Outpatient rehabilitation versus self-training for postpartum pelvic floor recovery
Prevention of Female Pelvic Floor Dysfunction Rehabilitation Postpartum.
We will test whether supervised outpatient rehab or self-guided home training better prevents and treats pelvic floor problems in women after a singleton childbirth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Vilnius University Academic / other |
| Locations | 1 site (Vilnius) |
| Trial ID | NCT07426770 on ClinicalTrials.gov |
What this trial studies
Participants receive a baseline obstetric and pelvic assessment and then follow either a specialist-led outpatient rehabilitation program or a home self-training program based on specialist recommendations. Objective measures include pelvic organ position (POP-Q), pelvic floor muscle strength and coordination (Oxford Scale and other measures), pelvic/perineal ultrasound, and validated symptom and quality-of-life questionnaires. Examinations occur at about 6–10 weeks postpartum with follow-up assessments at 6 and 12 months to document changes over time. The multidisciplinary team includes an obstetrician-gynecologist, a physical medicine and rehabilitation physician, and a physiotherapist.
Who should consider this trial
Good fit: Women aged 18 or older after a singleton pregnancy who have no contraindications to physical activity and no connective tissue or neurologic disorders are suitable candidates.
Not a fit: Women with multiple gestations, known connective tissue disorders (e.g., Ehlers-Danlos), significant neurologic disease, or other contraindications to exercise are excluded and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, the interventions could reduce postpartum pelvic floor symptoms and improve urinary and sexual function and overall quality of life while informing practical rehabilitation recommendations.
How similar studies have performed: Previous research shows pelvic floor muscle training and specialist-led rehabilitation can improve postpartum urinary incontinence and pelvic floor symptoms, but direct comparisons of supervised outpatient programs versus unsupervised self-training with long-term follow-up remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * This pregnancy was singleton * No contraindications for physical activity * No connective tissue disorders (for example Ehlers-Danlos syndrome) * No neurological disorders to influence pelvic floor symptoms (for example clinically significant spinal disc herniation) Exclusion Criteria: * Younger than 18 years * Twins or triplet pregnancy * Contraindications for physical activity * Connective tissue disorders * Neurological disorders
Where this trial is running
Vilnius
- Vilnius University: study centers: "Vilnius University Hospital " Santaros Clinic", "Vilniaus Gimdymo Namai" — Vilnius, Lithuania (Recruiting)
Study contacts
- Principal investigator: Eglė Pilkionytė, MD — Vilnius University
- Study coordinator: Karolina Eva Romeikiene, Medical doctor, PHD student
- Email: eva.romeikiene@gmail.com
- Phone: +37060406142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.