NCT07426770 Comparison of Outpatient Rehabilitation Versus Self-training for the Treatment and Prevention of Postpartum Pelvic Floor Dysfunction
| NCT ID | NCT07426770 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vilnius University |
| Condition | Pelvic Floor Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-01-30 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main goal of this study to compare self-training postpartum and training with a specialist support (physiotherapist and physical medicine and rehabilitation doctor) effect on pelvic floor dysfunction prevention and treatment in postpartum period. Hypothesis: The implementation of postpartum rehabilitation helps to alleviate existing symptoms of pelvic floor dysfunction and prevents pelvic floor dysfunction. Study goals: * To objectively evaluate changes in pelvic organ position and pelvic floor muscle function in postpartum period, before and after specialised rehabilitation program * To objectively evaluate pelvic floor symptoms and their influence on woman life quality * To compare data (changes in pelvic floor muscle coordination and strength, pelvic organ position and changes in life quality according to validated questionnaires) Study participants will: * Get an examination by obstetrician-gynaecologist, physical medicine and rehabilitation doctor and physiotherapist in 6 to 10 weeks postpartum period. * One group of participants will attend physiotherapy, biofeedback and electro stimulation procedures with a guidance of a specialist. * Other group of participants gets a recommendations and instructions of training and self-trains at home. To remind of training and help record training time "squeezy" app (an application designed for a mobile device) will be offered. * All groups of participants will be asked to fill life quality related questionnaires: (ICIQ-UI SF: International Consultation on Incontinence Questionnaire; P-QoL: Prolapse Quality-of-Life Questionnaire; PISQ-IR: Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire IUGA revised; FSFI: female sexual function index; MOS-SF36 Medical Outcomes Study Short Form-36).
Eligibility 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
Contact & Investigator
Lina Būtėnaitė, MD, PhD
STUDY CHAIR
Vilnius University
Frequently Asked Questions
Who can join the NCT07426770 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Pelvic Floor Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07426770 currently recruiting?
Yes, NCT07426770 is actively recruiting participants. Contact the research team at eva.romeikiene@gmail.com for enrollment information.
Where is the NCT07426770 trial being conducted?
This trial is being conducted at Vilnius, Lithuania.
Who is sponsoring the NCT07426770 clinical trial?
NCT07426770 is sponsored by Vilnius University. The principal investigator is Lina Būtėnaitė, MD, PhD at Vilnius University. The trial plans to enroll 80 participants.