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Completed

NCT Number: NCT07753746

Effects Of Tele-PFME On Urinary Incontinance, Pelvıc Floor Functions and Childbirth

The aim of this study is to examine the effect of pelvic floor exercises performed via prenatal tele-rehabilitation on the following issues:

1. Perceived symptom severity and frequency associated with the development of urinary incontinence and quality of life 2. Pelvic floor muscle function and 3. Birth and delivery parameters in pregnant women. Research Questions

1. Does prenatal tele-pelvic floor exercise reduce the frequency or symptom severity of urinary incontinence in the late stages of pregnancy and the early postpartum period? 2. Does prenatal tele-pelvic floor exercise improve pelvic floor muscle function and contraction performance? 3. Does prenatal tele-pelvic floor exercise affect delivery parameters such as labor duration, mode of delivery, episiotomy, and perineal trauma? The current literature indicates that prenatal tele-pelvic floor exercise can reduce the risk of urinary incontinence during pregnancy and the postpartum period by preserving pelvic floor muscle function in pregnant women, and recommends the application of pelvic floor muscle exercises and pelvic floor training during pregnancy due to their protective effect. However, more data are needed to draw meaningful conclusions about the participation (continuity) of PTKE in treatment, how and by whom it is administered, and its effects on postnatal UI. In addition to preventing UI, studies are needed that more clearly express the effects of antenatal PTKE, such as improved quality of life specific to UI with a reduction in the severity, frequency, and amount of leakage, and the determination of changes in pelvic floor muscle strength and function in the long term. There are studies that mention various content regarding education and exercise practices. With the Covid-19 conditions, the way healthcare institutions operate has been visibly affected. Based on this, potential situations such as individuals not being able to benefit sufficiently from healthcare facilities may occur. Investigators believe that tele-rehabilitation methods will provide us with positive support in this regard, in terms of reaching individuals and providing healthcare services to individuals during the thesis study. Furthermore, more studies are needed on the effects of PTKE programs conducted through tele-health applications on treatment participation, patient adherence to treatment, and prenatal/postnatal urinary tract infection.

Evidence from research on application/tele-rehabilitation-based pelvic floor muscle exercises in women during pregnancy and the postnatal period shows potential benefits in terms of adherence and symptom management, but the literature is less mature than the literature on general pelvic floor muscle exercises. The aim of this study is to investigate the effectiveness of a tele-rehabilitation-supervised pelvic floor muscle exercise program (PFME) in preventing urinary incontinence during pregnancy and postpartum, and its effects on pelvic floor function, strength, and delivery parameters.

Hypotheses H0 (primary): In pregnant women, a structured tele-rehabilitation-based pelvic floor muscle exercise (PFME) program does not differ from a home exercise program in terms of its effect on urinary incontinence symptoms in the late pregnancy and early postpartum period.

H1 (primary): In pregnant women, a structured tele-rehabilitation-based PFME program reduces urinary incontinence symptoms in the late pregnancy and early postpartum period compared to a home exercise program.

H0 (primary): In pregnant women, a structured tele-rehabilitation-based pelvic floor muscle exercise (PFME) program does not differ from a home exercise program in terms of its effect on pelvic floor muscle function in the late pregnancy and early postpartum period.

H 2 (primary): In pregnant women, a structured tele-rehabilitation-based PFME program improves pelvic floor muscle function in late pregnancy and early postpartum compared to a PFME program given as a home exercise program.

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Key information

About this study

Pregnancy and childbirth are significant risk factors for urinary incontinence (UI); mechanical and hormonal changes, increased intra-abdominal pressure, and pregnancy-related changes in pelvic floor tissues and nerves, vaginal delivery, and obstetric anal sphincter injury increase the risk of developing UI, while cesarean delivery reduces the short-term postpartum UI risk. Stress incontinence may also be linked to hormones such as relaxin and progesterone during pregnancy.

The prevalence of UI reported personally during the prenatal period is being widely investigated. Figures indicating UI prevalence vary greatly in published reports depending on the case definitions applied, the population recruited, and the study methodology (9-63%).

Urinary incontinence is a common problem among adults living in the community. It is more frequent in women, and pregnancy or the postpartum period may be the first time many women experience UI. Stress urinary incontinence (involuntary urine leakage with physical exertion) and urge incontinence (involuntary urine leakage associated with or immediately following a sudden need to urinate) are the two most common types of urinary incontinence in women. Many women experience symptoms of both stress and urge incontinence; this is called mixed type UI. Of these types, stress urinary incontinence is most commonly associated with pregnancy and the postpartum period.

