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NCT Number: NCT07430865

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

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.

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Key information

Conditions

Urinary Incontinence Bowel Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Pelvic Floor Muscle Training Pelvic Organ Prolapse Pelvic Organ Prolapse (POP) Physiotherapy and Rehabilitation Postpartum Prolapse Recovery Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska hospital, Östra, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early individualized pelvic floor muscle training (PFMT)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  1. Bladder, vaginal bulge/prolapse, and sexual 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)

  2. Patient's global impression of improvement (PGI-I)

    Time frame: 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).

  3. Pregnancy Exercise Self Efficacy Scale (P-ESES)

    Time frame: 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.

  4. Pelvic floor muscle strength and tone

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Vesting, PhD

CONTACT

[email protected]

0046722095484

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Acronym: RECOVER

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 24, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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