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

Last updated: April 14, 2022
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Interstitial Cystitis

Sexual Dysfunction

Gynecological Infections

Treatment

N/A

Clinical Study ID

NCT05337813
KMUHIRB-F(I)-20200050
  • Ages 20-99
  • Female

Study 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.

Eligibility Criteria

Inclusion

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, andthe coagulation function (PT) index was normal.
  7. Women over 20 years.

Exclusion

Exclusion Criteria:

  1. No UTI during the past week.
  2. Patients with poorly controlled diabetes, spinal cord injury, brain disease andneurogenic 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 enteringthe trial.
  10. Urinary incontinence need to install the catheter.
  11. Pregnant women.
  12. Unable to sign the consent form.

Study Design

Total Participants: 120
Study Start date:
April 10, 2020
Estimated Completion Date:
March 31, 2023

Study 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).

Connect with a study center

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung, Sanmin Dist 80756
    Taiwan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.