Diastasis Recti and Weakness of the Linea AlbaEMPOWERNCT07407374
Patient-Reported Outcomes in Women With Postpartum Abdominal Wall Insufficiency (PPAWIS)
An observational study of Diastasis Recti and Weakness of the Linea Alba and Abdominal Wall Defect, run by Swissmed Hospital.
Trial summary
Postpartum abdominal wall insufficiency syndrome (PPAWIS) is a multidimensional condition that may affect physical function, quality of life, body image, and sexual health in women after childbirth. Anatomical findings alone do not fully explain symptom burden or patient experience. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Diastasis Recti and Weakness of the Linea Alba, Abdominal Wall Defect, Postpartum Complication
- What is being tested?
- Routine Clinical Care
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 1 Jan 2027
- Phase
- Observational
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 18-65 years with postpartum abdominal wall insufficiency syndrome (PPAWIS), evaluated and managed in routine clinical care at the study site. Participants are assessed using validated patient-reported outcome measures at baseline and during follow-up to characterize symptom burden and changes over time.
Who may be able to join
- Female, age 18-65 years
- Postpartum status: at least 6 months after last delivery
- Clinical diagnosis of postpartum abdominal wall insufficiency syndrome (PPAWIS), defined by abdominal wall dysfunction symptoms and/or significant quality-of-life impact, with supportive findings on physical examination and/or imaging (e.g., diastasis recti and/or related abdominal wall insufficiency features)
- Receiving routine clinical care for PPAWIS at the study site (surgical)
- Able and willing to provide informed consent and complete patient-reported outcome questionnaires at baseline and follow-up
Who cannot join
- Current pregnancy
- Planned pregnancy during the follow-up period (up to 12 months), if expected to interfere with outcome assessment
- Inability to complete questionnaires due to cognitive impairment or insufficient language proficiency in the validated questionnaire language version
- Severe uncontrolled psychiatric condition that, in the investigator's opinion, would prevent informed consent or reliable questionnaire completion
- Participation in another interventional study that could materially affect patient-reported outcomes related to abdominal wall function during the follow-up period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Observational Cohort Study of Quality of Life, Body Image, and Sexual Function in Women With Postpartum Abdominal Wall Insufficiency Syndrome (PPAWIS) Using Patient-Reported Outcome Measures
Postpartum abdominal wall insufficiency syndrome (PPAWIS) is a multidimensional condition that may affect physical function, quality of life, body image, and sexual health in women after childbirth. Anatomical findings alone do not fully explain symptom burden or patient experience.
This prospective observational cohort study will collect validated patient-reported outcome measures (PROMs) from women with PPAWIS receiving routine care. PROMs will be assessed at baseline and during follow-up to describe symptom burden and changes over time. The study aims to improve understanding of the patient-centered impact of PPAWIS and to support development of standardized assessment pathways in clinical practice.
Read the detailed description
his is a prospective observational cohort study conducted in the setting of routine clinical care at Śmietański Hernia Center in Gdańsk (LUX MED Hospital) with collaboration from Medical University of Gdańsk. The study focuses on patient-centered outcomes in women with postpartum abdominal wall insufficiency syndrome (PPAWIS), a condition characterized by variable combinations of abdominal wall dysfunction and psychosocial impact after childbirth.
Participants will complete standardized, validated PROMs capturing quality of life, body image, and sexual function. Assessments will be performed at baseline (at/around qualification for routine care) and at predefined follow-up time points (e.g., 6 and 12 months). Clinical and demographic variables relevant for interpretation (e.g., time since last delivery, BMI, coexisting abdominal wall findings, and type of routine care received) will be recorded in a structured manner.
The study is non-interventional: treatment decisions and clinical management are determined by clinicians and patients according to usual practice and are not assigned by the research protocol. The primary purpose is to quantify baseline burden and describe longitudinal changes in PROMs, and to explore associations between patient-reported outcomes and selected clinical characteristics to inform future standardization of assessment and care pathways.
Data will be collected and stored using pseudonymized study identifiers. Participation is voluntary and can be withdrawn at any time without affecting clinical care.
