(Aspirin and NSAIDs COX-1).
- Patients with bleeding disorders.
- Receive low energy extracorporeal shock wave treatment within 1 month before entering the trial.
- Urinary incontinence need to install the catheter.
- Pregnant women.
- Unable to sign the consent form.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Sanmin Dist, 80756
Cheng-Yu Long, Professor, +886-7-3121101 ext. 6428, urolong@yahoo.com.tw
About this study
- This study needles female reproductive urinary tract, likely bladder hyperactivity, active urinary incontinence and interstitial cystitis, observation use of low-capacity seismic wave (LiESWT) therapy combined with combined platelet plasma (PRP), improved bone basin pain and female Urinary incontinence.
- LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.
Read the detailed description
Collect 120 women(A. Overactive bladder、B. Stress incontinence、C. Interstitial cystitis D. Female sexual dysfunction), Low Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 8 weeks(B.、C. PRP treatment at 1, 5, 9 weeks), and to complete all treatment after 4 weeks and 24 weeks back to the clinic, evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI)、Urinary tract dynamics test、Urination log、Cotton pad test、Blood test(ESR、CA125、CBC、CRP). ○DLow Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 4 weeks, and to complete all treatment 4th and after 4 weeks back to the clinic, Pelvic Doppler ultrasound ,evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI).
- Being tested
- "Storz Medical" Extracoporeeal Shock Wave Therapy System
- Keywords
- LiESWT
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Stress, Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Storz Medical" Extracoporeeal Shock Wave Therapy SystemDevice
Also called AEON PRP: APA-15
- B. C. D. groups need to Low Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 8 weeks(B.、C. groups needs to be combined PRP treatment at 1, 5, 9 weeks)
| Study group | Role | What they receive |
|---|---|---|
| A. Overactive bladder | Experimental | Overactive bladder (LiESWT therapy once a week, duration 8 weeks) Receives: Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System |
| B. Stress incontinence | Experimental | Stress incontinence (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months) Receives: Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System |
| C. Interstitial cystitis | Experimental | Interstitial cystitis (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months) Receives: Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System |
| D. Female sexual dysfunction | Experimental | Female sexual dysfunction (LiESWT therapy once a week, duration 8 weeks) Receives: Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce bladder leakage and symptoms of overactive bladder, including urgency, incontinence and nocturia.
1.Questionnaire assessment before and after treatment (OABSS, UDI-6, IIQ-7, ICIQ-SF, POPDI-6, FSFI) . 2.urodynamic examination before and after treatment
Measured: 8 months
Assess the patient for changes in lower abdominal pain
VAS pain index record before and after treatment
Measured: 8 months
Secondary outcomes (1)
Promote the repair and proliferation of blood vessels in the vulva to improve sexual function and improve the overall quality of sexual life.
Doppler ultrasound of the vulva to record the degree of blood congestion before and after treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start10 Apr 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Only one arm for each disease (LiESWT group)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337813
- Sponsor's protocol ID
- KMUHIRB-F(I)-20200050
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT05337813
- Acronym / sponsor ID
- KMUHIRB-F(I)-20200050
- Keywords
- LiESWT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 20 Apr 2022 (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.
- This study needles female reproductive urinary tract, likely bladder hyperactivity, active urinary incontinence and interstitial cystitis, observation use of low-capacity seismic wave (LiESWT) therapy combined with combined platelet plasma (PRP), improved bone basin pain and female Urinary incontinence.
- LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.
Detailed description
Collect 120 women(A. Overactive bladder、B. Stress incontinence、C. Interstitial cystitis D. Female sexual dysfunction), Low Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 8 weeks(B.、C. PRP treatment at 1, 5, 9 weeks), and to complete all treatment after 4 weeks and 24 weeks back to the clinic, evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI)、Urinary tract dynamics test、Urination log、Cotton pad test、Blood test(ESR、CA125、CBC、CRP). ○DLow Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 4 weeks, and to complete all treatment 4th and after 4 weeks back to the clinic, Pelvic Doppler ultrasound ,evaluation questionnaire (OABSS、UDI-6、IIQ-7、ICIQ-SF、POPDI-6、FSFI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Only one arm for each disease (LiESWT group)
| Arm | Type | Receives |
|---|---|---|
| A. Overactive bladder | Experimental | Device: "Storz Medical" Extracoporeeal Shock Wave Therapy SystemOveractive bladder (LiESWT therapy once a week, duration 8 weeks) |
| B. Stress incontinence | Experimental | Device: "Storz Medical" Extracoporeeal Shock Wave Therapy SystemStress incontinence (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months) |
| C. Interstitial cystitis | Experimental | Device: "Storz Medical" Extracoporeeal Shock Wave Therapy SystemInterstitial cystitis (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months) |
| D. Female sexual dysfunction | Experimental | Device: "Storz Medical" Extracoporeeal Shock Wave Therapy SystemFemale sexual dysfunction (LiESWT therapy once a week, duration 8 weeks) |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- One of the following symptoms can be included:
- The blood test confirmed that the number of platelets was 150,000 to 450,000 / UL, and the coagulation function (PT) index was normal.
- Women over 20 years.
Key exclusion criteria (12 listed)
- No UTI during the past week.
- Patients with poorly controlled diabetes, spinal cord injury, brain disease and neurogenic disease.
- urinary symptoms of inflammation(Bladder stones、hematuria、urethral syndrome).
- Patients with acute or chronic infectious diseases.
- Patients with acute or chronic cardiovascular disease.
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 |
|---|---|---|
| "Storz Medical" Extracoporeeal Shock Wave Therapy SystemAlso: AEON PRP: APA-15A. B. C. D. groups need to Low Energy Extracorporeal Shock Wave (LiESWT) therapy once a week, duration 8 weeks(B.、C. groups needs to be combined PRP treatment at 1, 5, 9 weeks) | Device | A. Overactive bladder, B. Stress incontinence, C. Interstitial cystitis, D. Female sexual dysfunction |
Primary outcome
Reduce bladder leakage and symptoms of overactive bladder, including urgency, incontinence and nocturia.
Time frame: 8 months
1.Questionnaire assessment before and after treatment (OABSS, UDI-6, IIQ-7, ICIQ-SF, POPDI-6, FSFI) . 2.urodynamic examination before and after treatment
Assess the patient for changes in lower abdominal pain
Time frame: 8 months
VAS pain index record before and after treatment
1 secondary outcome
Promote the repair and proliferation of blood vessels in the vulva to improve sexual function and improve the overall quality of sexual life.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Storz Medical" Extracoporeeal Shock Wave Therapy System in people with Overactive Bladder and Stress Incontinence, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Yu Long, Professor (+886-7-3121101 ext. 6428, urolong@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce bladder leakage and symptoms of overactive bladder, including urgency, incontinence and nocturia. (time frame: 8 months). The study lists 2 primary outcomes in all. 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 20 Apr 2022.