About this trial
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
This trial accepts healthy volunteersQualifiers
18 years or older
This pregnancy was singleton
No contraindications for physical activity
No connective tissue disorders (for example Ehlers-Danlos syndrome)
Disqualifiers
Younger than 18 years
Twins or triplet pregnancy
Contraindications for physical activity
Connective tissue disorders
Trial design
Parallel
Treatments tested in this trial
Rehabilitation postpartum
Behavioral* 4 Times biofeedback training * 10 times physiotherapy with specialist * 10 times transcutaneal electrostimulation (TENS)
Self-training
Behavioral* training at home after physiotherapist instructions * using an app to record training frequency, length
Treatment groups
Trial outcomes
Primary outcomes
Improvement in pelvic floor dysfunction symptoms
Self-reported improvement of symptoms (for example: pain, urinary incontinence, fecal incontinence, vaginal "laxity")
Change in PFM contraction force and strength according to the Modified Oxford Scale
Individual change in Oxford scores (0-5), bigger number means stronger contraction.
Change in POP-Q scale
changes in POP-Q scales (especially in gh - genital hiatus, pb - perineal body, measured by centimeters, bigger number in gh means wider genital hiatus -worse outcome; smaller number in pb means thin perineal body - worse outcome)
Change in life quality questionnaires ICIQ-UI SF
Quality of Life (QoL) and clinical outcome questionnaires: \* ICIQ-UI SF (International Consultation on Incontinence Questionnaire Short Form); scores 1-21, higher the number - worse outcome
Secondary outcomes
Factors potentially influencing the effectiveness of the rehabilitation program: mean age
Age in years Advanced age is a risk factor for PFD
Other participant and birth related factors which may have influence on pelvic floor: BMI
BMI (kg/m\^2) Higher BMI is a risk factor for PFD
Other participant and birth related factors which may have influence on pelvic floor: number of births
Number of births (after 22 gestational weeks) Higher number of births is a risk factor for PFD
Other participant and birth related factors which may have influence on pelvic floor: mode of delivery
Mode of delivery: natural, vacuum, forceps, c - section Vacuum or forceps assisted delivery is related to higher PFD rates compared to c - section or natural
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vilnius University
Lead sponsor
Vilnius University Hospital Santaros Klinikos
Collaborator
Vilnius Maternity Hospital
Collaborator