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

NCT05337813 | Unknown

• 1 other identifier: KMUHIRB-F(I)-20200050
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.

Conditions

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

Keywords

LiESWT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (4)

A. Overactive bladder

EXPERIMENTAL

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

Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

B. Stress incontinence

EXPERIMENTAL

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

C. Interstitial cystitis

EXPERIMENTAL

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

D. Female sexual dysfunction

EXPERIMENTAL

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

Device: "Storz Medical" Extracoporeeal Shock Wave Therapy System

Interventions

"Storz Medical" Extracoporeeal Shock Wave Therapy System DEVICE

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)

Also known as: AEON PRP: APA-15

A. Overactive bladder; B. Stress incontinence; C. Interstitial cystitis; D. Female sexual dysfunction

Eligibility Criteria

• Age: 20 Years - 99 Years
• Gender Eligibility Details: women with pelvic floor dysfunction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, Sanmin Dist, 80756, Taiwan

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Stress; Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Cystitis

Central Study Contacts

Cheng-Yu Long, Professor

CONTACT

+886-7-3121101; urolong@yahoo.com.tw

Kun-Ling Lin, Asst. Prof.

CONTACT

+886-7-3121101; nancylin95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Only one arm for each disease (LiESWT group)

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 20, 2022
• Study Start: April 10, 2020
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)