- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228806
Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction at Postpartum Woman
February 22, 2026 updated by: Ayse Naz Kalem, Ankara Etlik City Hospital
Evaluation of the Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction in Postpartum Women: A Single-Blind Randomised Controlled Trial
These events are largely due to pelvic floor dysfunction that develops after pregnancy.
Kegel exercises and core stabilisation exercises performed in the postpartum period are important in preventing pelvic floor dysfunction.
However, considering the mother's adaptation process to both the baby and her new life in the postpartum period, there may be problems with exercise compliance.
Increasing exercise compliance through telerehabilitation can be effective in preventing pelvic floor dysfunction and improving women's quality of life.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayse Naz Kalem Ozgen, Specialist
- Phone Number: +90 0312 797 00 00
- Email: kalemnaz@gmail.com
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06010
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Ayşe Naz Kalem Özgen
- Phone Number: +90 0312 797 00 00
- Email: kalemnaz@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged between 18 and 45
- Primiparous women
- Term vaginal delivery
- 6 weeks postpartum
- Willingness to participate in the study
Exclusion Criteria:
- Presence of faecal or urinary incontinence prior to pregnancy
- Use of assisted delivery devices (vacuum, forceps)
- Presence of neurological disease
- Presence of psychiatric illness or cognitive problems that make it difficult to answer questions
- Caesarean section delivery
- History of diabetes mellitus
- Perineal rupture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation group
|
Patients in the telerehabilitation group will be assigned the same 8-week exercise programme as those in the conventional group to be carried out at home.
Unlike the conventional group, patients in the telerehabilitation group will be contacted by telephone each week throughout the exercise programme to check their adherence to the programme, to ask if they have encountered any problems with the exercise programme, and to answer any questions they may have.
|
|
Active Comparator: Conventional group
|
An 8-week exercise programme consisting of 45-minute Kegel exercises and core stabilisation exercises per day will be provided for implementation at home in the conventional group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic floor muscle strength assessment
Time Frame: Before exercises programme and 8th week of exercises programme
|
Pelvic floor muscle strength assessment using the SineBravo 2-channel EMG Biofeedback device
|
Before exercises programme and 8th week of exercises programme
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of the distance between the inferior edge of the pubic symphysis and the anteromedial edge of the puborectalis muscle using transperineal ultrasound
Time Frame: Before exercises programme and 8th week of exercises programme
|
Before exercises programme and 8th week of exercises programme
|
|
Pelvic floor questionnaire for pregnant and postpartum women
Time Frame: Before exercises programme and 8th week of exercises programme
|
Before exercises programme and 8th week of exercises programme
|
|
Female Sexual Function Index
Time Frame: Before exercises programme and 8th week of exercises programme
|
Before exercises programme and 8th week of exercises programme
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2025
Primary Completion (Estimated)
May 9, 2026
Study Completion (Estimated)
May 9, 2026
Study Registration Dates
First Submitted
November 13, 2025
First Submitted That Met QC Criteria
November 13, 2025
First Posted (Actual)
November 14, 2025
Study Record Updates
Last Update Posted (Actual)
February 24, 2026
Last Update Submitted That Met QC Criteria
February 22, 2026
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK-2025-062
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Pelvic floor exercises with telerehabilitation
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eman elhosaryUnknownStress Urinary Incontinence
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Centro Hospitalar De São João, E.P.E.CompletedCovid19 | Stress Urinary Incontinence | Pelvic Floor Muscle Weakness | Incontinence, UrinaryPortugal
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