MedTrace Logo

Trial Outcomes & Findings for Physical Therapy Intervention for Pelvic Organ Prolapses (NCT NCT06532292)

NCT ID: NCT06532292

Last Updated: 2026-06-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

absolute values at baseline and 8 weeks

Results posted on

2026-06-12

Participant Flow

Twenty-eight people took part in the study and were divided into three groups: HIFEM (10 participants), PFMT (9 participants), and usual care (9 participants).

Participant milestones

Participant milestones
Measure
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.
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.
Usual Care Group
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.
Overall Study
STARTED
10
9
9
Overall Study
COMPLETED
10
9
6
Overall Study
NOT COMPLETED
0
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Usual Care Group
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.
Overall Study
Lost to Follow-up
0
0
3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Total
n=28 Participants
Total of all reporting groups
Body mass index
23.2 kg/m2
STANDARD_DEVIATION 2.9 • n=10 Participants
23.2 kg/m2
STANDARD_DEVIATION 2.3 • n=9 Participants
26.3 kg/m2
STANDARD_DEVIATION 4.6 • n=9 Participants
23.7 kg/m2
STANDARD_DEVIATION 3.7 • n=28 Participants
Age, Continuous
61.1 year
STANDARD_DEVIATION 7.9 • n=10 Participants
65.6 year
STANDARD_DEVIATION 8.9 • n=9 Participants
63.5 year
STANDARD_DEVIATION 14.8 • n=9 Participants
65.0 year
STANDARD_DEVIATION 10.5 • n=28 Participants
Sex/Gender, Customized
Female
10 Participants
n=10 Participants
9 Participants
n=9 Participants
9 Participants
n=9 Participants
28 Participants
n=28 Participants
Race and Ethnicity Not Collected
—
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Overall POP-Q stage
I
2 Participants
n=10 Participants
2 Participants
n=9 Participants
3 Participants
n=9 Participants
7 Participants
n=28 Participants
Overall POP-Q stage
II
5 Participants
n=10 Participants
3 Participants
n=9 Participants
4 Participants
n=9 Participants
12 Participants
n=28 Participants
Overall POP-Q stage
III
3 Participants
n=10 Participants
4 Participants
n=9 Participants
2 Participants
n=9 Participants
9 Participants
n=28 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
POP Symptom Severity
8 weeks
4 score
Standard Deviation 2.8
6.6 score
Standard Deviation 6.1
7.1 score
Standard Deviation 6.1
POP Symptom Severity
Baseline
9.6 score
Standard Deviation 6.1
8.4 score
Standard Deviation 4.4
7.1 score
Standard Deviation 5.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Distress Related to Pelvic Floor Dysfunction
8 weeks
47.8 score
Standard Deviation 25.2
61.3 score
Standard Deviation 55
59.4 score
Standard Deviation 65.5
Distress Related to Pelvic Floor Dysfunction
Baseline
76.5 score
Standard Deviation 38.7
53.4 score
Standard Deviation 40.2
62.7 score
Standard Deviation 62.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Impact of Pelvic Floor Dysfunction
8 weeks
32.8 score
Standard Deviation 46.6
58.1 score
Standard Deviation 72.9
25.9 score
Standard Deviation 37.9
Impact of Pelvic Floor Dysfunction
Baseline
55.7 score
Standard Deviation 58.8
25.9 score
Standard Deviation 36.2
34.4 score
Standard Deviation 35.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Pelvic Floor Muscle Strength
8 weeks
3.6 score
Standard Deviation 0.7
3.4 score
Standard Deviation 0.5
4.3 score
Standard Deviation 0.5
Pelvic Floor Muscle Strength
Baseline
2.3 score
Standard Deviation 0.7
2.1 score
Standard Deviation 0.7
2.8 score
Standard Deviation 0.5

SECONDARY outcome

Timeframe: absolute values at baseline and 8 weeks

Endurance will be measured by asking the participants to sustained an MVC and the sustained time will be recorded in seconds.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Pelvic Floor Muscle Endurance (Time)
8 weeks
16.4 seconds
Standard Deviation 6
19.4 seconds
Standard Deviation 8.2
32.3 seconds
Standard Deviation 5.6
Pelvic Floor Muscle Endurance (Time)
Baseline
6.2 seconds
Standard Deviation 3.8
9.4 seconds
Standard Deviation 7.3
11.5 seconds
Standard Deviation 7.7

SECONDARY outcome

Timeframe: absolute values at baseline and 8 weeks

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.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Pelvic Floor Muscle Endurance (Repetition Number)
Baseline
10.8 contractions
Standard Deviation 6.2
5.4 contractions
Standard Deviation 3.1
12.0 contractions
Standard Deviation 7.0
Pelvic Floor Muscle Endurance (Repetition Number)
8 weeks
17.9 contractions
Standard Deviation 9.5
11.3 contractions
Standard Deviation 4.5
20.5 contractions
Standard Deviation 6.2

SECONDARY outcome

Timeframe: absolute values at baseline and 8 weeks

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.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Anteroposterior Diameter of Urogenital Hiatus
8 weeks
-0.4 cm
Standard Deviation 0.3
-0.4 cm
Standard Deviation 0.1
-0.4 cm
Standard Deviation 0.3
Anteroposterior Diameter of Urogenital Hiatus
Baseline
-0.2 cm
Standard Deviation 0.1
-0.2 cm
Standard Deviation 0.2
-0.3 cm
Standard Deviation 0.2

SECONDARY outcome

Timeframe: absolute values at baseline and 8 weeks

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.

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Displacement of the Bladder Neck
8 weeks
-1.1 cm
Standard Deviation 0.5
-0.9 cm
Standard Deviation 0.5
-0.7 cm
Standard Deviation 0.4
Displacement of the Bladder Neck
Baseline
-0.7 cm
Standard Deviation 0.5
-0.7 cm
Standard Deviation 0.5
-0.7 cm
Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Number of Participants Considered The Intervention Adequate

Outcome measures

Outcome measures
Measure
HIFEM
n=10 Participants
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.
Biofeedback
n=9 Participants
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.
Usual Care Group
n=9 Participants
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.
Acceptability of the Intervention and the Outcome Measures
10 Participants
9 Participants
6 Participants

Adverse Events

HIFEM

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Biofeedback

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kuan-Yin Lin

National Taiwan University

Phone: +886-2-33668138

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place