Stress Urinary IncontinenceNCT04059133

The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder

A study testing DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm in people with Stress Urinary Incontinence and Overactive Bladder, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The hypothesis of the present study is low intensity extracorporeal low energy shock wave therapy (LiESWT) can decrease inflammatory disorders, increase pelvic floor blood supply, enhanced bladder stem cell activation, Using LiESWT can decrease bladder overactivity, eliminate urinary incontinence and improve stress… Read more about this study

Who is it for?: Ages 20 to 75 years, women only
Conditions the study is for: Stress Urinary Incontinence, Overactive Bladder
What is being tested?: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteTaiwan
Study dates: 27 Feb 2018to 31 Jul 2020
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 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women patients within 20~75 years old;
OAB symptoms for ≥ 3 months;
Frequency of micturition ≥ 8 times daytime as well as 2 times nighttime, and ≥ 2 episodes of urgency per week;
Patients have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
Patients with OAB symptoms including urgency or/and urgency incontinence, urinary frequency and nocturia in the previous 3 months without medical treatments: antimuscarinic or ß3 agonist therapy;
Patients can understand, obey order and finish the questionnaires;
Patients would like to sign the informed consent;
Signature of informed consent form.

Who cannot join

Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months;
Patients who have other disease: diabetes mellitus, spinal cord injury, stoke history, brain disease and neurogenic disease which can cause OAB;
Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome);
Bladder stone;
History of carcinoma of the urinary tract;
Lower urinary tract surgery in the last 6 months;

Show all 24Show fewer

Patients who have operation, wound or infection around perineum;
Patients who have catheterization due to poor voiding function of urine;
Patients who have severe cardiovascular disease;
Patients who have severe coagulopathy or liver failure or renal failure;
Patients who have underlying urologic cancer;
Subjects with gross hematuria;
Significant bladder outflow obstruction;
Previous pelvic radiation therapy or previous, current malignant disease of the pelvic organs or having received intravesical injection or electrostimulation in the past 12 months;
Drug or nondrug treatments of OAB (in the previous 14 days), Concomitant medications that affect detrusor activity;
Subjects with history of kidneys stones;
Treatable condition that could cause urinary incontinence or urgency;
Neurological impairment or psychiatric disorder preventing appropriate understanding of consent and ability to comply with site personnel instructions;
History of drug or alcohol abuse within the last 12 months;
Within 1 month before entering the test and receive low-energy in vitro shock wave treatment process using antibiotics or phosphodiesterase inhibitors type 5 (PDE5i);
There are chronic pelvic pains caused by the merger of other diseases or injuries;
Urinary incontinence need to install the catheter;
Severe cardiopulmonary disease or diabetes is obviously poor control;
Obvious coagulation dysfunction or liver and kidney dysfunction.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting

Kaohsiung Medical University Hospital
Kaohsiung City, 807
Yung-Shun Juan, MD., PhD, 88673121101 ext. 6361, juanuro@gmail.com
Recruiting

Other trials in Taiwan

About this study

Read the detailed description

Clinical application of low intensity extracorporeal low energy shock wave therapy (LiESWT) (2000 to 3000 impulses in 0.20-0.25 millijoule/mm2 (mJ/mm2)) initiated wound healing, promoted angiogenesis, reduced the level of oxidative stress, induced the releasing of VEGF, stimulated proliferation and differentiation of stem cells, and resulted in the effect of anti-inflammatory and tissue regeneration. Generally, LiESWT was used clinically to improve tissue regeneration at tendon-bone junctions, ischemic cardiovascular disorders, skin wound healing, chronic injuries of soft tissues and erectile dysfunction.

LiESWT has also been shown to increase vascular endothelial growth factor (VEGF) expression in ischemic tissues in vivo and to promote angiogenesis and functional recovery in models of chronic myocardial ischemia, myocardial infarction, and peripheral artery disease. Importantly, the advantages of LiESWT include therapies without medication or surgery, outpatient therapies, short treatment sessions, no anesthesia required, and non-invasive therapy.

The hypothesis of the present study is LiESWT can decrease inflammatory disorders, increase pelvic floor blood supply, enhanced bladder stem cell activation, Using LiESWT can decrease bladder overactivity, eliminate urinary incontinence and improve stress urinary incontinence (SUI) and overactive bladder (OAB) symptoms. Therefore improve quality of life and improve social activity.

