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

Study Overview
=================
Brief Summary
-----------------
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. LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.

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).

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

Conditions
-----------------
Overactive Bladder, Stress Incontinence, Interstitial Cystitis, Female Sexual Dysfunction

Intervention / Treatment
-----------------
* Device: Storz Medical Extracoporeeal Shock Wave Therapy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One of the following symptoms can be included: Overactive bladder Stress incontinence Interstitial cystitis Not Menopause and female sexual dysfunction (FSFI scores< 26) The blood test confirmed that the number of platelets was 150,000 to 450,000 / UL, and the coagulation function (PT) index was normal. Women over 20 years. Exclusion Criteria: No UTI during the past week. Patients with poorly controlled diabetes, spinal cord injury, brain disease and neurogenic disease. urinary symptoms of inflammation(Bladder stones、hematuria、urethral syndrome). Patients with acute or chronic infectious diseases. Patients with acute or chronic cardiovascular disease. Patients with a history of chronic liver and kidney disease. Patients receiving anticoagulant therapy(Aspirin and NSAIDs COX-1). Patients with bleeding disorders. Receive low energy extracorporeal shock wave treatment within 1 month before entering the trial. Urinary incontinence need to install the catheter. Pregnant women. Unable to sign the consent form.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Only one arm for each disease (LiESWT group)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A. Overactive bladder<br>Overactive bladder (LiESWT therapy once a week, duration 8 weeks) | Device: Storz Medical Extracoporeeal Shock Wave Therapy System<br>* 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)<br>* Other names: AEON PRP: APA-15;|
| Experimental: B. Stress incontinence<br>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<br>* 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)<br>* Other names: AEON PRP: APA-15;|
| Experimental: C. Interstitial cystitis<br>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<br>* 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)<br>* Other names: AEON PRP: APA-15;|
| Experimental: D. Female sexual dysfunction<br>Female sexual dysfunction (LiESWT therapy once a week, duration 8 weeks) | Device: Storz Medical Extracoporeeal Shock Wave Therapy System<br>* 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)<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LiESWT