Physical Therapy Intervention for Pelvic Organ Prolapses
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Device: BiofeedbackDevice: HIFEM
- Registration Number
- NCT06532292
- Lead Sponsor
- National Taiwan University Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 21
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biofeedback 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. HIFEM 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.
- Primary Outcome Measures
Name Time Method POP symptom severity absolute values at baseline and 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Pelvic floor muscle endurance (time) absolute values at baseline and 8 weeks Endurance will be measured by asking the participants to sustained an MVC for up to 10 seconds and the sustained time will be recorded in seconds.
Distress related to pelvic floor dysfunction absolute values at baseline and 8 weeks The distress related to pelvic floor dysfunction will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20). This instrument consists of 20 questions in three domains: urinary (6 questions), POP (6 questions), and colorectal-anal (8 questions). The total score ranges from 0 - 300. Higher values indicate greater distress caused by pelvic floor dysfunction.
Impact of pelvic floor dysfunction absolute values at baseline and 8 weeks The impact of pelvic floor dysfunction will be assessed using the Pelvic Floor Impact Questionnaire-7 (PFIQ-7). This questionnaire consists of seven questions in three domains (urinary, POP, and colorectal-anal). The total score ranges from 0 - 300. Higher scores indicate greater impact.
Pelvic floor muscle strength absolute values at baseline and 8 weeks Digital measurement of squeeze and lift strength, recorded using the modified Oxford scale in lying and standing positions will be used. The Modified Oxford Scale quantifies pelvic floor muscle strength as 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong. Maximum voluntary contraction (MVC) strength will be measured over 3 seconds. Participants will need to repeat three MVC contractions, with a 3-second interval in between, and the best of three will be recorded.
Displacement of the bladder neck absolute values at baseline and 8 weeks A real-time transperineal ultrasound, which will be used to measure the displacement of the bladder neck (mm) at rest, during PFM contraction (3 x 3-second contractions), and at maximum Valsalva (forced expiration against a closed glottis, with a relaxed pelvic floor, for at least 6 seconds).
Pelvic floor muscle endurance (repetition number) absolute values at baseline and 8 weeks Endurance will also be measured by asking the participants to perform fast-twitch pelvic floor muscle contractions for up to 10 times with each MVC lasting 1 second. Endurance will be recorded as the number of time of fast contractions that the participant can execute.
Anteroposterior diameter of urogenital hiatus absolute values at baseline and 8 weeks A real-time transperineal ultrasound, which will be used to measure the anteroposterior diameter of urogenital hiatus (mm) at rest, during PFM contraction (3 x 3-second contractions), and at maximum Valsalva (forced expiration against a closed glottis, with a relaxed pelvic floor, for at least 6 seconds).