The goal of this observational study with an embedded pilot clinical trial is to learn how the pelvic floor recovers after vaginal childbirth and whether early individualized pelvic floor muscle training can improve recovery in people who experience pelvic floor symptoms after vaginal delivery. The main questions it aims to answer are: * How do pelvic floor muscles and surrounding tissues change and recover during the first year after vaginal childbirth? * How are these structural changes and their recovery related to urinary, bowel, and vaginal symptoms? * In participants with pelvic floor symptoms after vaginal childbirth, does early individualized pelvic floor muscle training improve symptoms and support structural recovery compared with usual care? Researchers will compare participants who receive the early pelvic floor muscle training to those receiving standard postpartum care to see if the training helps improve pelvic floor function and reduce symptoms. Participants will: Attend clinic visits at six weeks, and six months after childbirth Complete questionnaires about urinary, bowel, and vaginal symptoms, as well as physical activity and quality of life at six weeks, and four, six months, and twelve months after childbirth Undergo clinical pelvic floor assessments, including vaginal palpation of muscle strength, tone, and perineal body stability Have ultrasound examinations of the pelvic floor to assess muscle structure, tissue integrity, and perineal body morphology For those in the pilot trial, participate in an early, individualized pelvic floor muscle training program This study will provide important information about how the pelvic floor heals after childbirth, how structural changes are linked to symptoms, and whether early personalized training can help prevent long-term problems.
The RECOVER study is a prospective observational cohort with an embedded pilot randomized controlled trial (RCT) designed to investigate postpartum recovery of the pelvic floor and the effects of early, individualized pelvic floor training. Pelvic floor disorders, such as urinary incontinence, vaginal heaviness, and pelvic organ prolapse, are common after vaginal childbirth and can significantly reduce quality of life and limit physical activity. Vaginal deliveries are the primary risk factor, yet little is known about how anatomical changes in different pelvic floor structures, including the levator ani muscles, perineal body, and urethral support, relate to symptoms and function. The study recruits approximately 380 participants at week 36 of pregnancy and follows them for 12 months postpartum. Data collection occurs at 6 weeks, 4 months, 6 months, and 12 months, including self-reported questionnaires, ultrasound and clinical assessments. The pilot RCT randomizes 124 symptomatic participants to either standard postpartum care or early (2-3 weeks after delivery) individualized physiotherapy. Ultrasound assessments, including transperineal and endovaginal imaging, are used to evaluate the pelvic floor's morphology, such as bladder neck height, urogenital and levator ani hiatus, levator ani tears, and perineal body integrity. Clinical assessments include vaginal palpation of pelvic floor muscle strength, tone and perineal body integrity. Pelvic floor symptoms are measured by validated questionnaires. Primary outcomes are urinary, vaginal, and bowel symptoms, as well as pelvic floor morphology. Secondary outcomes include self-efficacy for physical activity, adherence to training, and perceived improvements. Data are analyzed to identify associations between anatomical changes, symptoms, obstetric factors, and intervention effects. This research aims to provide detailed understanding of postpartum pelvic floor recovery, identify factors influencing recovery, and evaluate the feasibility and preliminary effectiveness of early, individualized pelvic floor interventions. Findings are expected to inform best practices for postpartum care, guide individualized rehabilitation, and help prevent long-term pelvic floor dysfunction, thereby supporting lifelong pelvic health and physical activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
380
Participants receive individualized pelvic floor muscle training (PFMT) delivered by a physiotherapist starting 2-3 weeks postpartum. The program must include pelvic floor exercises at least three times per week, with three sets of 8-10 contractions per session, progressing from light to stronger and endurance-focused contractions. Physiotherapists may also include relaxation techniques, hip, back, and abdominal exercises, breathing exercises, and advice on general physical activity according to each participant's needs. Treatment is adapted based on ultrasound images and a video of pelvic floor contractions, allowing physiotherapists to tailor exercises to any detected tears or weaknesses. All interventions are documented in a checklist to record which components were delivered. Ultrasound files and videos are provided for physiotherapists to guide treatment, but the assessor remains blinded to group allocation.
