Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction

NCT ID: NCT05337813

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2023-03-31

Brief Summary

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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. LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.

Detailed Description

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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).

Conditions

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Overactive Bladder Stress Incontinence Interstitial Cystitis Female Sexual Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Only one arm for each disease (LiESWT group)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A. Overactive bladder

Overactive bladder (LiESWT therapy once a week, duration 8 weeks)

Group Type EXPERIMENTAL

"Storz Medical" Extracoporeeal Shock Wave Therapy System

Intervention Type DEVICE

A. 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)

B. Stress incontinence

Stress incontinence (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months)

Group Type EXPERIMENTAL

"Storz Medical" Extracoporeeal Shock Wave Therapy System

Intervention Type DEVICE

A. 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)

C. Interstitial cystitis

Interstitial cystitis (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months)

Group Type EXPERIMENTAL

"Storz Medical" Extracoporeeal Shock Wave Therapy System

Intervention Type DEVICE

A. 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)

D. Female sexual dysfunction

Female sexual dysfunction (LiESWT therapy once a week, duration 8 weeks)

Group Type EXPERIMENTAL

"Storz Medical" Extracoporeeal Shock Wave Therapy System

Intervention Type DEVICE

A. 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)

Interventions

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"Storz Medical" Extracoporeeal Shock Wave Therapy System

A. 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)

Intervention Type DEVICE

Other Intervention Names

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AEON PRP: APA-15

Eligibility Criteria

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Inclusion Criteria

1. One of the following symptoms can be included:

1. Overactive bladder
2. Stress incontinence
3. Interstitial cystitis
4. Not Menopause and female sexual dysfunction (FSFI scores\< 26)
2. The blood test confirmed that the number of platelets was 150,000 to 450,000 / UL, and the coagulation function (PT) index was normal.
3. Women over 20 years.

Exclusion Criteria

1. No UTI during the past week.
2. Patients with poorly controlled diabetes, spinal cord injury, brain disease and neurogenic disease.
3. urinary symptoms of inflammation(Bladder stones、hematuria、urethral syndrome).
4. Patients with acute or chronic infectious diseases.
5. Patients with acute or chronic cardiovascular disease.
6. Patients with a history of chronic liver and kidney disease.
7. Patients receiving anticoagulant therapy(Aspirin and NSAIDs COX-1).
8. Patients with bleeding disorders.
9. Receive low energy extracorporeal shock wave treatment within 1 month before entering the trial.
10. Urinary incontinence need to install the catheter.
11. Pregnant women.
12. Unable to sign the consent form.
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, Sanmin Dist, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Cheng-Yu Long, Professor

Role: CONTACT

+886-7-3121101 ext. 6428

Kun-Ling Lin, Asst. Prof.

Role: CONTACT

+886-7-3121101 ext. 6428

Facility Contacts

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Cheng-Yu Long, Professor

Role: primary

+886-7-3121101 ext. 6428

Other Identifiers

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KMUHIRB-F(I)-20200050

Identifier Type: -

Identifier Source: org_study_id

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