Trials / Recruiting

RecruitingNCT07426770

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

Prevention of Female Pelvic Floor Dysfunction Rehabilitation Postpartum.

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 80 (estimated)

Sponsor: Vilnius University · Academic / Other
Sex: Female
Age: 18 Years – 50 Years
Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

Interventions

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

Timeline

Start date: 2024-01-30
Primary completion: 2027-09-30
Completion: 2029-09-30
First posted: 2026-02-23
Last updated: 2026-02-23

Locations

1 site across 1 country: Lithuania

Source: ClinicalTrials.gov record NCT07426770. Inclusion in this directory is not an endorsement.