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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07753746
Acronym
Tele-PFME
Enrollment
45
Registered
2026-08-07
Start date
2024-09-16
Completion date
2026-04-16
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Urinary Incontinence (UI), Childbirth, Tele-rehabilitation

Keywords

pregnancy, pelvic floor exercises, tele-rehabilitation, urinary incontinance

Brief summary

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.

Detailed description

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.

Interventions

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)

OTHERHome based-Non supervised PFME

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)

Sponsors

Artvin Coruh University
Lead SponsorOTHER
Bahçeşehir University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peak Electromyographic (EMG) Amplitude of Pelvic Floor MusclesBefore Intervention, 34-36th weeks of pregnancy, post-natal 6th weekPeak surface EMG amplitude (µV) recorded during maximal voluntary contraction of the pelvic floor muscles, measured using an EMG biofeedback device.
Mean Work and Rest Electromyographic (EMG) Amplitudes of Pelvic Floor MusclesBefore Intervention, 34-36th weeks of pregnancy, post-natal 6th weekMean 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).
Onset Time of Pelvic Floor Muscle ContractionBefore Intervention, 34-36th weeks of pregnancy, post-natal 6th weekTime (second) interval between the verbal contraction cue and the initiation of measurable pelvic floor muscle activity, recorded via surface EMG.
Release Time of Pelvic Floor Muscle ContractionBefore Intervention, 34-36th weeks of pregnancy, post-natal 6th weekTime interval (seconds) between the relaxation cue and complete cessation of measurable pelvic floor muscle activity, recorded via surface EMG.
Percentage of Maximum Voluntary Contraction (%MVC) of Pelvic Floor MusclesBefore Intervention, 34-36th weeks of pregnancy, post-natal 6th weekEMG 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
Pelvic Floor Muscle Displacement by Transabdominal UltrasoundBefore Intervention, 34-36th weeks of pregnancy, post-natal 6th weekTAUS: Displacement/thickness of the pelvic floor muscles measured by transabdominal ultrasound.Unit of measure is centimeter (cm).
Urogenital Distress Inventory-6 (UDI-6)Before Intervention, 34-36th weeks of pregnancy, post-natal 6th weekPatient-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
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)Before Intervention, 34-36th weeks of pregnancy, post-natal 6th weekPatient-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

MeasureTime frameDescription
Duration of the Second Stage of LaborDuring deliveryTime elapsed from full cervical dilation to delivery of the baby. Unit of measure is in minutes
Pain Intensity During Delivery Measured by Visual Analog Scale (VAS)During deliveryPain 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
Birth Weight of the NewbornAt birthWeight of the newborn measured at birth. Unit of measure as grams

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026