Pelvic Organ ProlapseNCT06532292
Physical Therapy Intervention for Pelvic Organ Prolapses
A study testing Biofeedback and HIFEM in people with Pelvic Organ Prolapse, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Biofeedback and HIFEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2024to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Biofeedback, HIFEM
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackDevice
To facilitate PFM function, electromyography biofeedback and electrical stimulation will be employed using an intravaginal probe, tailored to individual needs.
HIFEMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: absolute values at baseline and 8 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: absolute values at baseline and 8 weeks
Pelvic Floor Muscle Endurance (Time)
Endurance will be measured by asking the participants to sustained an MVC and the sustained time will be recorded in seconds.
Measured: 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 with each MVC lasting 1 second. Endurance will be recorded as the number of time of fast contractions that the participant can execute.
Measured: absolute values at baseline and 8 weeks
Anteroposterior Diameter of Urogenital Hiatus
A real-time transperineal ultrasound, which will be used to measure changes in the anteroposterior diameter of urogenital hiatus (cm) between rest and PFM contraction.
Measured: absolute values at baseline and 8 weeks
Displacement of the Bladder Neck
A real-time transperineal ultrasound, which will be used to measure changes in the displacement of the bladder neck (cm) between rest and PFM contraction.
Measured: absolute values at baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start5 Aug 2024
- Primary completion6 Jun 2025
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuan-Yin Lin, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532292
- Sponsor's protocol ID
- 202401217DINC
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2024
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The main reason for not sharing individual participant data is that the data are confidential.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy Intervention for Pelvic Organ Prolapses
- ClinicalTrials.gov ID
- NCT06532292
- Acronym / sponsor ID
- 202401217DINC
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIFEM | Experimental | Device: HIFEMDuring 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. |
| Biofeedback | Active comparator | Device: BiofeedbackThe 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (11 listed)
- Stage 4 prolapse
- Tumor in the pelvic region
- A recent surgical procedure (within 6 months)
- Metal implants
- Severe physical/psychiatric impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackTo facilitate PFM function, electromyography biofeedback and electrical stimulation will be employed using an intravaginal probe, tailored to individual needs. | Device | Biofeedback |
| HIFEMThe 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. | Device | HIFEM |
Primary outcome
POP Symptom Severity
Time frame: 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.
7 secondary outcomes
Distress Related to Pelvic Floor Dysfunction
Time frame: absolute values at baseline and 8 weeks
Impact of Pelvic Floor Dysfunction
Time frame: absolute values at baseline and 8 weeks
Pelvic Floor Muscle Strength
Time frame: absolute values at baseline and 8 weeks
Pelvic Floor Muscle Endurance (Time)
Time frame: absolute values at baseline and 8 weeks
Pelvic Floor Muscle Endurance (Repetition Number)
Time frame: absolute values at baseline and 8 weeks
Anteroposterior Diameter of Urogenital Hiatus
Time frame: absolute values at baseline and 8 weeks
Displacement of the Bladder Neck
Time frame: absolute values at baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The main reason for not sharing individual participant data is that the data are confidential.
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuan-Yin Lin, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback and HIFEM in people with Pelvic Organ Prolapse, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POP Symptom Severity (time frame: absolute values at baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.