Clinical Trial

Comparison of Outpatient Rehabilitation Versus Self-training for the Treatment and Prevention of Postpartum Pelvic Floor Dysfunction

Study acronym: DDDPREV
Recruiting
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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).
Trial Details
NCT Number NCT07426770
Lead Sponsor Vilnius University
Collaborators: Vilnius University Hospital Santaros Klinikos, Vilnius Maternity Hospital
Conditions Pelvic Floor Dysfunction, Postpartum Care, Postpartum Comfort, Female Urinary Incontinence and Pelvic Organ Prolapse, Rectus Diastasis, Sexual Dysfunction Female
Enrollment 80 participants
Start Date 2024-01-30
Primary Completion 2027-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-23