Conditions: Stress Urinary Incontinence, Overactive Bladder
Being tested: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm, DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm
Keywords: low intensity extracorporeal low energy shock wave therapy, stress urinary incontinence, overactive bladder, urine leakage
Medical subject headings: Urinary Incontinence, Stress, Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham armDevice
Sham treatment (shock wave probe w/o energy)
DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT armDevice
Low intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy)

Study groups in NCT04059133
Study group	Role	What they receive
LiESWT arm	Experimental	1. For SUI: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. 2. For OAB: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°, and the applicator was gently placed on suprapubic skin area over the bladder dome and bilateral bladder walls with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. Receives: Device: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm
Sham arm	Sham comparator	1. For SUI: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. 2. For OAB: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). The applicator was gently placed on the suprapubic skin area over the bladder dome (1000 pulses) and bilateral bladder walls (each side 1000 pulses). The probe was placed on the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°. Receives: Device: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Pad Weight Difference
The pad test quantifies in grams urinary loss through the absorbent weighing as a measure of stress urinary incontinence.
Measured: Data will be analyzed at study completion at approximately 3 years.
Overactive bladder symptoms scores (OABSS)
Change in OABSS scores during LiESWT treatment and follow-up period.
Measured: Data will be analyzed at study completion at approximately 3 years.
International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)
Change in ICIQ-SF scores during LiESWT treatment and follow-up period.
Measured: Data will be analyzed at study completion at approximately 3 years.
Urogenital distress inventory (UDI-6)
Change in UDI-6 scores during LiESWT treatment and follow-up period.
Measured: Data will be analyzed at study completion at approximately 3 years.
Incontinence impact questionnaire -7 (IIQ-7)
Change in IIQ-7 scores during LiESWT treatment and follow-up period.
Measured: Data will be analyzed at study completion at approximately 3 years.

Secondary outcomes (4)

maximum flow rate(Qmax=cc/s)
The maximum flow rate is the most important uroflowmetry index to diagnose bladder outlet obstruction or bladder contractility.
Measured: Data will be analyzed at study completion at approximately 3 years.
Uroflow
Uroflow curve pattern: There are 5 uroflow curve patterns, bell-shaped, tower-shaped, interrupted-shaped, staccato-shaped and plateau shaped by uroflowmetry. The shape is determined by detrusor contractility and influenced by abdominal straining, coordination with the bladder outlet musculature and any distal anatomic obstruction.
Measured: Data will be analyzed at study completion at approximately 3 years.
postvoid residual urine volume (PVR)
PVR (cc): ultrasonographic bladder scan machines calculates bladder volume. PVR measurements in neurologically intact children are highly variable. PVR must be obtained immediately after voiding(<5min).
Measured: Data will be analyzed at study completion at approximately 3 years.
3-day micturition diary
The mean number of Intake (ml), output (ml), average urine volume (ml), functional bladder capacity (ml), urinary frequency (times/24hrs), urgency (times), and nocturia (times) per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Measured: Data will be analyzed at study completion at approximately 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 201831 Jul 2020

First posted16 Aug 2019
Study start27 Feb 2018
Primary completion31 Jul 2020 (estimated)
Study completion31 Jul 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stress Urinary IncontinenceStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04059133
Sponsor's protocol ID: KMUHIRB-F(II)-20180010
Status last verified: Aug 2019
First submitted: 14 Aug 2019
Last updated: 20 Aug 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Long CY, Lin KL, Lee YC, Chuang SM, Lu JH, Wu BN, Chueh KS, Ker CR, Shen MC, Juan YS. Therapeutic effects of Low intensity extracorporeal low energy shock wave therapy (LiESWT) on stress urinary incontinence. Sci Rep. 2020 Apr 2;10(1):5818. doi: 10.1038/s41598-020-62471-4.
PubMed 32242035

