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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337813
• Other study ID #: KMUHIRB-F(I)-20200050
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Cheng-Yu Long, Professor
• Phone: +886-7-3121101
• Email: urolong[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Female Sexual Dysfunction
• Interstitial Cystitis
• Overactive Bladder
• Stress Incontinence
• Urinary Bladder, Overactive
• Urinary Incontinence, Stress

Intervention

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)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)	Kaohsiung	Sanmin Dist

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assess the patient for changes in lower abdominal pain	VAS pain index record before and after treatment	8 months
Secondary	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