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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05337813
Collaborator
(none)
120
Enrollment
1
Location
4
Arms
35.6
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Only one arm for each disease (LiESWT group)Only one arm for each disease (LiESWT group)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction
Actual Study Start Date :
Apr 10, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: A. Overactive bladder

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

Device: "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)
Other Names:
  • AEON PRP: APA-15

    		•
    Experimental: B. Stress incontinence

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

    Device: "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)
    Other Names:
  • AEON PRP: APA-15

    		•
    Experimental: C. Interstitial cystitis

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

    Device: "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)
    Other Names:
  • AEON PRP: APA-15

    		•
    Experimental: D. Female sexual dysfunction

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

    Device: "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)
    Other Names:
  • AEON PRP: APA-15

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduce bladder leakage and symptoms of overactive bladder, including urgency, incontinence and nocturia. [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

    2. Assess the patient for changes in lower abdominal pain [8 months]

      VAS pain index record before and after treatment

    Secondary Outcome Measures

    1. Promote the repair and proliferation of blood vessels in the vulva to improve sexual function and improve the overall quality of sexual life. [2 months]

      Doppler ultrasound of the vulva to record the degree of blood congestion before and after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. One of the following symptoms can be included:

    2. Overactive bladder

    3. Stress incontinence

    4. Interstitial cystitis

    5. Not Menopause and female sexual dysfunction (FSFI scores< 26)

    6. The blood test confirmed that the number of platelets was 150,000 to 450,000 / UL, and the coagulation function (PT) index was normal.

    7. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) Kaohsiung Sanmin Dist Taiwan 80756

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05337813
    Other Study ID Numbers:
    • KMUHIRB-F(I)-20200050
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    LiESWT
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Cystitis
    Cystitis, Interstitial
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Apr 20, 2022