Clinical trial NCT06532292: Physical Therapy Intervention for Pelvic Organ Prolapses
Official title: Physical Therapy Intervention for Pelvic Organ Prolapses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 21
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 daily lives. According to the international guidelines, the management of POP encompasses several approaches, including observation, lifestyle adjustments, pelvic floor muscle training (PFMT), the use of pessaries, reconstructive surgeries, obliterative surgeries, transperineal surgeries, and transabdominal surgeries. Among these, PFMT and pessaries are first-line non-surgical conservative treatments for POP. High-Intensity Focused Electromagnetic Field (HIFEM) is a noninvasive and painless device, designed to promote muscle strengthening and growth. Recently, the HIFEM has become a popular treatment option for urinary incontinence in the field of gynecology. The HIFEM, unlike traditional PFMT, does not require any exposure of the intimate part of the body; the patient is fully clothed and seated on the center of the chair during the treatment. However, while revolutionary, HIFEM has not yet been rigorously compared to traditional physical therapy for POP.

The objectives of this study are:

1. To explore clinical effects of HIFEM on POP symptoms.
2. To compare the effectiveness of HIFEM versus PFMT with biofeedback, and usual care on patient-centered outcomes.
3. To explore the acceptability of the interventions

This is a prospective, single-center randomized controlled trial with a nested qualitative interview study. Sixty-nine 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 process will be supervised by a female physical therapist who will also provide a lifestyle advice leaflet and education to the participants. The training will be provided at a frequency of two sessions per week over 8 weeks. The 'Biofeedback' group will receive PFMT with biofeedback and/or electrostimulation twice a week for 8 weeks with a physical therapist. Participants allocated to the 'Usual care' group will receive the lifestyle advice leaflet only. The baseline and immediately post-intervention assessments will include clinical examination of pelvic floor muscle function (digital palpation and transperineal ultrasound) and three questionnaires about symptom severity of POP, occurrence and distress related to pelvic floor dysfunction, and impact of pelvic floor dysfunction. This study will provide evidence of effectiveness of different modes of physical therapy program for women with POP and health-care professionals working with this population in clinical practice.

Eligibility 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

Primary outcomes:
measure: POP symptom severity
timeFrame: absolute values at baseline and 8 weeks
Secondary outcomes:
measure: Distress related to pelvic floor dysfunction
timeFrame: absolute values at baseline and 8 weeks
measure: Impact of pelvic floor dysfunction
timeFrame: absolute values at baseline and 8 weeks
measure: Pelvic floor muscle strength
timeFrame: absolute values at baseline and 8 weeks
measure: Pelvic floor muscle endurance (time)
timeFrame: absolute values at baseline and 8 weeks
measure: Pelvic floor muscle endurance (repetition number)
timeFrame: absolute values at baseline and 8 weeks
measure: Anteroposterior diameter of urogenital hiatus
timeFrame: absolute values at baseline and 8 weeks
measure: Displacement of the bladder neck
timeFrame: absolute values at baseline and 8 weeks
Other outcomes:
measure: Acceptability of the intervention and the outcome measures
timeFrame: Immediately post-interventions
Locations:
Study officials:
affiliation: National Taiwan University
name: Kuan-Yin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: