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Postpartum Sexual DysfunctionPOSH-ExNCT07747285

POSH-Ex: Physiotherapist-Led Telerehabilitation Exercise Programme for Postpartum Sexual Health

A study testing POSH-Ex (Postpartum Sexual Health Exercise) in people with Postpartum Sexual Dysfunction and Postpartum Depression, run by University Medical Centre Ljubljana at 1 site in Croatia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Postpartum women frequently experience impairments in sexual function, pelvic floor dysfunction, fatigue, and depressive symptoms, all of which may adversely affect their quality of life during the postpartum period. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
POSH-Ex (Postpartum Sexual Health Exercise)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteCroatia
Study dates
1 Sep 2026to 30 Sep 2027
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

  • Women aged 18 to 45 years.
  • Between 10 and 12 weeks postpartum at the time of enrolment.
  • Singleton live birth.
  • Ability to understand and communicate in the Croatian language.
  • Ability to participate safely in moderate-intensity exercise.
  • Access to a computer, tablet, or smartphone with a stable internet connection for participation in online exercise sessions.
  • Willingness to comply with the study protocol and attend supervised exercise sessions.
  • Provision of written informed consent.

Who cannot join

  • • Medical contraindications to exercise according to current clinical recommendations.
  • Pregnancy during the study period.
  • Severe musculoskeletal, neurological, cardiovascular, or other medical conditions preventing safe participation in exercise.
  • Current participation in another structured postpartum rehabilitation or exercise programme.
  • Severe psychiatric disorder requiring immediate specialist treatment.
  • Positive response to Item 10 of the Edinburgh Postnatal Depression Scale indicating current thoughts of self-harm. Such participants will be referred for appropriate clinical assessment before potential study participation.
  • Inability to complete study questionnaires or follow study procedures.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nikolina Zaplatić Degač contact

+385989362968

nzaplatic@unin.hr

Croatia1 site
  • Health Centers of Croatia

    Varaždin, 42000

    Nikolina Zaplatić Degač, +385989362968, nzaplatic@unin.hr

    nzaplatic@unin.hr

Other trials in Croatia

About this study

Official title: POSH-Ex: Randomized Controlled Trial Evaluating a Standardized Physiotherapist-Led Telerehabilitation Programme for Postpartum Sexual Health

Postpartum women frequently experience impairments in sexual function, pelvic floor dysfunction, fatigue, and depressive symptoms, all of which may adversely affect their quality of life during the postpartum period. Although pelvic floor muscle training is recommended as part of postpartum rehabilitation, evidence regarding comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remains limited. Furthermore, no standardized telerehabilitation programme has yet been evaluated using a randomized controlled trial design.

The aim of this randomized controlled trial is to evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized 12-week physiotherapist-led telerehabilitation intervention designed to improve female sexual function and overall postpartum health after childbirth. Secondary objectives are to evaluate its effects on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition.

Read more

A total of 84 postpartum women will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will complete supervised online exercise sessions twice weekly for 12 weeks, while participants in the control group will receive usual postpartum care. Outcome assessments will be performed at baseline and immediately after completion of the intervention.

The primary outcome is female sexual function assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. The findings are expected to provide high-quality evidence regarding the effectiveness of a standardized telerehabilitation programme for postpartum rehabilitation and may contribute to the development of evidence-based postpartum rehabilitation programmes and future clinical practice guidelines.

Read the detailed description

Postpartum sexual health is an important yet frequently neglected component of maternal health. During the postpartum period, women undergo substantial physiological, musculoskeletal, hormonal, and psychosocial changes that may negatively affect sexual function, pelvic floor function, physical activity, psychological well-being, and overall quality of life. Female sexual dysfunction following childbirth is common and is influenced by multiple interrelated factors, including pelvic floor muscle impairment, perineal trauma, fatigue, depressive symptoms, breastfeeding, and reduced physical activity. Despite its high prevalence, postpartum sexual health remains insufficiently addressed within routine postpartum care.

Pelvic floor muscle training is widely recommended for postpartum rehabilitation and has demonstrated beneficial effects on pelvic floor function and urinary continence. However, existing exercise interventions have primarily focused on isolated pelvic floor muscle exercises or single treatment components, while comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remain scarce. Furthermore, the increasing availability of digital health technologies has highlighted the potential of telerehabilitation to improve accessibility and continuity of postpartum physiotherapy services. To the best of our knowledge, no standardized physiotherapist-led telerehabilitation programme specifically developed to improve postpartum sexual health has previously been evaluated in a randomized controlled trial.

The present study will evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized physiotherapist-led telerehabilitation intervention developed to improve female sexual function and overall postpartum health. The programme integrates pelvic floor muscle training with breathing control, deep core muscle activation, functional strengthening exercises, balance training, mobility exercises, and progressive whole-body exercise performed under physiotherapist supervision using an online platform. The intervention has been designed to provide a structured, progressive, and clinically applicable rehabilitation programme suitable for postpartum women.

This study is designed as a parallel-group randomized controlled trial. A total of 84 postpartum women meeting the predefined eligibility criteria will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants allocated to the intervention group will participate in the 12-week POSH-Ex programme consisting of two supervised online exercise sessions per week (60 minutes per session), while participants allocated to the control group will receive usual postpartum care without the structured exercise programme. Participant recruitment will continue until the planned sample size has been achieved and, if necessary, the intervention will be delivered in consecutive cohorts while maintaining identical eligibility criteria, randomization procedures, intervention protocol, supervision procedures, outcome assessment schedule, and data collection methods for all participants.