University of Gothenburg
Gothenburg, Sweden
Vaginal symptoms
International Consultation on Incontinence Questionnaire - Vaginal Symptoms Module (ICIQ-VS). The ICIQ-VS is a brief, validated questionnaire assessing vaginal symptoms, including sensations of prolapse, and their impact on sexual activity and daily life. The instrument is sensitive to changes over time and demonstrates robust validity for assessing the construct of pelvic organ prolapse.
Time frame: Participants will complete the ICIQ-VS at 6 weeks, 4, 6 and 12 months postpartum.
Urinary incontinence
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). The ICIQ-UI has an A grade recommendation according to the International Consultation on Incontinence, having demonstrated adequate validity, reliability, and responsiveness across several patient groups and trials. The ICIQ-UI short form consists of three questions that assess the severity, frequency, and degree of bother associated with urine leakage. Responses are scored on a scale from 0 to 21, with 21 indicating the most severe urine leakage. The fourth question categorizes the type of urine leakage as urgency, stress, nocturia, post-voiding, or mixed urinary incontinence.
Time frame: Participants will complete the ICIQ-UI short form at 6 weeks, 4, 6 and 12 months postpartum.
Bowel function
Pelvic Floor Questionnaire - Pregnancy and Postpartum (PFQ-PP). The PFQ-PP is a validated questionnaire specifically developed to evaluate postpartum pelvic floor symptoms. It covers bladder, bowel, vaginal bulge/prolapse, and sexual function. A Swedish version of the PFQ-PP is available and has demonstrated reliability and validity in postpartum populations.
Time frame: Participants will complete the PFQ-PP at 2 and 6 weeks, 4, 6 and 12 months postpartum.
Changes in levator hiatus area
Changes in levator hiatus area in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Changes in levator plate length
Changes in levator plate length in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Changes in bladder neck height
Changes in bladder neck height in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Changes in urogenital hiatus
Changes in urogenital hiatus in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Time frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Qualitative measures for perineal body integrity
"Hourglass sign" - a visual ultrasound pattern indicating focal narrowing or discontinuity in perineal tissue. "Band of tissue" sign - presence or absence of continuous fibromuscular tissue connecting the levator ani to the perineal body. Anovaginal distance measured via endovaginal ultrasound. Perineal body thickness, scaring and stability assessed by high resolution ultrasound and standardized vaginal palpation.
Time frame: Assessed 6 weeks and 6 months postpartum
Bladder, vaginal bulge/prolapse, and sexual function.
Pelvic Floor Questionnaire - Pregnancy and Postpartum (PFQ-PP)
Time frame: Participants will complete the PFQ-PP at 2 and 6 weeks, 4, 6 and 12 months postpartum.
Patient's global impression of improvement (PGI-I)
Participants will be asked to rate their overall impression of symptom improvement at 4, 6 and 12 months postpartum on a 7-step scale (7= very much worse, to 1= very much better).
Time frame: Participants will complete the PGI-I 4, 6 and 12 months postpartum.
Pregnancy Exercise Self Efficacy Scale (P-ESES)
Participants will rate their perceived Exercise Self-Efficacy on the Pregnancy-Exercise Self-Efficacy Scale.
Time frame: Participants will complete the P-ESES at 6 weeks, 4, 6 and 12 months postpartum.
Pelvic floor muscle strength and tone
Assessed via vaginal palpation. Strength and endurance rated according to the PERFECT scheme (Power (mod oxford 0-5), Endurance, Repetitions, Fast contractions, Every Contraction Timed). Muscle tone evaluated using the Reissing scale (+3 to -3), providing a standardized assessment of resting pelvic floor muscle tone.
Time frame: Assessed at 6 weeks and 6 months postpartum
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