An interventional study of Rehabilitation postpartum and Self-training in Pelvic Floor Dysfunction, Postpartum Care and Postpartum Comfort, sponsored by Vilnius University. Recruiting at 1 site in Lithuania. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Vilnius University · Not applicable, Interventional, and Prevention
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:
Study participants will:
Objectives of the Biomedical Research:
Supervised training (specialist-led);
Self-training at home (based on specialist recommendations);
Comprehensive Description of Evaluated Outcomes Primary and Secondary Study Endpoints
Primary Endpoints: Changes indicating the effect of applied rehabilitation measures on the reduction and prevention of pelvic dysfunction symptoms:
Change in PFM contraction force and strength according to the Modified Oxford Scale.
Change in POP-Q scores.
St. Mark's Score for fecal incontinence: evaluating the change in score over the course of the study.
Pelvic and perineal ultrasound data: assessing symmetrical PFM contraction, changes in vaginal hiatus width, and urethral mobility. Comparison of results between study groups.
Persistence of PFD symptoms as reported by patients.
Changes in Quality of Life (QoL) and clinical outcome questionnaires: * ICIQ-UI SF (International Consultation on Incontinence Questionnaire Short Form); 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).
Changes in musculoskeletal functions: * Objective assessment of PFM state via contraction force and Pressure Biofeedback activity evaluation.
Assessment of diastasis recti abdominis using palpation and ultrasound.
Pain assessment (abdominal, perineal, pelvic, pubic symphysis, and lumbosacral) using the Visual Analogue Scale (VAS).
Evaluation of gait, balance, and coordination.
Core stability and transversus abdominis activity (using a stabilizer); static endurance tests for abdominal and back muscles.
Secondary Endpoints: Factors potentially influencing the effectiveness of the rehabilitation program:
Demographics and History: Mean age, BMI, parity (number of pregnancies/deliveries), neonatal weight, and head circumference.
Obstetric Factors: Mode of delivery, delivery-related factors (induction, gestational age, fetal presentation, delivery method: natural, ventouse, c-section).
Pathologies: Pregnancy-related diseases (nausea/vomiting, intrahepatic cholestasis, preeclampsia, gestational diabetes), infectious/inflammatory diseases during pregnancy.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →Vilnius University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Woman 6-10 weeks postpartum starts training program with physiotherapist and physical medicine and rehabilitation physician supervision.
Behavioral: Rehabilitation postpartum
Woman 6-10 weeks postpartum starts self- training program at home. At the beginning they are instructed by physiotherapist and physical medicine and rehabilitation physician. This group use an app "squeezy" to remind the to do training and record training time.
Behavioral: Self-training
* 4 Times biofeedback training * 10 times physiotherapy with specialist * 10 times transcutaneal electrostimulation (TENS)
Also known as: Physiotherapy, Biofeedback training, electrostimulation
* training at home after physiotherapist instructions * using an app to record training frequency, length
Also known as: pelvic floor dysfunction app
Improvement in pelvic floor dysfunction symptoms
Self-reported improvement of symptoms (for example: pain, urinary incontinence, fecal incontinence, vaginal "laxity")
Time frame: Asked at the beginning (first postpartum visit, 6-8 weeks postpartum), after first set of training (6months), after second set of training (12 months)
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.
Time frame: Measured before training, immediately after first set of training, 6 months from the beginning, before starting second set of training and immediately after second set of training, about 12 months from the beginning
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)
Time frame: Measured before starting the program, after first set of training (6 months from beginning) and after second set of training (12 months from beginning)
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
Time frame: Questionnaires will be given at the beginning (excluding sexual function related questionnaires, due to short time after delivery), after first set of training (6 months from the beginning), after second set of training (12 months from the beginning).
Better voluntary pelvic floor muscle control
observation (compensatory muscles: abdominal, thighs, glutes movements during the contraction)
Time frame: Measured before training, immediately after first set of training, 6 months from the beginning, before starting second set of training and immediately after second set of training, about 12 months from the beginning
Objectively measured change in pelvic floor muscle strength
Contraction measured with Myomed biofeedback device (manometry kPha)
Time frame: Measured before training, immediately after first set of training, 6 months from the beginning, before starting second set of training and immediately after second set of training, about 12 months from the beginning
Quality of Life (QoL) and clinical outcome questionnaires: P-QoL
P-QoL (Prolapse Quality-of-Life Questionnaire) measures the impact of pelvic organ prolapse (POP) on a patient's life across eight domains, with total scores ranging from 0 (best) to 100 (worst). High scores indicate poor quality of life, while lower scores (often \<40 or \<20) indicate higher QOL and improvement after intervention
Time frame: Questionnaires will be given at the beginning (excluding sexual function related questionnaires, due to short time after delivery), after first set of training (6 months from the beginning), after second set of training (12 months from the beginning).
Quality of Life (QoL) and clinical outcome questionnaires: PISQ-IR
PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised) evaluates female sexual function (FSF) in women with pelvic floor disorders (PFD), using a 2.68 summary score cutoff for sexually active (SA) women to identify sexual dysfunction (values \>2.68 indicate no dysfunction). The survey separates patients into SA and not sexually active (NSA) groups. SA Scale: Higher scores indicate better sexual function. A mean score \\(\>2.68\\) suggests no dysfunction, with \\(90\\%\\) sensitivity and \\(73\\%\\) specificity.NSA Scale: Higher scores indicate a greater negative impact of pelvic floor disorders on sexual inactivity.
Time frame: Questionnaires will be given at the beginning (excluding sexual function related questionnaires, due to short time after delivery), after first set of training (6 months from the beginning), after second set of training (12 months from the beginning)
Quality of Life (QoL) and clinical outcome questionnaires: FSFI (Female Sexual Function Index)
FSFI (Female Sexual Function Index) is a 19-item validated questionnaire assessing female sexual function over the past month, with total scores ranging from 2.0 to 36.0. A total score of ≤26.55 is the standard cutoff indicating a potential risk for Female Sexual Dysfunction (FSD). Higher scores indicate better, more robust sexual functioning
Time frame: Questionnaires will be given at the beginning (excluding sexual function related questionnaires, due to short time after delivery), after first set of training (6 months from the beginning), after second set of training (12 months from the beginning)
Quality of Life (QoL) and clinical outcome questionnaires: MOS-SF36
MOS-SF36 (Medical Outcomes Study Short Form-36). s a 36-item, patient-reported survey measuring health-related quality of life across eight dimensions. Scores range from 0 to 100 for each subscale, with higher scores indicating better health functioning or fewer limitations. The survey evaluates physical, mental, and social health domains
Time frame: Questionnaires will be given at the beginning (excluding sexual function related questionnaires, due to short time after delivery), after first set of training (6 months from the beginning), after second set of training (12 months from the beginning)
Factors potentially influencing the effectiveness of the rehabilitation program: mean age
Age in years Advanced age is a risk factor for PFD
Time frame: Asked and documented at first postpartum visit, 6-8 weeks postpartum
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
Time frame: Asked and documented at first postpartum visit, 6-8 weeks postpartum
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
Time frame: Asked and documented at first postpartum visit, 6-8 weeks postpartum
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
Time frame: Asked and documented at first postpartum visit, 6-8 weeks postpartum
Plan to share: Yes — Researchers may share de-identified individual participant data such like: age, bmi, pop-q scores etc. In excell or other analyzable data set.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: It is planned around september 2027-2028
Access criteria: If other researches would like use data from this study they may ask for an IPD. Study protocol and results report will be shared with other researches as a future publication and in clinicaltrials.gov site.
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