PregnancyTele-PFMENCT07753746
Effects Of Tele-PFME On Urinary Incontinance, Pelvıc Floor Functions and Childbirth
A study testing Tele-rehabilitation and Home based-Non supervised PFME in people with Pregnancy and Urinary Incontinence (UI), run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Urinary Incontinence (UI), Childbirth
- What is being tested?
- Tele-rehabilitation and Home based-Non supervised PFME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2024to 16 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single pregnancy
- BMI < 30 kg/m^2
- Being between 18-35 years old
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
ClinicHİSS Opr. Dr. Hilal Sakallıoğlu
Kahramanmaraş, 46100
About this study
Official title: Effects Of Telerehabilitation-Based Pelvıc Floor Muscle Exercises On Urinary Incontinance, Pelvic Floor Functions and Childbirth In Pregnant Women
The aim of this study is to examine the effect of pelvic floor exercises performed via prenatal tele-rehabilitation on the following issues:
- Perceived symptom severity and frequency associated with the development of urinary incontinence and quality of life
- Pelvic floor muscle function and
- Birth and delivery parameters in pregnant women. Research Questions
- 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.
Read more
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.
Read the 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.
- Conditions
- Pregnancy, Urinary Incontinence (UI), Childbirth, Tele-rehabilitation
- Being tested
- Tele-rehabilitation, Home based-Non supervised PFME
- Keywords
- pregnancy, pelvic floor exercises, tele-rehabilitation, urinary incontinance
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitationOther
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 PFMEOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention (tele-PFME) | Experimental | In the Tele-PFME group, exercises were performed 3 days a week under video call supervision (correct use of the diaphragm and breathing and positions were checked during the exercises). Participation and continuity of the exercise program, which was implemented via teleconference with a physiotherapist in individual programs based on the PFME group training program, were recorded by the physiotherapist.
Pelvic Floor Muscle Exercises program:
It is specially planned according to the individual's muscle strength. (Sample progress below.) 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) Receives: Other: Tele-rehabilitation |
| Control(Home based, none supervised) | Other | Control (home exercise) group. In the control (home exercise) group, since PFME is routinely used in many pelvic floor studies and in the clinic, the patient was taught the exercise routine and the weekly program given in writing was followed up by calling every two weeks. In both groups, patients who did not continue the exercise program at least two days a week for more than four weeks were excluded from the study. Otherwise, the study would have remained as an educational study only, with the control group against the tele-PFME group. Receives: Other: Home based-Non supervised PFME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Electromyographic (EMG) Amplitude of Pelvic Floor Muscles
Peak surface EMG amplitude (µV) recorded during maximal voluntary contraction of the pelvic floor muscles, measured using an EMG biofeedback device.
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
Mean Work and Rest Electromyographic (EMG) Amplitudes of Pelvic Floor Muscles
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).
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
Onset Time of Pelvic Floor Muscle Contraction
Time (second) interval between the verbal contraction cue and the initiation of measurable pelvic floor muscle activity, recorded via surface EMG.
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
Release Time of Pelvic Floor Muscle Contraction
Time interval (seconds) between the relaxation cue and complete cessation of measurable pelvic floor muscle activity, recorded via surface EMG.
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
Percentage of Maximum Voluntary Contraction (%MVC) of Pelvic Floor Muscles
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
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
Pelvic Floor Muscle Displacement by Transabdominal Ultrasound
TAUS: Displacement/thickness of the pelvic floor muscles measured by transabdominal ultrasound.Unit of measure is centimeter (cm).
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
Urogenital Distress Inventory-6 (UDI-6)
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
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
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.
Measured: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week
Secondary outcomes (3)
Duration of the Second Stage of Labor
Time elapsed from full cervical dilation to delivery of the baby. Unit of measure is in minutes
Measured: During delivery
Pain Intensity During Delivery Measured by Visual Analog Scale (VAS)
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
Measured: During delivery
Birth Weight of the Newborn
Weight of the newborn measured at birth. Unit of measure as grams
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start16 Sep 2024
- Primary completion2 Jan 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Principal investigator, Mehlika Alatas, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753746
- Sponsor's protocol ID
- 2024/23
- Acronym
- Tele-PFME
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kucukkaya B, Kahyaoglu Sut H. Effectiveness of pelvic floor muscle and abdominal training in women with stress urinary incontinence. Psychol Health Med. 2021 Jul;26(6):779-786. doi: 10.1080/13548506.2020.1842470. Epub 2020 Oct 30.
PubMed 33125272Alouini S, Memic S, Couillandre A. Pelvic Floor Muscle Training for Urinary Incontinence with or without Biofeedback or Electrostimulation in Women: A Systematic Review. Int J Environ Res Public Health. 2022 Feb 27;19(5):2789. doi: 10.3390/ijerph19052789.
PubMed 35270480Bokne K, Sjostrom M, Samuelsson E. Self-management of stress urinary incontinence: effectiveness of two treatment programmes focused on pelvic floor muscle training, one booklet and one Internet-based. Scand J Prim Health Care. 2019 Sep;37(3):380-387. doi: 10.1080/02813432.2019.1640921. Epub 2019 Jul 18.
