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

NCT07430865 | Recruiting

• 2 other identifiers: 286551ALFGBG-1015613
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 2

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.

Conditions

Bowel Symptoms; Pelvic Organ Prolapse (POP); Physiotherapy and Rehabilitation; Pelvic Floor Muscle Training; Pelvic Floor; Recovery; Urinary Incontinence; Postpartum

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Bladder, vaginal bulge/prolapse, and sexual function.

  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 complete the PGI-I 4, 6 and 12 months postpartum.

• Pregnancy Exercise Self Efficacy Scale (P-ESES)

  Participants will complete the P-ESES at 6 weeks, 4, 6 and 12 months postpartum.

• Pelvic floor muscle strength and tone

  Assessed at 6 weeks and 6 months postpartum

Study Arms (2)

Early individualized pelvic floor muscle training (PFMT)

EXPERIMENTAL

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)

Standard postpartum care

NO INTERVENTION

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.

Interventions

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.

Early individualized pelvic floor muscle training (PFMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (2)

Sahlgrenska hospital, Östra

Gothenburg, 43541, Sweden

RECRUITING

University of Gothenburg

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Central Study Contacts

Sabine Vesting, PhD

CONTACT

0046722095484; sabine.vesting@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-04

Locations

SE (2)