Status:
RECRUITING
Physical Therapy Intervention for Pelvic Organ Prolapses
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
20+ years
Phase:
NA
Brief Summary
Pelvic floor muscle training (PFMT) and pessaries are first-line non-surgical conservative treatments for pelvic organ prolapse (POP). High-Intensity Focused Electromagnetic Field (HIFEM) is a noninva...
Detailed Description
Pelvic organ prolapse (POP) is a prevalent, non-malignant condition affecting 30% to 50% women, with roughly 30% of these women undergo surgical intervention due to related symptoms impacting their da...
Eligibility Criteria
Inclusion
- Women aged over 20 years
- Prolapse severity of stages 1, 2, or 3 in one or more compartments (anterior vaginal wall, uterine/cervical, vaginal vault, posterior vaginal wall)
Exclusion
- Stage 4 prolapse
- Tumor in the pelvic region
- A recent surgical procedure (within 6 months)
- Metal implants
- Severe physical/psychiatric impairments
- Pregnancy or planning to become pregnant during the next 2 months
- Severe vaginal atrophy
- Vaginal infectious disease
- Neurologic disorders
- Receiving physical therapy treatments for prolapse or urinary incontinence
- Any contraindication listed in the investigational device manual
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 9 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06532292
Start Date
August 5 2024
End Date
August 9 2026
Last Update
July 31 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan