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

May 21, 2026 updated by: Vastra Gotaland Region

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
380

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • University of Gothenburg
      • Gothenburg, Sweden, 43541
        • Recruiting
        • Sahlgrenska hospital, Östra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Participants will complete the ICIQ-VS at 6 weeks, 4, 6 and 12 months postpartum.
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.
Participants will complete the ICIQ-UI short form at 6 weeks, 4, 6 and 12 months postpartum.
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.
Participants will complete the PFQ-PP at 2 and 6 weeks, 4, 6 and 12 months postpartum.
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
Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
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
Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
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
Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
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
Participants will attend to ultrasound assessments at 6 weeks and 6 months postpartum
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.
Assessed 6 weeks and 6 months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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).
Participants will complete the PGI-I 4, 6 and 12 months postpartum.
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.
Participants will complete the P-ESES at 6 weeks, 4, 6 and 12 months postpartum.
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.
Assessed at 6 weeks and 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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