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
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Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
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All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Low Intensity Extracorporeal Low Energy Shock Wave Therapy on Stress Urinary Incontinence and Overactivity Bladder
ClinicalTrials.gov ID: NCT04059133
Acronym / sponsor ID: KMUHIRB-F(II)-20180010
Conditions: Stress Urinary Incontinence, Overactive Bladder
Keywords: low intensity extracorporeal low energy shock wave therapy, stress urinary incontinence, overactive bladder, urine leakage
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 180 participants (estimated)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
Study start: 27 Feb 2018 (actual)
Primary completion: 31 Jul 2020 (estimated)
Study completion: 31 Jul 2020 (estimated)
First posted: 16 Aug 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
LiESWT arm	Experimental	Device: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm1. For SUI: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. 2. For OAB: The LiESWT was applied with 0.25 mJ/mm2 intensity, 3000 pulses of shocks, and frequency of 3 pulses/second, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°, and the applicator was gently placed on suprapubic skin area over the bladder dome and bilateral bladder walls with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually.
Sham arm	Sham comparator	Device: DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm1. For SUI: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). Probe be transcutaneous applied to the left and right labia minora of the genital area, and the applicator was gently placed on the middle, the left side and the right side of the labia with 0.25 mJ/mm2 intensity and 1000 pulses of shocks individually. 2. For OAB: The LiESWT was applied with 3000 pulses of shocks, frequency of 3 pulses/second but no energy, once weekly for 4-weeks (W4) and 8-weeks (W8). The applicator was gently placed on the suprapubic skin area over the bladder dome (1000 pulses) and bilateral bladder walls (each side 1000 pulses). The probe was placed on the lower abdomen with two fingers apart from the pubic symphysis, tilting to 45°.

Who may qualify

Ages: 20 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Women patients within 20~75 years old;
OAB symptoms for ≥ 3 months;
Frequency of micturition ≥ 8 times daytime as well as 2 times nighttime, and ≥ 2 episodes of urgency per week;
Patients have a ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) per week (self reported);
Patients with OAB symptoms including urgency or/and urgency incontinence, urinary frequency and nocturia in the previous 3 months without medical treatments: antimuscarinic or ß3 agonist therapy;

Key exclusion criteria (24 listed)

Urinary tract infection (UTI) at screening and recurrent UTI defined as ≥ 3 UTIs in the previous 12 months;
Patients who have other disease: diabetes mellitus, spinal cord injury, stoke history, brain disease and neurogenic disease which can cause OAB;
Chronic urologic inflammatory condition (Interstitial cystitis, urethral syndrome, painful bladder syndrome);
Bladder stone;
History of carcinoma of the urinary tract;

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
DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham armSham treatment (shock wave probe w/o energy)	Device	Sham arm
DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT armLow intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy)	Device	LiESWT arm

Primary outcome

Pad Weight Difference
Time frame: Data will be analyzed at study completion at approximately 3 years.
The pad test quantifies in grams urinary loss through the absorbent weighing as a measure of stress urinary incontinence.
Overactive bladder symptoms scores (OABSS)
Time frame: Data will be analyzed at study completion at approximately 3 years.
Change in OABSS scores during LiESWT treatment and follow-up period.
International Consultation on Incontinence Questionnaire -- Short Form (ICIQ-SF)
Time frame: Data will be analyzed at study completion at approximately 3 years.
Change in ICIQ-SF scores during LiESWT treatment and follow-up period.
Urogenital distress inventory (UDI-6)
Time frame: Data will be analyzed at study completion at approximately 3 years.
Change in UDI-6 scores during LiESWT treatment and follow-up period.
Incontinence impact questionnaire -7 (IIQ-7)
Time frame: Data will be analyzed at study completion at approximately 3 years.
Change in IIQ-7 scores during LiESWT treatment and follow-up period.

4 secondary outcomes

maximum flow rate(Qmax=cc/s)
Time frame: Data will be analyzed at study completion at approximately 3 years.
Uroflow
Time frame: Data will be analyzed at study completion at approximately 3 years.
postvoid residual urine volume (PVR)
Time frame: Data will be analyzed at study completion at approximately 3 years.
3-day micturition diary
Time frame: Data will be analyzed at study completion at approximately 3 years.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
Derived from this study: PubMed 32242035Long CY, Lin KL, Lee YC, Chuang SM, Lu JH, Wu BN, Chueh KS, Ker CR, Shen MC, Juan YS. Therapeutic effects of Low intensity extracorporeal low energy shock wave therapy (LiESWT) on stress urinary incontinence. Sci Rep. 2020 Apr 2;10(1):5818. doi: 10.1038/s41598-020-62471-4.
Individual participant dataSharing planned: No

Related trials for Stress Urinary Incontinence

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
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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.

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

88673121101 ext. 6361

juanuro@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 24 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 Aug 2019. 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pad Weight Difference (time frame: Data will be analyzed at study completion at approximately 3 years.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04059133, which also lists 1 linked publication.

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 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.