Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention

NCT07667660 | Not Yet Recruiting

• 1 other identifier: H-26012116
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the ADAPT study is to investigate whether a structured, group-based follow-up programme can improve quality of life related to anal incontinence in women with OASI during the first year after childbirth. The study will also describe how symptoms change over time and assess effects on mental health, sexual function, symptoms of prolapse and urinary incontinence, and body image.

Conditions

Obstetric Anal Sphincter Injury

Keywords

obstetric tear; women's health; anal incontinence; obstetric anal sphincter injury

Outcome Measures

Primary Outcomes (2)

• ICIQ-B Quality of Life Domain

  The change in score of the "Quality of Life" Domain in ICIQ-Bowel (Questions 19-23) between the Intervention and the Control Group. ICIQ-B: "International Consultation on Incontinence Questionnaire-Bowel" The ICIQ-B score contains 21 items, 17 of the 21 items are scored items, while the remaining four are unscored 9. Each item is scored on an ordinal scale and contains a 'bother' score rated on a numeric rank scale (NRS). The bother scores are not part of the calculated subscale scores. The 17 scored items are divided into three subscales: Bowel pattern (0-21), bowel control (0-28) and Quality of life (0-26), with a higher score indicating more symptoms.

  From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum

• Symptoms of Anal Incontinence (Cohort)

  Development/fluctuation of anal incontinence and related symptoms for all participants regardless of randomization (cohort) at all timepoints. From questionnaires and clinical follow-up. No score/scale is used.

  From 8-14 days and at 1-1.5, 3, 6 and 9-12 months

Secondary Outcomes (12)

• ICIQ-B (total) score

  From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum

• Anal Incontinence symptoms

  From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months

• EAUS

  At 9-12 months clinical follow-up

• Wound dehiscence

  At early clinical follow-up (8-14 days postpartum)

• Infection

  At early clinical follow-up (8-14 days postpartum)

Other Outcomes (2)

• Levator Ani Avulsion

  At 9-12 months clinical follow-up

• Qualitative Component (Intervention group only)

  Aprox. 2-8 weeks after concluded intervention

Study Arms (2)

Control

NO INTERVENTION

Participants are randomized 1:1 Intervention vs. control. Participants in the Control Group receive the same clinical follow-ups at 8-14 days and 9-12 months after OASI, and the same questionnaires at 1-1.5, 3, 6 and 9-12 months postpartum as the intervention group.

Intervention

ACTIVE COMPARATOR

Participants are randomized 1:1 Intervention vs. control. Participants in the Intervention Group are invited to three group sessions 2-6 months postpartum hosted by doctors and physiotherapists. The group session focus on relevant information, physiotherapist-guided kegel-exercises (pelvic floor mucles exercises) and social interaction between participants. In addition the Intervention group receive the same clinical follow-ups at 8-14 days and 9-12 months after OASI, and the same questionnaires at 1-1.5, 3, 6 and 9-12 months postpartum as the control group.

Other: Group Session

Interventions

Group Session OTHER

Participants in the Intervention Group are invited to three closed group sessions 2-6 months postpartum hosted by doctors and physiotherapists. The group session focus on relevant information (e.g. healing, incontinence, emotions, concerns, sexlife, everyday challenges), kegel-exercises (pelvic floor exercises) and social interaction between participants.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obstetric Anal Sphincter Injury (OASI - Grade 3-4 tear) and clinical follow-up postpartum at the "Pelvic Clinic" at Herlev Hospital
• years of age or above and the capacity to provide informed consent
• Fluent in Danish language

You may not qualify if:

• Referred patients from other hospitals due to complicated healing
• Patients where other Hospitals are responsible for the clinical follow-up

Sponsors & Collaborators

• Hanna Jangö: lead

Study Sites (1)

Department of Gynecology and Obstetrics at Herlev Hospital

Herlev, Capital Region, 2730, Denmark

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Hanna Jango, MD, PhD, Associate Professor

  Department of Gynecology and Obstetrics at Herlev Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Jango, MD, PhD, Associate Professor

CONTACT

+4538681612; hanna.margareta.jangoe@regionh.dk

Iben O Hansen, MD

CONTACT

+4538689904; iben.onsberg.hansen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 2 groups - 1 intervention, 1 control

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)