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

Официальное название

Prevention of Female Pelvic Floor Dysfunction Rehabilitation Postpartum.

Обзор

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).

Подробное описание

Objectives of the Biomedical Research:

* To evaluate gynaecological examination data at 6-8 weeks postpartum, with additional assessment of: experienced pelvic floor dysfunction (PFD) symptoms and their impact on quality of life, pelvic organ positioning (Pelvic Organ Prolapse Quantification system - POP-Q), pelvic floor muscle (PFM) strength, fecal incontinence, diastasis recti abdominis (DRA), and pelvic/perineal ultrasound findings. * To evaluate patient examination data conducted by a physical medicine and rehabilitation physician and a physiotherapist at 6-10 weeks postpartum. * To assess changes in pelvic floor muscle activity, PFD symptoms, pelvic organ position, following the training procedures and at 6 and 12 months post-intervention. * To compare changes among two groups:

Supervised training (specialist-led);

Self-training at home (based on specialist recommendations);

* To compare gynecological examination data, Oxford Scale scores, and St. Mark's scores among the study groups. * To compare changes in women's quality of life, sexual function, and clinical outcomes between the study groups based on validated questionnaires. * To develop recommendations for specialists and the public regarding the prevention of postpartum pelvic floor dysfunction based on the study findings.

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.

Вмешательства

• Поведенческое Rehabilitation postpartum
  * 4 Times biofeedback training * 10 times physiotherapy with specialist * 10 times transcutaneal electrostimulation (TENS)
• Поведенческое Self-training
  * training at home after physiotherapist instructions * using an app to record training frequency, length

Первичные конечные точки

• Improvement in pelvic floor dysfunction symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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)]

Вторичные конечные точки (4)

• Factors potentially influencing the effectiveness of the rehabilitation program: mean age [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Asked and documented at first postpartum visit, 6-8 weeks postpartum]

Критерии участия

Критерии включения

• 18 years or older
• This pregnancy was singleton
• No contraindications for physical activity
• No connective tissue disorders (for example Ehlers-Danlos syndrome)
• No neurological disorders to influence pelvic floor symptoms (for example clinically significant spinal disc herniation)

Критерии исключения

• Younger than 18 years
• Twins or triplet pregnancy
• Contraindications for physical activity
• Connective tissue disorders
• Neurological disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Литва · 1 центр

• Vilnius University: study centers: "Vilnius University Hospital " Santaros Clinic", "Vilni — Vilnius

Публикации

• 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. PMID 32378735
• 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. PMID 36995416
• 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. PMID 39694630
• 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. PMID 33923810

Идентификаторы

NCT: NCT07426770 · 2023/6-1527-986 · Vilnius University · Vilnius University Hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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