Physical Therapy Intervention for Pelvic Organ Prolapses

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 noninvasive and painless device, designed to promote muscle strengthening and growth and has become a popular treatment option for urinary incontinence in the field of gynecology. However, HIFEM has not yet been rigorously compared to traditional physical therapy for POP. The objectives of this pilot study are to explore clinical effects of HIFEM on POP symptoms; to compare the effectiveness of HIFEM versus PFMT with biofeedback, and usual care on patient-centered outcomes; and to explore the acceptability of the interventions. This is a prospective, single-center randomized controlled trial with a nested qualitative interview study. Twenty-one women with POP, aged \>20 years, will be recruited and randomly allocated to three groups, 'HIFEM' group, 'Biofeedback' group, and 'Usual care' group.The 'HIFEM' group will be asked to sit straight in the center of an electromagnetic chair and remained fully clothed for 28 minutes. The 'Biofeedback' group will receive PFMT with biofeedback and/or electrostimulation. Both 'HIFEM' and 'Biofeedback' groups will receive the interventions twice a week for 8 weeks. Participants allocated to the 'Usual care' group will receive the lifestyle advice leaflet only. All participants will be assessed for pelvic floor muscle function, symptom severity of POP, occurrence and distress related to pelvic floor dysfunction, and impact of pelvic floor dysfunction at baseline and immediately post-intervention.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Kuan-Yin Lin, PhD
kuanyinl27173@ntu.edu.tw
+886-2-33668138
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2026-08-09
Participants
Target number of participants: 28
Treatments
Experimental: HIFEM
During the initial appointment, participants will receive a comprehensive lifestyle advice leaflet covering pertinent information related to POP risk factors and guidance on diet, weight loss, the avoidance of heavy lifting, coughing, high-impact exercises. Following th educational component, participants will be asked to sit in an upright position at the center of an electromagnetic chair (such as the BTL EMSELLA, BTL Industries Inc., Boston MA) while remaining fully clothed for a duration of 28 minutes. To ensure optimal stimulation of the pelvic floor muscles, the physical therapist will carefully monitor the participant's chair posture throughout the treatment sessions and adjust the intensity of the electromagnetic stimulus according to the participant's tolerance threshold.
Active_comparator: Biofeedback
The biofeedback group will undergo PFMT with biofeedback and/or electrostimulation, administered twice a week over 8 weeks by a skilled physical therapist. During the biofeedback and electrical stimulation, participants will assume a supine position with a 45° angle of hip and knee flexion, refraining from actively contracting the PFMs. The intravaginal probe will be inserted into the vagina. The frequency of electrostimulation will be set between 10-50 Hz based on participant tolerance and the pulse duration will be adjusted to 300-500 μs. The stimulation intensity will be set at the maximum tolerable level. During biofeedback, participants will receive visual instructions to guide them in relaxing and contracting their PFMs.
No_intervention: Usual care group
Participants allocated to the usual care (i.e., no physical therapy) group will receive the usual care provided by their obstetricians or gynecologists based on clinical judgment, in addition to the lifestyle advice leaflet provided by the research team. The lifestyle advice leaflet will be given to the participants immediately after the baseline assessment, and the usual care group will have no planned contact with the project staff until 8 weeks after the baseline assessment.
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov