NCT05337813

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-04-10
• Primary completion: 2022-09-30
• Completion: 2023-03-31
• First posted: 2022-04-20
• Last updated: 2022-04-20

Locations

1 site across 1 country: Taiwan