Physical therapy and HIFEM for pelvic organ prolapse
Physical Therapy Intervention for Pelvic Organ Prolapses
This pilot will test whether high-intensity focused electromagnetic therapy (HIFEM) or pelvic floor muscle training with biofeedback reduce symptoms in women with stage 1–3 pelvic organ prolapse compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06532292 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center randomized pilot with 21 women allocated to three groups: HIFEM, PFMT with biofeedback, or usual care. Treatments are noninvasive and clinic-based, with HIFEM delivered while the patient is seated and fully clothed and PFMT provided with biofeedback support. The trial will compare patient-centered symptom outcomes and include a nested qualitative interview study to explore acceptability. Outcomes will inform feasibility and preliminary effectiveness for larger trials.
Who should consider this trial
Good fit: Women over 20 with stage 1–3 pelvic organ prolapse who are not pregnant, have not had recent pelvic surgery, and can attend visits at the Taipei study site are ideal candidates.
Not a fit: Women with stage 4 prolapse, pelvic tumors, recent pelvic surgery, metal implants or other device contraindications, severe vaginal atrophy or infection, neurologic disorders, or those already receiving pelvic physiotherapy are unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, these noninvasive interventions could reduce prolapse symptoms and help some women delay or avoid surgery.
How similar studies have performed: Pelvic floor muscle training and biofeedback are established first-line treatments for POP, while HIFEM has shown promise for urinary incontinence but has not been rigorously tested for pelvic organ prolapse.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Kuan-Yin Lin, PhD — National Taiwan University
- Study coordinator: Kuan-Yin Lin, PhD
- Email: kuanyinl27173@ntu.edu.tw
- Phone: +886-2-33668138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.