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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.
Women who experience a birth tear involving the anal sphincter (OASI) currently lack a systematic and consistent follow-up programme. There is limited knowledge about how their symptoms develop during the first year after childbirth, and problems such as anal incontinence are likely underreported due to stigma. Studies show women are asking for better support, information, and guidance.
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.
The study is a randomised controlled trial with a 1:1 allocation to either a group-based follow-up programme or standard care. All participants complete questionnaires at 1-1.5 months, 3, 6, and 9-12 months after childbirth, and are offered a clinical examination at 9-12 months postpartum. This includes a gynaecological assessment and 3D endoanal and endovaginal ultrasound.
In addition, the intervention group takes part in three group sessions focusing on healing, physiotherapist-guided pelvic floor muscle exercises, incontinence, emotions, sexual life, and everyday challenges.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 8-14 days and at 1-1.5, 3, 6 and 9-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ICIQ-B (total) score | The change in total ICIQ-Bowel score (all domains). Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time. | From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum |
| Anal Incontinence symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Levator Ani Avulsion | Assessment of levator Ani Avulsion from Endovaginal Ultrasound. Presence, severity and association with symptoms and Quality of Life. Between the Intervention and the Control group at all timepoints, and for all participants (the cohort). | At 9-12 months clinical follow-up |
| Qualitative Component (Intervention group only) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Jango, MD, PhD, Associate Professor | Contact | +4538681612 | hanna.margareta.jangoe@regionh.dk | |
| Iben O Hansen, MD | Contact | +4538689904 | iben.onsberg.hansen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Hanna Jango, MD, PhD, Associate Professor | Department of Gynecology and Obstetrics at Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics at Herlev Hospital | Herlev | Capital Region | 2730 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2026 | Jun 18, 2026 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D004688 | Encopresis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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2 groups - 1 intervention, 1 control
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|
Anal Incontinence symptoms derived from early + late clinical follow-up and relevant ICIQ-B items. Between the Intervention and the Control group at all timepoints. |
| From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months |
| EAUS | Assessment of defects in anal sphincter complex by endoanal ultrasound . Between the Intervention and the Control group, and for all participants (the cohort). | At 9-12 months clinical follow-up |
| Wound dehiscence | Wound dehiscence at early clinical follow-up (8-14 days). Wound dehiscence is divided into with/without involvement of pelvic muscles (With/without involvement of sphincter-complex or total dehiscence). Between the Intervention and the Control group, and for all participants (the cohort) | At early clinical follow-up (8-14 days postpartum) |
| Infection | Wound infection at early clinical follow-up are described by Redness, Edema, Echymosis, dicharge (pus), absces. Women with absces/pus or treated with antibiotics due to infection signs are considered to have a wound infection. Between the Intervention and the Control group, and for all participants (the cohort). | At early clinical follow-up (8-14 days postpartum) |
| Prolapse | Prolapse at 9-12 months clinical follow-up using modified POP-Q. Between the Intervention and the Control group, and for all participants (the cohort). | At 9-12 months clinical follow-up |
| Urinary incontinence | Symptoms of urinary incontinence from questionnaires (ICIQ-UI-SF) at 3, 6 and 9-12 months. Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time. | At 3, 6 and 9-12 months postpartum |
| Pelvic symptoms | Symptoms of prolaps, heavyness, pain from questionnaires (PFDI-20, KAPTAIN). Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time. | At baseline, 3, 6 and 9-12 months |
| Number of clinical follow-ups | Number of clinical follow-ups due to e.g. wound complications or symptoms during the first year postpartum. Between the Intervention and the Control group, and for all participants (the cohort) | From delivery to 12 months postpartum |
| EPDS | Score of Edinburgh postpartum Depression Scale (EPDS) at baseline and 9-12 months. Between the Intervention and the Control group, and for all participants (the cohort) the development over time. | Baseline (1-1.5 months) and 9-12 months |
| Body Image | Body image score (FGSIS) at 9-12 months for the intervention and the control group , and for all participants in the cohort | Questionnaire at 9-12 months postpartum |
| Sexual function | Sexual function at 6 and 9-12 months questionnaire (ICIQ-VS + KAPTAIN). Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time. | 6 and 9-12 months postpartum |
Semi-structured individual or focus-group interviews will explore participants' experiences with the intervention and explore women's experiences of sustaining a perineal tear and any associated symptoms |
| Aprox. 2-8 weeks after concluded intervention |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |