Study Comparing Specialist-led Rehabilitation and Self-training for Preventing and Treating Pelvic Floor Dysfunction After Childbirth in Women Aged 18 to 50
Led by Vilnius University · Updated on 2026-02-23
80
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare the effects of specialist-supported rehabilitation versus self-training on preventing and treating pelvic floor dysfunction in women during the postpartum period. The study evaluates changes in pelvic organ position, pelvic floor muscle function, symptoms of pelvic floor dysfunction, and how these symptoms affect quality of life. Participants are women who are 6 to 10 weeks postpartum and will be assessed with various validated questionnaires and objective tests.
Participants are divided into two groups one group receives supervised physiotherapy, biofeedback, and transcutaneous electrical nerve stimulation TENS treatments led by specialists, including a physical medicine and rehabilitation doctor and a physiotherapist. The other group follows a self-training program at home based on specialist instructions, using a mobile app called squeezy to remind and record training sessions. The study includes assessments before training, after six months of training, and after twelve months.
Women in the study will have medical examinations, pelvic floor muscle assessments, ultrasound scans, and complete questionnaires that cover urinary incontinence, prolapse symptoms, sexual function, and overall quality of life. Researchers will track pelvic floor muscle strength and coordination, pelvic organ position, pain levels, and muscle activity over time. The study also monitors factors such as birth history and body measurements that may affect rehabilitation outcomes. Participation lasts for at least one year with evaluations at key intervals.
CONDITIONS
Brief Title
Comparison of Outpatient Rehabilitation Versus Self-training for the Treatment and Prevention of Postpartum Pelvic Floor Dysfunction
Research Team
K
Karolina Eva Romeikiene, Medical doctor, PHD student
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Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Rehabilitation Postpartum
Duration - Approximately 6 months
Participants start a supervised training program with physiotherapist and physical medicine and rehabilitation physician including biofeedback training, physiotherapy, and electrostimulation.
Multiple visits for up to 6 months
Self-training Postpartum
Duration - Approximately 6 months
Participants perform self-training at home after receiving instructions, using an app to record training frequency and duration.
Ongoing self-training with app monitoring for up to 6 months
Follow-up Assessments
Duration - 6 months
Participants are assessed at 6 and 12 months after beginning training to evaluate changes in pelvic floor muscle strength, pelvic floor dysfunction symptoms, and quality of life.
2 visits (at 6 months and 12 months post training start)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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