PubMed 31317808Trowbridge ER, Hoover EF. Evaluation and Treatment of Urinary Incontinence in Women. Gastroenterol Clin North Am. 2022 Mar;51(1):157-175. doi: 10.1016/j.gtc.2021.10.010. Epub 2022 Jan 7.
PubMed 35135660Woodley SJ, Hay-Smith EJC. Narrative review of pelvic floor muscle training for childbearing women-why, when, what, and how. Int Urogynecol J. 2021 Jul;32(7):1977-1988. doi: 10.1007/s00192-021-04804-z. Epub 2021 May 5.
PubMed 33950309Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
PubMed 32378735
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Telerehabilitation-Based Pelvıc Floor Muscle Exercises On Urinary Incontinance, Pelvic Floor Functions and Childbirth In Pregnant Women
- ClinicalTrials.gov ID
- NCT07753746
- Acronym / sponsor ID
- Tele-PFME / 2024/23
- Conditions
- Pregnancy, Urinary Incontinence (UI), Childbirth, Tele-rehabilitation
- Keywords
- pregnancy, pelvic floor exercises, tele-rehabilitation, urinary incontinance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effect of pelvic floor exercises performed via prenatal tele-rehabilitation on the following issues:
- Perceived symptom severity and frequency associated with the development of urinary incontinence and quality of life
- Pelvic floor muscle function and
- Birth and delivery parameters in pregnant women. Research Questions
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (tele-PFME) | Experimental | Other: Tele-rehabilitationIn the Tele-PFME group, exercises were performed 3 days a week under video call supervision (correct use of the diaphragm and breathing and positions were checked during the exercises). Participation and continuity of the exercise program, which was implemented via teleconference with a physiotherapist in individual programs based on the PFME group training program, were recorded by the physiotherapist. Pelvic Floor Muscle Exercises program: It is specially planned according to the individual's muscle strength. (Sample progress below.) 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) |
| Control(Home based, none supervised) | Other | Other: Home based-Non supervised PFMEControl (home exercise) group. In the control (home exercise) group, since PFME is routinely used in many pelvic floor studies and in the clinic, the patient was taught the exercise routine and the weekly program given in writing was followed up by calling every two weeks. In both groups, patients who did not continue the exercise program at least two days a week for more than four weeks were excluded from the study. Otherwise, the study would have remained as an educational study only, with the control group against the tele-PFME group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Single pregnancy
- BMI < 30 kg/m^2
- Being between 18-35 years old
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Tele-rehabilitationPelvic 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) | Other | Intervention (tele-PFME) |
| Home based-Non supervised PFMEPelvic 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) | Other | Control(Home based, none supervised) |
Primary outcome
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.
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).
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.
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.
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
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).
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
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.
3 secondary outcomes
Duration of the Second Stage of Labor
Time frame: During delivery
Pain Intensity During Delivery Measured by Visual Analog Scale (VAS)
Time frame: During delivery
Birth Weight of the Newborn
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 33125272Kucukkaya B, Kahyaoglu Sut H. Effectiveness of pelvic floor muscle and abdominal training in women with stress urinary incontinence. Psychol Health Med. 2021 Jul;26(6):779-786. doi: 10.1080/13548506.2020.1842470. Epub 2020 Oct 30.
- Background: PubMed 35270480Alouini S, Memic S, Couillandre A. Pelvic Floor Muscle Training for Urinary Incontinence with or without Biofeedback or Electrostimulation in Women: A Systematic Review. Int J Environ Res Public Health. 2022 Feb 27;19(5):2789. doi: 10.3390/ijerph19052789.
- Background: PubMed 31317808Bokne K, Sjostrom M, Samuelsson E. Self-management of stress urinary incontinence: effectiveness of two treatment programmes focused on pelvic floor muscle training, one booklet and one Internet-based. Scand J Prim Health Care. 2019 Sep;37(3):380-387. doi: 10.1080/02813432.2019.1640921. Epub 2019 Jul 18.
- Background: PubMed 35135660Trowbridge ER, Hoover EF. Evaluation and Treatment of Urinary Incontinence in Women. Gastroenterol Clin North Am. 2022 Mar;51(1):157-175. doi: 10.1016/j.gtc.2021.10.010. Epub 2022 Jan 7.
- Background: PubMed 33950309Woodley SJ, Hay-Smith EJC. Narrative review of pelvic floor muscle training for childbearing women-why, when, what, and how. Int Urogynecol J. 2021 Jul;32(7):1977-1988. doi: 10.1007/s00192-021-04804-z. Epub 2021 May 5.
- Background: PubMed 32378735Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation and Home based-Non supervised PFME in people with Pregnancy and Urinary Incontinence (UI), run by Artvin Coruh University at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 7 Aug 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak Electromyographic (EMG) Amplitude of Pelvic Floor Muscles (time frame: Before Intervention, 34-36th weeks of pregnancy, post-natal 6th week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07753746, which also lists 6 linked publications.
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 7 Aug 2026.