- Conditions
- Diastasis Recti and Weakness of the Linea Alba, Abdominal Wall Defect, Postpartum Complication, Abdominal Wall Anomaly
- Being tested
- Routine Clinical Care
- Keywords
- PROMs, postpartum abdominal wall insufficiency, PPAWIS, patient-reported outcomes, sexual function, women's health, core stability, quality of life, abdominal wall reconstruction
- Medical subject headings
- Diastasis Recti And Weakness Of The Linea Alba
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Clinical CareOther
No intervention is assigned by the research protocol. Clinical management is determined by clinicians and patients according to usual practice; the study collects patient-reported outcome measures longitudinally.
| Study group | Role | What they receive |
|---|---|---|
| Women with PPAWIS (Routine Care) | Participants are women diagnosed with postpartum abdominal wall insufficiency syndrome (PPAWIS) receiving routine clinical care as determined by the treating clinicians and patient preferences. Management include surgical approaches according to usual practice. No intervention is assigned by the research protocol. Patient-reported outcome measures are collected at baseline and during follow-up. Receives: Other: Routine Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (WHOQOL-BREF)
Change from baseline in the WHOQOL-BREF domain scores and overall quality of life/health items in women with PPAWIS receiving routine care.
Measured: Baseline and 6 months after baseline (window 5-7 months)
Secondary outcomes (3)
Change in Sexual Function (FSFI)
Change from baseline in Female Sexual Function Index (FSFI) total score (and domains, if applicable).
Measured: Baseline and 6 months after baseline (window 5-7 months)
Change in Body Image (Body Image scale)
Change from baseline in validated body image questionnaire score (instrument as specified in the study protocol and local language version).
Measured: Baseline and 6 months after baseline (window 5-7 months)
Sustained Change in Quality of Life (WHOQOL-BREF)
Change from baseline in WHOQOL-BREF at long-term follow-up.
Measured: Baseline and 12 months after baseline (window 11-13 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diastasis Recti and Weakness of the Linea AlbaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swissmed Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk, Śmietański Hernia Center
- Responsible party
- Sponsor
- Investigators
- Maciej Śmietański, Prof., Principal investigator, Śmietański Hernia Center, LUX MED Hospital in GdańskSylwia Jędrzejewska, MD, PhD, Study chair, Polish Sexological Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407374
- Sponsor's protocol ID
- PPAWIS-01
- Acronym
- EMPOWER
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in publications will be shared, including baseline and follow-up patient-reported outcome measure scores and a limited set of key clinical and demographic variables necessary to reproduce analyses (e.g., age range, BMI category, time since last delivery, presence of relevant abdominal wall findings). Direct identifiers will not be shared. Data will be pseudonymized and assessed for re-identification risk prior to release. Data will be shared for research purposes related to postpartum abdominal wall dysfunction and patient-reported outcomes, subject to approval of a qualified research proposal and execution of a data use agreement.
Publications
Smietanski M, Smietanska IA, Zamkowski M. Post-partum abdominal wall insufficiency syndrome (PPAWIS): lessons learned from a single surgeon's experience based on 200 cases. BMC Surg. 2022 Aug 8;22(1):305. doi: 10.1186/s12893-022-01757-y.
PubMed 35941642
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Quality of Life, Body Image, and Sexual Function in Women With Postpartum Abdominal Wall Insufficiency Syndrome (PPAWIS) Using Patient-Reported Outcome Measures
- ClinicalTrials.gov ID
- NCT07407374
- Acronym / sponsor ID
- EMPOWER / PPAWIS-01
- Conditions
- Diastasis Recti and Weakness of the Linea Alba, Abdominal Wall Defect, Postpartum Complication, Abdominal Wall Anomaly
- Keywords
- PROMs, postpartum abdominal wall insufficiency, PPAWIS, patient-reported outcomes, sexual function, women's health, core stability, quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Swissmed HospitalUniversity, hospital or other
- Collaborators
- Medical University of Gdansk, Śmietański Hernia Center
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 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.
Postpartum abdominal wall insufficiency syndrome (PPAWIS) is a multidimensional condition that may affect physical function, quality of life, body image, and sexual health in women after childbirth. Anatomical findings alone do not fully explain symptom burden or patient experience.
This prospective observational cohort study will collect validated patient-reported outcome measures (PROMs) from women with PPAWIS receiving routine care. PROMs will be assessed at baseline and during follow-up to describe symptom burden and changes over time. The study aims to improve understanding of the patient-centered impact of PPAWIS and to support development of standardized assessment pathways in clinical practice.
Detailed description
his is a prospective observational cohort study conducted in the setting of routine clinical care at Śmietański Hernia Center in Gdańsk (LUX MED Hospital) with collaboration from Medical University of Gdańsk. The study focuses on patient-centered outcomes in women with postpartum abdominal wall insufficiency syndrome (PPAWIS), a condition characterized by variable combinations of abdominal wall dysfunction and psychosocial impact after childbirth.
Participants will complete standardized, validated PROMs capturing quality of life, body image, and sexual function. Assessments will be performed at baseline (at/around qualification for routine care) and at predefined follow-up time points (e.g., 6 and 12 months). Clinical and demographic variables relevant for interpretation (e.g., time since last delivery, BMI, coexisting abdominal wall findings, and type of routine care received) will be recorded in a structured manner.
