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

Not Applicable

• Conditions: Stress Incontinence; Female Sexual Dysfunction; Overactive Bladder; Interstitial Cystitis
• Interventions: Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

• Registration Number: NCT05337813
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

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 Timeline

• Study Start: 2020-04-10
• Study First Submitted: 2022-03-21
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-09-30
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A. Overactive bladder	"Storz Medical" Extracoporeeal Shock Wave Therapy System	Overactive bladder (LiESWT therapy once a week, duration 8 weeks)
B. Stress incontinence	"Storz Medical" Extracoporeeal Shock Wave Therapy System	Stress incontinence (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months)
D. Female sexual dysfunction	"Storz Medical" Extracoporeeal Shock Wave Therapy System	Female sexual dysfunction (LiESWT therapy once a week, duration 8 weeks)
C. Interstitial cystitis	"Storz Medical" Extracoporeeal Shock Wave Therapy System	Interstitial cystitis (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months)

Primary Outcome Measures

Name	Time	Method
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
Assess the patient for changes in lower abdominal pain	8 months	VAS pain index record before and after treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH); 🇨🇳 Kaohsiung, Sanmin Dist, Taiwan