Urinary IncontinencePelvic Organ Prolapse (POP)Bowel SymptomsPostpartumPhysiotherapy and RehabilitationPelvic Floor Muscle TrainingPelvic FloorRecovery
Investigational drug(s) / intervention(s)
Early individualized pelvic floor muscle training (PFMT)
Early 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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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