The degree of discomfort experienced by pregnant women regarding UI varies. Since the degree of discomfort or severity of UI, or the prevalence of urge incontinence, can overestimate the actual prevalence, (high) prevalence rates should be interpreted cautiously when case definitions do not include a measure of symptom discomfort. Therefore, the International Incontinence Consultation (ICI) recommends adding a measure of discomfort to prevalence figures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single pregnancy
  • BMI < 30 kg/m^2
  • Being between 18-35 years old

Exclusion criteria

  • Women with risk of abortion
  • Women with serious lung diseases (COPD, asthma, etc.)
  • Women with gestational diabetes
  • Women with high-risk pregnancies (gestational diabetes, preeclampsia, bleeding, severe anemia, cervical insufficiency, trauma, etc.)
  • Women with multiple pregnancies
  • Women with a BMI above 30 kg/m^2 and below 20 kg/m^2 during pregnancy
  • Women undergoing infertility treatment
  • Women whose height is less than 150 cm
  • Women who regularly exercise during pregnancy
  • Women who do not continue exercise for more than 4 weeks

Treatment and study plan

Tele-rehabilitation

Other

Pelvic Floor Muscle Exercises program:

It is specially planned according to the individual's muscle strength. (Sample progress below.) In tele-PFME group exercises will supervised by physiotherapist via video conference.

Week 1: 5x(10 taps +10 lifts) Week 2: 10x(10 taps +10 lifts) Week 3: 15x(10 taps +10 lifts) Week 4: 20x(10 taps +10 lifts) Week 5: 25x(10 taps +10 lifts) Week 6: 30x(10 taps +10 lifts) Week 7: 10x (10 taps + 5 lifts) + 10x (10 taps + 10 lifts)

Home based-Non supervised PFME

Other

Pelvic Floor Muscle Exercises program:

It is specially planned according to the individual's muscle strength. (Sample progress below.). The PFME program was provided in writing, and adherence to the exercise program was monitored weekly using a tracking chart. Participants performed the exercises according to the written program. They did not receive supervision or corrective instructions regarding the exercises.

Week 1: 5x(10 taps +10 lifts) Week 2: 10x(10 taps +10 lifts) Week 3: 15x(10 taps +10 lifts) Week 4: 20x(10 taps +10 lifts) Week 5: 25x(10 taps +10 lifts) Week 6: 30x(10 taps +10 lifts) Week 7: 10x (10 taps + 5 lifts) + 10x (10 taps + 10 lifts)

Primary outcomes

  1. Peak Electromyographic (EMG) Amplitude of Pelvic Floor Muscles

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    Peak surface EMG amplitude (µV) recorded during maximal voluntary contraction of the pelvic floor muscles, measured using an EMG biofeedback device.

  2. Mean Work and Rest Electromyographic (EMG) Amplitudes of Pelvic Floor Muscles

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    Mean surface EMG amplitude recorded during sustained voluntary contraction and resting of the pelvic floor muscles, measured using an EMG biofeedback device.Unit of measure is microvolt (µV).

  3. Onset Time of Pelvic Floor Muscle Contraction

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    Time (second) interval between the verbal contraction cue and the initiation of measurable pelvic floor muscle activity, recorded via surface EMG.

  4. Release Time of Pelvic Floor Muscle Contraction

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    Time interval (seconds) between the relaxation cue and complete cessation of measurable pelvic floor muscle activity, recorded via surface EMG.

  5. Percentage of Maximum Voluntary Contraction (%MVC) of Pelvic Floor Muscles

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    EMG amplitude during contraction expressed as a percentage of the maximum voluntary contraction amplitude, reflecting relative muscle activation.Unit of measure is percentage of maximum voluntary contraction (%MVC). It evaluated during Work and Rest

  6. Pelvic Floor Muscle Displacement by Transabdominal Ultrasound

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    TAUS: Displacement/thickness of the pelvic floor muscles measured by transabdominal ultrasound.Unit of measure is centimeter (cm).

  7. Urogenital Distress Inventory-6 (UDI-6)

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    Patient-reported urogenital symptom distress assessed using the UDI-6 questionnaire. Scores range from 0 to 100, with higher scores indicating greater distress. Unit of measure is score on a scale

  8. International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week

    Patient-reported urinary incontinence severity assessed using the ICIQ-UI SF questionnaire. Scores range from 0 to 21, with higher scores indicating greater severity of urinary incontinence. Unit os measure is score on a scale.

Secondary outcomes

  1. Duration of the Second Stage of Labor

    Time frame: During delivery

    Time elapsed from full cervical dilation to delivery of the baby. Unit of measure is in minutes

  2. Pain Intensity During Delivery Measured by Visual Analog Scale (VAS)

    Time frame: During delivery

    Pain intensity during delivery assessed using the Visual Analog Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Unit of measure is score on a scale

  3. Birth Weight of the Newborn

    Time frame: At birth

    Weight of the newborn measured at birth. Unit of measure as grams

Other outcomes

  1. Categorical: Mode of Delivery

    Time frame: At delivery

    Number of participants who delivered vaginally versus by cesarean section. Unit of measure is participants number

    Categories are:

    • Vaginal birth
    • Cesarean section
  2. Categorical: Incidence of Episiotomy

    Time frame: At delivery

    Number of participants who underwent episiotomy during delivery. Unit of measure is participants

  3. Categorical: Incidence of Perineal Laceration

    Time frame: At delivery

    Number of participants who experienced perineal laceration during delivery. Unit of measure is participants

Sponsors and collaborators

Lead sponsor

Artvin Coruh University

Other

Collaborators

  • Bahçeşehir University

Registry information

Official study title

Effects Of Telerehabilitation-Based Pelvıc Floor Muscle Exercises On Urinary Incontinance, Pelvic Floor Functions and Childbirth In Pregnant Women

Acronym: Tele-PFME

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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