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

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Interstitial Cystitis; Female Sexual Dysfunction; Stress Incontinence
• Intervention / Treatment: Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng-Yu Long, Professor; Phone Number: 6428 +886-7-3121101; Email: urolong@yahoo.com.tw
• Study Contact Backup: Name: Kun-Ling Lin, Asst. Prof.; Phone Number: 6428 +886-7-3121101; Email: nancylin95@gmail.com

Study Locations

• Taiwan
  • Sanmin Dist
    • Kaohsiung, Sanmin Dist, Taiwan, 80756
      • Recruiting
      • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
      • Contact: Cheng-Yu Long, Professor; Phone Number: 6428 +886-7-3121101; Email: urolong@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 months
Assess the patient for changes in lower abdominal pain	VAS pain index record before and after treatment	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: LiESWT
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder, Overactive; Cystitis; Urinary Incontinence, Stress; Cystitis, Interstitial
• Other Study ID Numbers: KMUHIRB-F(I)-20200050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No