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

NCT07753746 | Completed

• 1 other identifier: 2024/23
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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.

  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).

  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.

  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.

  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

  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).

  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

  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.

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

Secondary Outcomes (3)

• Duration of the Second Stage of Labor

  During delivery

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

  During delivery

• Birth Weight of the Newborn

  At birth

Other Outcomes (3)

• Categorical: Mode of Delivery

  At delivery

• Categorical: Incidence of Episiotomy

  At delivery

• Categorical: Incidence of Perineal Laceration

  At delivery

Study Arms (2)

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)

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.

Other: Home based-Non supervised PFME

Interventions

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)

Intervention (tele-PFME)

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)

Control(Home based, none supervised)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Artvin Coruh University: lead
• Bahçeşehir University: collaborator

Study Sites (1)

ClinicHİSS Opr. Dr. Hilal Sakallıoğlu

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 33125272 BACKGROUND

• Alouini 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.

  PMID: 35270480 BACKGROUND

• Bokne 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.

  PMID: 31317808 BACKGROUND

• Trowbridge 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.

  PMID: 35135660 BACKGROUND

• Woodley 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.

  PMID: 33950309 BACKGROUND

• Woodley 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.

  PMID: 32378735 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate student

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: August 7, 2026
• Study Start: September 16, 2024
• Primary Completion: January 2, 2026
• Study Completion: April 16, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-07

Locations

TU (1)