Bowel Symptoms, Pelvic Floor, Pelvic Floor Muscle Training, Pelvic Organ Prolapse (POP), Physiotherapy and Rehabilitation, Postpartum, Recovery, Urinary Incontinence
Conditions
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.
Interventions
BEHAVIORALEarly individualized pelvic floor muscle training (PFMT)
Participants receive individualized pelvic floor muscle training (PFMT) delivered by a physiotherapist from 2-3 weeks postpartum. The program is individually progressed according to recovery and aims to gradually achieve the recommended training dose of 8-10 maximal contractions held for 6-8 seconds, performed in three sets, 2-3 times daily, for at least 12 weeks. Participants receive an information booklet covering pelvic floor recovery, pain management, bowel and bladder function, relaxation, physical activity, scar healing, ergonomics, sleep, and sexual health. An exercise diary is used to monitor adherence. Follow-ups are conducted every second week during the first 3 months and thereafter every fourth week. Participants requiring additional guidance in performing pelvic floor contractions are offered in-person physiotherapy visits. All interventions are documented in a checklist to record delivered components. Ultrasound files and videos are provided to guide treatment.
Sponsors
Vastra Gotaland Region
Study design
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
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal symptoms | 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 | 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 | 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 | 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 | 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 |
| Changes in bladder neck height | 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 | 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 |
| Qualitative measures for perineal body integrity | 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
| Measure | Time frame | Description |
|---|---|---|
| Bladder, vaginal bulge/prolapse, and sexual function. | 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) |
| Patient's global impression of improvement (PGI-I) | Participants will complete the PGI-I 4, 6 and 12 months postpartum. | 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). |
| Pregnancy Exercise Self Efficacy Scale (P-ESES) | Participants will complete the P-ESES at 6 weeks, 4, 6 and 12 months postpartum. | Participants will rate their perceived Exercise Self-Efficacy on the Pregnancy-Exercise Self-Efficacy Scale. |
| Pelvic floor muscle strength and tone | Assessed at 6 weeks and 6 months postpartum | 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. |
Countries
Sweden
Contacts
CONTACTSabine Vesting, PhD
Outcome results
None listed