The study is non-interventional: treatment decisions and clinical management are determined by clinicians and patients according to usual practice and are not assigned by the research protocol. The primary purpose is to quantify baseline burden and describe longitudinal changes in PROMs, and to explore associations between patient-reported outcomes and selected clinical characteristics to inform future standardization of assessment and care pathways.
Data will be collected and stored using pseudonymized study identifiers. Participation is voluntary and can be withdrawn at any time without affecting clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with PPAWIS (Routine Care) | – | Other: Routine Clinical CareParticipants are women diagnosed with postpartum abdominal wall insufficiency syndrome (PPAWIS) receiving routine clinical care as determined by the treating clinicians and patient preferences. Management include surgical approaches according to usual practice. No intervention is assigned by the research protocol. Patient-reported outcome measures are collected at baseline and during follow-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18-65 years with postpartum abdominal wall insufficiency syndrome (PPAWIS), evaluated and managed in routine clinical care at the study site. Participants are assessed using validated patient-reported outcome measures at baseline and during follow-up to characterize symptom burden and changes over time.
Key inclusion criteria (5 listed)
- Female, age 18-65 years
- Postpartum status: at least 6 months after last delivery
- Clinical diagnosis of postpartum abdominal wall insufficiency syndrome (PPAWIS), defined by abdominal wall dysfunction symptoms and/or significant quality-of-life impact, with supportive findings on physical examination and/or imaging (e.g., diastasis recti and/or related abdominal wall insufficiency features)
- Receiving routine clinical care for PPAWIS at the study site (surgical)
- Able and willing to provide informed consent and complete patient-reported outcome questionnaires at baseline and follow-up
Key exclusion criteria (5 listed)
- Current pregnancy
- Planned pregnancy during the follow-up period (up to 12 months), if expected to interfere with outcome assessment
- Inability to complete questionnaires due to cognitive impairment or insufficient language proficiency in the validated questionnaire language version
- Severe uncontrolled psychiatric condition that, in the investigator's opinion, would prevent informed consent or reliable questionnaire completion
- Participation in another interventional study that could materially affect patient-reported outcomes related to abdominal wall function during the follow-up period
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 |
|---|---|---|
| Routine Clinical CareNo intervention is assigned by the research protocol. Clinical management is determined by clinicians and patients according to usual practice; the study collects patient-reported outcome measures longitudinally. | Other | Women with PPAWIS (Routine Care) |
Primary outcome
Change in Quality of Life (WHOQOL-BREF)
Time frame: Baseline and 6 months after baseline (window 5-7 months)
Change from baseline in the WHOQOL-BREF domain scores and overall quality of life/health items in women with PPAWIS receiving routine care.
3 secondary outcomes
Change in Sexual Function (FSFI)
Time frame: Baseline and 6 months after baseline (window 5-7 months)
Change in Body Image (Body Image scale)
Time frame: Baseline and 6 months after baseline (window 5-7 months)
Sustained Change in Quality of Life (WHOQOL-BREF)
Time frame: Baseline and 12 months after baseline (window 11-13 months)
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 12 Feb 2026.
- Background: PubMed 35941642Smietanski M, Smietanska IA, Zamkowski M. Post-partum abdominal wall insufficiency syndrome (PPAWIS): lessons learned from a single surgeon's experience based on 200 cases. BMC Surg. 2022 Aug 8;22(1):305. doi: 10.1186/s12893-022-01757-y.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in publications will be shared, including baseline and follow-up patient-reported outcome measure scores and a limited set of key clinical and demographic variables necessary to reproduce analyses (e.g., age range, BMI category, time since last delivery, presence of relevant abdominal wall findings). Direct identifiers will not be shared. Data will be pseudonymized and assessed for re-identification risk prior to release. Data will be shared for research purposes related to postpartum abdominal wall dysfunction and patient-reported outcomes, subject to approval of a qualified research proposal and execution of a data use agreement.
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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.
Maciej Śmietański, Prof. principal investigator
Śmietański Hernia Center, LUX MED Hospital in Gdańsk
Sylwia Jędrzejewska, MD, PhD study chair
Polish Sexological Society
Questions about this trial
What is this clinical trial studying?
An observational study of Diastasis Recti and Weakness of the Linea Alba and Abdominal Wall Defect, run by Swissmed Hospital.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Magdalena Halska (607 870 690, worldofsurge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (WHOQOL-BREF) (time frame: Baseline and 6 months after baseline (window 5-7 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07407374, which also lists 1 linked publication.
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 12 Feb 2026.