Obstetric Anal Sphincter Injury
Conditions
Keywords
obstetric tear, women's health, anal incontinence, obstetric anal sphincter injury
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.
Detailed description
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.
Interventions
OTHERGroup Session
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.
Sponsors
Hanna Jangö
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
2 groups - 1 intervention, 1 control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Obstetric Anal Sphincter Injury (OASI - Grade 3-4 tear) and clinical follow-up postpartum at the "Pelvic Clinic" at Herlev Hospital * 18 years of age or above and the capacity to provide informed consent * Fluent in Danish language
Exclusion criteria
* Referred patients from other hospitals due to complicated healing * Patients where other Hospitals are responsible for the clinical follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICIQ-B Quality of Life Domain | From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum | 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. |
| Symptoms of Anal Incontinence (Cohort) | From 8-14 days and at 1-1.5, 3, 6 and 9-12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICIQ-B (total) score | From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum | 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. 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. |
| Anal Incontinence symptoms | From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months | 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. No score/scale is used. |
| EAUS | At 9-12 months clinical follow-up | Assessment of defects in anal sphincter complex by endoanal ultrasound . Between the Intervention and the Control group, and for all participants (the cohort). No score/scale is used. |
| Wound dehiscence | At early clinical follow-up (8-14 days postpartum) | 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). No score/scale is used. |
| Infection | At early clinical follow-up (8-14 days postpartum) | 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). No score/scale is used. |
| Prolapse | At 9-12 months clinical follow-up | 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). No score/scale is used. |
| Urinary incontinence | At 3, 6 and 9-12 months postpartum | 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. The ICIQ-UI-SF (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) score i derived from 3 of the 4 questions. The score ranges from 0 to 21 points. A higher score indicating a worse outcome. |
| Pelvic symptoms | At baseline, 3, 6 and 9-12 months | 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. No score/scale is used. |
| Number of clinical follow-ups | From delivery to 12 months postpartum | 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). No score/scale is used. |
| EPDS | Baseline (1-1.5 months), 6 months and 9-12 months | 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. EPDS consists of 10 questions with each answer ranking from 0-3 points. Minimum 0 and maximum 30 points, with higher score meaning worse outcome. If total score is 10 or above it is considered as a potential depression requering treatment and follow-up is needed. |
| Body Image | Questionnaire at 6 months and 9-12 months postpartum | Body image score (FGSIS: Femal Genital Self-Image Scale) at 9-12 months for the intervention and the control group , and for all participants in the cohort. FGSIS consists of 7 items, where participants rate statements on a scale from 1 (strongly disagree) to 4 (strongly agree). The results are summed into a total score, with higher numbers indicating a more positive self-perception of the pelvic area. |
| Sexual function | 6 and 9-12 months postpartum | 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. No score/scale is used. |
Countries
Denmark
Contacts
CONTACTHanna Jango, MD, PhD, Associate Professor
CONTACTIben O Hansen, MD
PRINCIPAL_INVESTIGATORHanna Jango, MD, PhD, Associate Professor
Department of Gynecology and Obstetrics at Herlev Hospital
Outcome results
None listed