An interventional study of PFMT and Standard care in Pelvic Floor, Urinary Incontinence and Anal Incontinence, sponsored by University of Southern Denmark. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Prevention
The project seeks to investigate effectiveness of PFMT during pregnancy.
First-time pregnant women will be recruited through visitations received from family doctors in all obstetrics departments of the Southern Denmark Region. Women will be randomised into two groups: ( Pelvic Floor Muscle Training) PFMT and a control group (standard care). The motivation-informed intervention will tackle both exercise engagement and exercise adherence. The women will receive an easily accessible, home-based PFMT program electronically in which they will be motivated to start and engage during pregnancy with continuity after birth. The data regarding pelvic floor disorders will be obtained at baseline, follow-ups once every trimester of pregnancy, as well as six weeks, three months, and six months postpartum with further follow-up after the study. The data regarding obstetric outcomes will be collected from electronic patient records. For evaluation of implementation process, data regarding motivation and training acceptability will be obtained via questionnaire at the baseline and at follow-up together with telephonically interviews during pregnancy and postpartum.
Exclusion Criteria:
A Danish professional pelvic floor physiotherapist together with a midwife and an urogynecologist have created a free of charge training program, which is easily accessible via a danish website "www.kvindekrop.dk" or via the app "Pelvic FloorTrainer". The women will receive an easily accessible, home-based PFMT program electronically in which they will be motivated to start and engage during pregnancy with continuity after birth.
Behavioral: PFMT
The control group will receive routine care - recommendation to do the training without any further instructions.
Behavioral: Standard care
The motivation-informed intervention will tackle both exercise engagement and exercise adherence. Participating women will be introduced to the app and its videos following training. The participants will be introduced not only to muscle training, but also to muscle relaxation. The training will be recommended three to four times a week during pregnancy with further continuity after giving birth.
Standard care
Urinary incontinence (UI) incidence at 3 months postpartum
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score between 0 (perfect continence) and 21 (total incontinence).
Time frame: At 3 months follow-up after giving birth
Urinary incontinence at the 1st trimester of pregnancy
ICIQ-UI SF score between 0-21
Time frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)
Urinary incontinence at the 2nd trimester of pregnancy
ICIQ-UI SF score between 0-21
Time frame: At the follow-up at Gestational age 26 weeks and 0 days
Urinary incontinence incidence at the 3rd trimester of pregnancy
ICIQ-UI SF score between 0-21
Time frame: At the follow-up at Gestational Age 36 weeks and 0 days
Urinary incontinence incidence at 6 weeks postpartum
ICIQ-UI SF score between 0-21
Time frame: At the follow-up at 6 weeks postpartum
Anal incontinence (AI) incidence at inclusion, during the 1st trimester of pregnancy
Colorectal-anal distress inventory 8 (CRAD-8), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100). Answer yes to one of the three questions about anal incontinence will be considered as AI.
Time frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)
Anal incontinence (AI) in the 2nd trimester of pregnancy
Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.
Time frame: At the follow-up at Gestational Age 26 weeks and 0 days
Anal incontinence (AI) incidence in the 3rd trimester of pregnancy
Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.
Time frame: At the follow-up at Gestational Age 36 weeks and 0 days
Anal incontinence (AI) incidence at 6 weeks postpartum
Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.
Time frame: At the follow-up at 6 weeks postpartum
Anal incontinence (AI) incidence at 3 months postpartum
Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.
Time frame: At the follow-up at 3 months postpartum
Anal incontinence (AI) incidence at 6 months postpartum
Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.
Time frame: At the follow-up at 6 months postpartum
Sexual dysfunction incidence at inclusion, during the 1st trimester of pregnancy
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Time frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)
Sexual dysfunction incidence at inclusion, during the 2nd trimester of pregnancy
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Time frame: At the follow-up at Gestational Age 26weeks and 0 days
Sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancy
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Time frame: At the follow-up at Gestational Age 36 weeks and 0 days
Sexual dysfunction incidence at 6 weeks postpartum
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Time frame: At the follow-up at 6 weeks postpartum
Sexual dysfunction incidence at 3 month postpartum
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Time frame: At the follow-up at 3 month postpartum
Sexual dysfunction incidence at 6month postpartum
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Time frame: At the follow-up at 6 month postpartum
Pelvic organ prolapse (POP) incidence at inclusion, during the 1st trimester of pregnancy
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).
Time frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks and 6 days)
Pelvic organ prolapse (POP) incidence, in the 2nd trimester of pregnancy
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).
Time frame: At the follow-up at gestational age 26 weeks and 0 days
Pelvic organ prolapse (POP) incidence, in the 3rd trimester of pregnancy
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).
Time frame: At the follow-up at gestational age 36 weeks and 0 days
Pelvic organ prolapse (POP) incidence at 6 weeks postpartum
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).
Time frame: At the follow-up at 6 weeks postpartum
Pelvic organ prolapse (POP) incidence at 3 months postpartum
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).
Time frame: At the follow-up at 3 months postpartum
Pelvic organ prolapse (POP) incidence at 6 months postpartum
Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).
Time frame: At the follow-up at 6 months postpartum
Length of the second stage of delivery
Length in minutes (minimum 0 - maximum 300 minutes).
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Delivery mode
Vaginal, planned or unplanned Caesarean.
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Foetal position
Cephalic regular (occiput anterior), cephalic occiput posterior or breech
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Episiotomy
Yes or no
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum
Perineal tear
Yes or no; if yes - tear degree (1st, 2nd, 3rd (3a, 3b, 3c), 4th)
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Instrumental delivery
Yes or no; if yes - type (vacuum assisted or forceps)
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Length of the first stage of delivery
Length in minutes (minimum 0 - no maximum)
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Fidelity of PFMT
Self-reported training frequency (from 0 to 4 times a week)
Time frame: The questionnaire is filled every week from baseline to 6 months postpartum
Other implementation outcomes: acceptability, feasibility, appropriateness
Will be collected through short interviews
Time frame: At study completion
Plan to share: No
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University of Southern Denmark