Postpartum Pelvic Floor Function and SymptomsNCT07228806
Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction at Postpartum Woman
A study testing Pelvic floor exercises with telerehabilitation and Pelvic floor exercises without telerehabilitation in people with Postpartum Pelvic Floor Function and Symptoms, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Pelvic Floor Function and Symptoms
- What is being tested?
- Pelvic floor exercises with telerehabilitation and Pelvic floor exercises without telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2025to 9 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 45
- Primiparous women
- Term vaginal delivery
- 6 weeks postpartum
- Willingness to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
Ayşe Naz Kalem Özgen, +90 0312 797 00 00, kalemnaz@gmail.com
About this study
Official title: 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.
- Being tested
- Pelvic floor exercises with telerehabilitation, Pelvic floor exercises without telerehabilitation
- Keywords
- Postpartum Woman, Pelvic Floor Dysfunction, Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercises with telerehabilitationOther
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.
Pelvic floor exercises without telerehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Not described Receives: Other: Pelvic floor exercises with telerehabilitation |
| Conventional group | Active comparator | Not described Receives: Other: Pelvic floor exercises without telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength assessment
Pelvic floor muscle strength assessment using the SineBravo 2-channel EMG Biofeedback device
Measured: Before exercises programme and 8th week of exercises programme
Secondary outcomes (3)
Measurement of the distance between the inferior edge of the pubic symphysis and the anteromedial edge of the puborectalis muscle using transperineal ultrasound
Measured: Before exercises programme and 8th week of exercises programme
Pelvic floor questionnaire for pregnant and postpartum women
Measured: Before exercises programme and 8th week of exercises programme
Female Sexual Function Index
Measured: Before exercises programme and 8th week of exercises programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start30 Nov 2025
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Pelvic Floor Function and SymptomsStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228806
- Sponsor's protocol ID
- AEŞH-EK-2025-062
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction in Postpartum Women: A Single-Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07228806
- Acronym / sponsor ID
- AEŞH-EK-2025-062
- Keywords
- Postpartum Woman, Pelvic Floor Dysfunction, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 14 Nov 2025 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Other: Pelvic floor exercises with telerehabilitation |
| Conventional group | Active comparator | Other: Pelvic floor exercises without telerehabilitation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 and 45
- Primiparous women
- Term vaginal delivery
- 6 weeks postpartum
- Willingness to participate in the study
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Pelvic floor exercises with telerehabilitationPatients 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. | Other | Telerehabilitation group |
| Pelvic floor exercises without telerehabilitationAn 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. | Other | Conventional group |
Primary outcome
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
3 secondary outcomes
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
Pelvic floor questionnaire for pregnant and postpartum women
Time frame: Before exercises programme and 8th week of exercises programme
Female Sexual Function Index
Time frame: Before exercises programme and 8th week of exercises programme
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exercises with telerehabilitation and Pelvic floor exercises without telerehabilitation in people with Postpartum Pelvic Floor Function and Symptoms, run by Ankara Etlik City Hospital 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Naz Kalem Özgen, specialist (+90 0312 797 00 00, kalemnaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle strength assessment (time frame: Before exercises programme and 8th week of exercises programme). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.