Urinary IncontinenceRECOVERNCT07430865
The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation
A study testing Early individualized pelvic floor muscle training (PFMT) in people with Urinary Incontinence and Pelvic Organ Prolapse (POP), run by Vastra Gotaland Region at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Pelvic Organ Prolapse (POP), Bowel Symptoms
- What is being tested?
- Early individualized pelvic floor muscle training (PFMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 2 sitesSweden
- Study dates
- 7 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska hospital, Östra
Gothenburg, 43541
Sabine Vesting, PhD, 0722095484, sabine.vesting@gu.se
- Recruiting
University of Gothenburg
Gothenburg
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse (POP), Bowel Symptoms, Postpartum, Physiotherapy and Rehabilitation, Pelvic Floor Muscle Training
- Being tested
- Early individualized pelvic floor muscle training (PFMT)
- Medical subject headings
- Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early individualized pelvic floor muscle training (PFMT)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Assessed 6 weeks and 6 months postpartum
Secondary outcomes (4)
Bladder, vaginal bulge/prolapse, and sexual function.
Pelvic Floor Questionnaire - Pregnancy and Postpartum (PFQ-PP)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Assessed at 6 weeks and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start7 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430865
- Sponsor's protocol ID
- 286551
- Other IDs
- ALFGBG-1015613
- Acronym
- RECOVER
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RECOVER Study - Recovery of Pelvic Floor Structure and Function After Vaginal Childbirth- a Longitudinal Cohort Study With an Embedded Pilot Trial
- ClinicalTrials.gov ID
- NCT07430865
- Acronym / sponsor ID
- RECOVER / 286551
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse (POP), Bowel Symptoms, Postpartum, Physiotherapy and Rehabilitation, Pelvic Floor Muscle Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early individualized pelvic floor muscle training (PFMT) | Experimental | Behavioral: 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Early individualized pelvic floor muscle training (PFMT) |
Primary outcome
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.
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.
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.
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
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
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
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
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.
4 secondary outcomes
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.
Patient's global impression of improvement (PGI-I)
Time frame: 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.
Pelvic floor muscle strength and tone
Time frame: Assessed at 6 weeks and 6 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early individualized pelvic floor muscle training (PFMT) in people with Urinary Incontinence and Pelvic Organ Prolapse (POP), run by Vastra Gotaland Region at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Vesting, PhD (0046722095484, sabine.vesting@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal symptoms (time frame: Participants will complete the ICIQ-VS at 6 weeks, 4, 6 and 12 months postpartum.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.