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

Primary Purpose

Overactive Bladder, Stress Incontinence, Interstitial Cystitis

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
"Storz Medical" Extracoporeeal Shock Wave Therapy System
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring LiESWT

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A. Overactive bladder

B. Stress incontinence

C. Interstitial cystitis

D. Female sexual dysfunction

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
Assess the patient for changes in lower abdominal pain
VAS pain index record before and after treatment

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2022
Last Updated
April 14, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05337813
Brief Title
Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction
Official Title
Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Stress Incontinence, Interstitial Cystitis, Female Sexual Dysfunction
Keywords
LiESWT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Only one arm for each disease (LiESWT group)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A. Overactive bladder
Arm Type
Experimental
Arm Description
Overactive bladder (LiESWT therapy once a week, duration 8 weeks)
Arm Title
B. Stress incontinence
Arm Type
Experimental
Arm Description
Stress incontinence (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months)
Arm Title
C. Interstitial cystitis
Arm Type
Experimental
Arm Description
Interstitial cystitis (LiESWT therapy once a week, duration 8 weeks + PRP therapy once a month, duration 3 months)
Arm Title
D. Female sexual dysfunction
Arm Type
Experimental
Arm Description
Female sexual dysfunction (LiESWT therapy once a week, duration 8 weeks)
Intervention Type
Device
Intervention Name(s)
"Storz Medical" Extracoporeeal Shock Wave Therapy System
Other Intervention Name(s)
AEON PRP: APA-15
Intervention Description
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)
Primary Outcome Measure Information:
Title
Reduce bladder leakage and symptoms of overactive bladder, including urgency, incontinence and nocturia.
Description
1.Questionnaire assessment before and after treatment (OABSS, UDI-6, IIQ-7, ICIQ-SF, POPDI-6, FSFI) . 2.urodynamic examination before and after treatment
Time Frame
8 months
Title
Assess the patient for changes in lower abdominal pain
Description
VAS pain index record before and after treatment
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Promote the repair and proliferation of blood vessels in the vulva to improve sexual function and improve the overall quality of sexual life.
Description
Doppler ultrasound of the vulva to record the degree of blood congestion before and after treatment
Time Frame
2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with pelvic floor dysfunction
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Yu Long, Professor
Phone
+886-7-3121101
Ext
6428
Email
urolong@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Kun-Ling Lin, Asst. Prof.
Phone
+886-7-3121101
Ext
6428
Email
nancylin95@gmail.com
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
City
Kaohsiung
State/Province
Sanmin Dist
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Yu Long, Professor
Phone
+886-7-3121101
Ext
6428
Email
urolong@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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