The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation (RECOVER)

The RECOVER Study - Recovery of Pelvic Floor Structure and Function After Vaginal Childbirth- a Longitudinal Cohort Study With an Embedded Pilot Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Recovery; Pelvic Floor; Bowel Symptoms; Postpartum; Pelvic Floor Muscle Training; Pelvic Organ Prolapse (POP); Physiotherapy and Rehabilitation
• Intervention / Treatment: Behavioral: Early individualized pelvic floor muscle training (PFMT)

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 Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabine Vesting, PhD; Phone Number: 0046722095484; Email: sabine.vesting@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • University of Gothenburg
  • Gothenburg, Sweden, 43541
    • Recruiting
    • Sahlgrenska hospital, Östra
    • Contact: Sabine Vesting, PhD; Phone Number: 0722095484; Email: sabine.vesting@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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	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	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	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.	Assessed 6 weeks and 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder, vaginal bulge/prolapse, and sexual function.	Pelvic Floor Questionnaire - Pregnancy and Postpartum (PFQ-PP)	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).	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.	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.	Assessed at 6 weeks and 6 months postpartum

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Prolapse; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Pelvic Organ Prolapse
• Other Study ID Numbers: 286551; ALFGBG-1015613 (Other Grant/Funding Number: Research funding provided through the ALF agreement by Västra Götaland Region (VGR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, the plan for sharing individual participant data (IPD) has not been finalized. Decisions about data sharing will consider participant privacy, ethical approvals, and institutional guidelines. De-identified data may potentially be made available to qualified researchers in the future, following approval from the study team and relevant ethics committees.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No