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

Kaohsiung Medical University

Status: Unknown

Conditions: Interstitial Cystitis; Female Sexual Dysfunction; Stress Incontinence; Overactive Bladder

Treatments: Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

Study type: Interventional

Funder types: Other

Identifiers

NCT05337813

KMUHIRB-F(I)-20200050

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

A. Overactive bladder

Experimental group

Description:

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

Treatment:

Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

B. Stress incontinence

Experimental group

Description:

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

Treatment:

Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

C. Interstitial cystitis

Experimental group

Description:

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

Treatment:

Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

D. Female sexual dysfunction

Experimental group

Description:

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

Treatment:

Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System