Patient-Reported Outcomes in Women With Postpartum Abdominal Wall Insufficiency (PPAWIS) (EMPOWER)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Wall Defect; Postpartum Complication; Diastasis Recti and Weakness of the Linea Alba; Abdominal Wall Anomaly
• Intervention / Treatment: Other: Routine Clinical Care

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Magdalena Halska; Phone Number: 607 870 690; Email: worldofsurge@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Routine Clinical Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 6 months after baseline (window 5-7 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sexual Function (FSFI)	Change from baseline in Female Sexual Function Index (FSFI) total score (and domains, if applicable).	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).	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.	Baseline and 12 months after baseline (window 11-13 months)

Collaborators and Investigators

• Sponsor: Swissmed Hospital
• Collaborators: Medical University of Gdansk; Śmietański Hernia Center
• Investigators: Principal Investigator: Maciej Śmietański, Prof., Śmietański Hernia Center, LUX MED Hospital in Gdańsk; Study Chair: Sylwia Jędrzejewska, MD, PhD, Polish Sexological Society

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; patient-reported outcomes; women's health; sexual function; PROMs; core stability; abdominal wall reconstruction; postpartum abdominal wall insufficiency; PPAWIS
• Additional Relevant MeSH Terms: Diastasis Recti And Weakness Of The Linea Alba
• Other Study ID Numbers: PPAWIS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: IPD will be made available beginning 6 months after publication of the primary results and will remain available for 5 years.
• IPD Sharing Access Criteria: Access will be provided through controlled access. Requests must include a research proposal, analysis plan, and documentation of ethics approval (if applicable). Requests will be reviewed by the study steering group. Approved requestors will be required to sign a data use agreement specifying permitted uses, prohibiting re-identification attempts, and requiring secure data storage. Data will be shared in a de-identified format.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No