Physical Therapy Intervention for Pelvic Organ Prolapses
NCT Number: NCT06532292
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pelvic Organ Prolapse
Interventions: DEVICE: Biofeedback|DEVICE: HIFEM
Sponsor: National Taiwan University Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2025-07-31

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.

Primary Outcome Measures: 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 Outcome Measures: Distress related to pelvic floor dysfunction, 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., absolute values at baseline and 8 weeks|Impact of pelvic floor dysfunction, 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., absolute values at baseline and 8 weeks|Pelvic floor muscle strength, 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., absolute values at baseline and 8 weeks|Pelvic floor muscle endurance (time), 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., absolute values at baseline and 8 weeks|Pelvic floor muscle endurance (repetition number), 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., absolute values at baseline and 8 weeks|Anteroposterior diameter of urogenital hiatus, 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)., absolute values at baseline and 8 weeks|Displacement of the bladder neck, 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)., absolute values at baseline and 8 weeks
Other Outcome Measures: Acceptability of the intervention and the outcome measures, Participants will be invited to participate in interviews about the acceptability of the intervention and the outcome measures. The semi-structured interview guide will guide the exploration of participants' experiences and perspectives on the interventions and outcome measures., Immediately post-interventions