Physical Therapy Intervention for Pelvic Organ Prolapses

NCT06532292 | Recruiting

• 1 other identifier: 202401217DINC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• POP symptom severity

  The evaluation of POP symptom severity will utilize the Pelvic Organ Prolapse Symptom Score (POP-SS). The POP-SS comprises seven items gauging the frequency of various prolapse symptoms. Each item employs a five-point Likert scale response set (0-4). The cumulative scores of the seven questions result in a total score ranging from 0 to 28, where higher scores indicate more pronounced symptom severity.

  absolute values at baseline and 8 weeks

Secondary Outcomes (7)

• Distress related to pelvic floor dysfunction

  absolute values at baseline and 8 weeks

• Impact of pelvic floor dysfunction

  absolute values at baseline and 8 weeks

• Pelvic floor muscle strength

  absolute values at baseline and 8 weeks

• Pelvic floor muscle endurance (time)

  absolute values at baseline and 8 weeks

• Pelvic floor muscle endurance (repetition number)

  absolute values at baseline and 8 weeks

Other Outcomes (1)

• Acceptability of the intervention and the outcome measures

  Immediately post-interventions

Study Arms (3)

HIFEM

EXPERIMENTAL

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.

Device: HIFEM

Biofeedback

ACTIVE COMPARATOR

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.

Device: Biofeedback

Usual care group

NO INTERVENTION

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.

Interventions

Biofeedback DEVICE

To facilitate PFM function, electromyography biofeedback and electrical stimulation will be employed using an intravaginal probe, tailored to individual needs.

Biofeedback

HIFEM DEVICE

The HIFEM device (i.e. BTL EMSELLA) is FDA approved and its indications are to provide entirely non-invasive electromagnetic stimulation of pelvic floor muscle for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

HIFEM

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Kuan-Yin Lin, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuan-Yin Lin, PhD

CONTACT

+886-2-33668138; kuanyinl27173@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: August 5, 2024
• Primary Completion: June 6, 2025
• Study Completion (Estimated): August 9, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)