The RECOVER Study - Recovery of Pelvic Floor Structure and Function After Vaginal Childbirth- a Longitudinal Cohort Study With an Embedded Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 380
- Locations
- 2
- Primary Endpoint
- Changes in bladder neck height
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
In the pilot randomized controlled trial, researchers analyzing ultrasound images and clinical data are masked to participants' group assignments and symptom reports. This ensures that the assessment of pelvic floor structure and function is unbiased. Participants and treating physiotherapists are not masked because the intervention involves individualized training that cannot be concealed.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Individuals (over 18 years) who delivered a single child vaginally between 37 and 41 weeks of gestation, with a birthweight of at least 2500 grams.
Exclusion Criteria
- •Delivered via c-section
- •Multiparous with previous third- or fourth-degree tears
- •History of major urogynecological surgery
- •Known neurological disorder (e.g., stroke, multiple sclerosis) that could affect the assessment outcomes
- •Severe connective tissue disorders that could affect the assessment outcomes
- •New pregnancy of more than 6 weeks during the study period
- •Pain with vaginal penetration, tampon use, or gynecological examinations that would prevent participation in assessments
- •Visible signs for wound complications assessed via REEDA tool (redness, oedema, ecchymosis, discharge, approximation) will exclude the participants from the first ultrasound assessment and vaginal palpation.
Arms & Interventions
Early individualized pelvic floor muscle training (PFMT)
Individualized early postpartum pelvic floor muscle training starting 2-3 weeks postpartum, based on progressive overload principles. Training is progressively adapted according to tissue healing, pain, symptoms, and ultrasound findings. The target is 8-10 maximal voluntary contractions held for 6-8 seconds, performed in 3 sets, 2-3 times daily for at least 12 weeks, with progression in intensity, endurance, and motor control while prioritizing contraction quality over quantity. Load (intensity, volume, and complexity) is adjusted in response to recovery and symptom response.
Participants receive structured education, an exercise diary, and regular digital follow-ups (every second week for 3 months, then every fourth week), with additional physical visits if needed for guiding of pelvic floor muscle contraction
Intervention: Early individualized pelvic floor muscle training (PFMT) (Behavioral)
Standard postpartum care
Participants in this group receive routine postpartum care in Sweden, which typically includes 1-2 visits at the midwife center. The midwife may recommend that participants seek physiotherapy if needed. Any physiotherapy visits that occur are self-reported by participants and documented at the end of the study to evaluate the type, frequency, and content of care received. Participants do not have access to ultrasound files before the end of the study.
Outcomes
Primary Outcomes
Changes in bladder neck height
Time Frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Changes in bladder neck height in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Changes in urogenital hiatus
Time Frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Changes in urogenital hiatus in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Vaginal symptoms
Time Frame: Participants will complete the ICIQ-VS at 6 weeks, 4, 6 and 12 months postpartum.
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.
Urinary incontinence
Time Frame: Participants will complete the ICIQ-UI short form at 6 weeks, 4, 6 and 12 months postpartum.
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.
Bowel function
Time Frame: Participants will complete the PFQ-PP at 2 and 6 weeks, 4, 6 and 12 months postpartum.
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.
Changes in levator hiatus area
Time Frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Changes in levator hiatus area in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Changes in levator plate length
Time Frame: Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
Changes in levator plate length in supine and standing will be assessed by transperineal ultrasound with a curvilinear probe
Qualitative measures for perineal body integrity
Time Frame: Assessed 6 weeks and 6 months postpartum
"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.
Secondary Outcomes
- Bladder, vaginal bulge/prolapse, and sexual function.(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 complete the PGI-I 4, 6 and 12 months postpartum.)
- Pregnancy Exercise Self Efficacy Scale (P-ESES)(Participants will complete the P-ESES at 6 weeks, 4, 6 and 12 months postpartum.)
- Pelvic floor muscle strength and tone(Assessed at 6 weeks and 6 months postpartum)