The primary objective is to determine whether participation in the POSH-Ex programme improves female sexual function compared with usual postpartum care. Female sexual function will be assessed using the Female Sexual Function Index (FSFI). Secondary objectives are to evaluate the effects of the intervention on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. Outcome assessments will be performed at baseline before randomization and immediately following completion of the 12-week intervention.

The study has been designed in accordance with current methodological recommendations for randomized controlled trials. Randomization procedures, participant safety monitoring, adverse event reporting, data management, and statistical analyses have been prospectively defined within the study protocol to ensure methodological rigor, transparency, and reproducibility.

The findings of this trial are expected to provide high-quality evidence regarding the effectiveness of a standardized physiotherapist-led telerehabilitation programme for postpartum rehabilitation. If effective, the POSH-Ex programme may contribute to improving evidence-based physiotherapy practice, facilitate wider implementation of telerehabilitation in postpartum care, and support the development of future clinical guidelines for postpartum rehabilitation and women's health.

Being tested
POSH-Ex (Postpartum Sexual Health Exercise)
Keywords
postpartum, Postpartum rehabilitation, Postpartum sexual health, Female sexual function, Pelvic floor muscle training, Telerehabilitation, Exercise, POSH-Ex
Medical subject headings
Depression, Postpartum, Fatigue, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POSH-Ex (Postpartum Sexual Health Exercise)Behavioural

    POSH-Ex is a standardized physiotherapist-led telerehabilitation programme designed to improve female sexual function and overall postpartum health. The intervention integrates pelvic floor muscle training, breathing control, deep core activation, functional strengthening, balance training, mobility exercises, and progressive whole-body exercises delivered through live online sessions.

Study groups in NCT07747285
Study groupRoleWhat they receive
POSH-Ex (Postpartum Sexual Health Exercise)ExperimentalParticipants allocated to the intervention group will receive the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized physiotherapist-led telerehabilitation intervention delivered over 12 weeks. The programme consists of two supervised online exercise sessions per week (approximately 60 minutes per session) conducted according to a predefined standardized protocol. Participants will additionally receive weekly written exercise materials supporting independent practice between supervised sessions.
Receives: Behavioral: POSH-Ex (Postpartum Sexual Health Exercise)
Control Arm POSH-ExNo interventionParticipants allocated to the control group will receive usual postpartum care routinely available within the Croatian healthcare system. They will not receive the structured POSH-Ex exercise programme during the study period. Outcome assessments will be performed according to the same schedule as in the intervention group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in female sexual function

    Female sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated 19-item self-administered questionnaire evaluating six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Total scores range from 2 to 36, with higher scores indicating better sexual function. The primary outcome will be the change in the total FSFI score from baseline to the end of the 12-week intervention.

    Measured: Baseline and after the 12-weeks

Secondary outcomes (3)
  1. Change in physical activity

    Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Total physical activity and activity by intensity level will be calculated according to the official IPAQ scoring protocol and expressed as MET-minutes per week. The secondary outcome will be the change in physical activity from baseline to the end of the intervention.

    Measured: Baseline and after the 12-weeks

  2. Change in fatigue

    Fatigue will be assessed using the Fatigue Assessment Scale (FAS), a validated 10-item questionnaire measuring physical and mental fatigue. Total scores range from 10 to 50, with higher scores indicating greater fatigue. The secondary outcome will be the change in fatigue scores from baseline to the end of the intervention.

    Measured: Baseline and after the 12-weeks

  3. Change in depressive symptoms

    Depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a validated 10-item questionnaire designed to screen for postpartum depressive symptoms. Higher scores indicate greater severity of depressive symptoms. The secondary outcome will be the change in EPDS scores from baseline to the end of the intervention.

    Measured: Baseline and after the 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to either the experimental group receiving the POSH-Ex (Postpartum Sexual Health Exercise) programme or the control group receiving usual postpartum care. The study uses a parallel-group design in which participants remain in their allocated group throughout the 12-week intervention period. Outcome assessments will be performed at baseline and immediately after completion of the intervention. If necessary, participant recruitment and intervention delivery will be conducted in consecutive cohorts while maintaining identical eligibility criteria, randomization procedures, intervention protocols, outcome assessment schedules, and data collection methods across all cohorts.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07747285
Sponsor's protocol ID
POSH-EX-2026-01
Acronym
POSH-Ex
Status last verified
Jul 2026
First submitted
30 Jul 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Degac NZ, Zivoder I, Bogataj S. The POSH-Ex Study: Study Protocol for a Randomized Controlled Trial of a 12-Week Online Physiotherapy Intervention for Improving Postpartum Sexual Health. Healthcare (Basel). 2026 Oct 2;14(19):3277. doi: 10.3390/healthcare14193277.

    PubMed 42881716

Questions about this trial

What is this clinical trial studying?

A study testing POSH-Ex (Postpartum Sexual Health Exercise) in people with Postpartum Sexual Dysfunction and Postpartum Depression, run by University Medical Centre Ljubljana at 1 site in Croatia.

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 8 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: opening soon, as of the sponsor's last update on 5 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 Croatia. 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 Nikolina Zaplatić Degač (+385989362968, nzaplatic@unin.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in female sexual function (time frame: Baseline and after the 12-weeks). 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 NCT07747285, which also lists 1 linked publication.

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 5 Aug 2026.

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