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| ID | Type | Description | Link |
|---|---|---|---|
| Vilnius University | Other Identifier | Vilnius University is responsible for this study (Bioethics, study enrolment) | |
| Vilnius University Hospital | Other Identifier | This study is going in Vilnius University Hospital "Santaros Clinic" and "Vilniaus gimdymo namai" |
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| Name | Class |
|---|---|
| Vilnius University Hospital Santaros Klinikos | OTHER |
| Vilnius Maternity Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of participants getting specialist supervised training postpartum | Active Comparator | Woman 6-10 weeks postpartum starts training program with physiotherapist and physical medicine and rehabilitation physician supervision. |
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| Group of participants doing self-training with an app | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation postpartum | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pelvic floor dysfunction symptoms | Self-reported improvement of symptoms (for example: pain, urinary incontinence, fecal incontinence, vaginal "laxity") | 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. | 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) | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Factors potentially influencing the effectiveness of the rehabilitation program: mean age | Age in years Advanced age is a risk factor for PFD | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female who had given birth
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karolina Eva Romeikiene, Medical doctor, PHD student | Contact | +37060406142 | eva.romeikiene@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lina Būtėnaitė, MD, PhD | Vilnius University | Study Chair |
| Daiva Bartkevičienė, Assoc. prof. | Vilnius University | Study Director |
| Eglė Pilkionytė, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University: study centers: "Vilnius University Hospital " Santaros Clinic", "Vilniaus Gimdymo Namai" | Recruiting | Vilnius | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32378735 | Background | Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4. | |
| 36995416 | Background |
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Researchers may share de-identified individual participant data such like: age, bmi, pop-q scores etc. In excell or other analyzable data set.
It is planned around september 2027-2028
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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Study participant will do two different options of training postpartum. Group one - training with specialist supervision Group two - self-training
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| Self-training | Behavioral |
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| 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) | 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 | 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. | 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 | 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 | 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) |
BMI (kg/m^2) Higher BMI is a risk factor for PFD |
| 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 | 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 | Asked and documented at first postpartum visit, 6-8 weeks postpartum |
| Vilnius University |
| Principal Investigator |
| Ivona Ivanovska, MD | Vilnius University | Principal Investigator |
| Rūta Petravičienė | Vilnius University | Principal Investigator |
| Karolina Eva Romeikienė, MD, PhD student | Vilnius University | Principal Investigator |
| Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Postpartum pelvic organ prolapse and pelvic floor muscle training: secondary analysis of a randomized controlled trial of primiparous women. Int Urogynecol J. 2023 Jun;34(6):1319-1326. doi: 10.1007/s00192-023-05502-8. Epub 2023 Mar 30. |
| 39694630 | Background | Beamish NF, Davenport MH, Ali MU, Gervais MJ, Sjwed TN, Bains G, Sivak A, Deering RE, Ruchat SM. Impact of postpartum exercise on pelvic floor disorders and diastasis recti abdominis: a systematic review and meta-analysis. Br J Sports Med. 2025 Mar 31;59(8):562-575. doi: 10.1136/bjsports-2024-108619. |
| 33923810 | Background | Romeikiene KE, Bartkeviciene D. Pelvic-Floor Dysfunction Prevention in Prepartum and Postpartum Periods. Medicina (Kaunas). 2021 Apr 16;57(4):387. doi: 10.3390/medicina57040387. |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D004599 | Electric Stimulation Therapy |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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