Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse, Sexual Dysfunction, Pelvic Floor Disorder
Conditions
Keywords
Pelvic floor muscle training, Pregnancy, Nulliparous women, urinary incontinence, Pelvic floor disorders, sexual function, obstetric outcomes, implementation, Randomised controlled trial
Brief summary
The project seeks to investigate effectiveness of PFMT during pregnancy.
Detailed description
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 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 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.
Interventions
BEHAVIORALPFMT
A structured home-based pelvic floor muscle training programme consisting of progressive pelvic floor muscle exercises, training reminders as well as supportive information with educational materials and habit-building strategies. Participants are advised to perform pelvic floor muscle training three to five times per week during pregnancy and continue after birth.
BEHAVIORALStandard care
Routine antenatal care provided according to local clinical practice. This may include general information about pelvic floor muscle training but does not include access to the study programme, study application, structured training support, or study-specific reminders.
Sponsors
University of Southern Denmark
Kolding Sygehus
Esbjerg Hospital - University Hospital of Southern Denmark
Odense University Hospital
Hospital Sønderjylland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* up to 12+6 weeks of gestation to receive invitation and up to 16+0 weeks of gestation to be enrolled * Para 0 (no previous birth or pregnancy \> 16 weeks of gestation) * Understands, writes, and reads fluently in Danish or English * Has a smart phone or computer/tablet to reach the training program
Exclusion criteria
* Severe psychiatric illness (e.g. schizophrenia, bipolar disorder, severe depression or anxiety) * Active substance abuse * Acute social crises (e.g. homelessness, ongoing domestic violence, severe financial instability, lack of social support) * Women with limited capacity to provide informed consent (due to cognitive impairment or language barriers) * Previous pregnancy of \> 16 weeks of gestation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence of urinary incontinence (UI) at 3 months postpartum | At 3 months follow-up after giving birth | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score \> 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The presence of urinary incontinence at inclusion | At baseline: inclusion | ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome) |
| Urinary incontinence severity at inclusion | At baseline: inclusion | ICIQ-UI SF score between 0-21. Outcome is continuous |
| The presence of urinary incontinence at the 2nd trimester of pregnancy | At follow-up gestational age 26 weeks and 0 days | ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome) |
| Urinary incontinence severity at the 2nd trimester of pregnancy | At follow-up gestational age 26 weeks and 0 days | ICIQ-UI SF score between 0-21. Outome is continuous |
| The presence of urinary incontinence at the 3rd trimester of pregnancy | At follow-up gestational age 36 weeks and 0 days | ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome) |
| Urinary incontinence severity at the 3rd trimester of pregnancy | At follow-up gestational age 36 weeks and 0 days | ICIQ-UI SF score between 0-21. Outcome is continuous |
| The presence of urinary incontinence at 6 months postpartum | At follow-up at 6 months postpartum | ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary |
| UI severity at 6 months postpartum | At follow-up at 6 months postpartum | IICIQ-UI SF score between 0-21. Outcome is continuous |
| The presence of anal incontinence (AI) at inclusion | At baseline: inclusion | 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). Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11) |
| Colorectal-anal symptoms severity at inclusion | At baseline: inclusion | Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity |
| The presence of anal incontinence (AI) in the 2nd trimester of pregnancy | At follow-up gestational age 26 weeks and 0 days | Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11) |
| Colorectal-anal symptoms severity 2nd trimester of pregnancy | At follow-up gestational age 26 weeks and 0 days | Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity |
| The presence of anal incontinence (AI) in the 3rd trimester of pregnancy | At follow-up gestational age 36 weeks and 0 days | Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11) |
| Colorectal-anal symptoms severity 3rd trimester of pregnancy | At follow-up at gestational age 36 weeks and 0 days | Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity |
| The presence of anal incontinence (AI) at 3 months postpartum | At follow-up 3 months postpartum | Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11) |
| Colorectal-anal symptoms severity 3 months postpartum | At follow-up 3 months postpartum | Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity |
| The presence of anal incontinence (AI) at 6 months postpartum | At follow-up 6 months postpartum | Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11) |
| Colorectal-anal symptoms severity 6 months postpartum | At the follow-up at 6 months postpartum | Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity |
| The presence of sexual dysfunction at inclusion | At baseline: inclusion | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19 |
| Sexual dysfunction severity at inclusion | At baseline: inclusion | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous |
| The presence of sexual dysfunction at inclusion, during the 2nd trimester of pregnancy | At follow-up at gestational age 26 weeks and 0 days | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19 |
| Sexual dysfunction severity at inclusion, during the 2nd trimester of pregnancy | At follow-up gestational Age 26 weeks and 0 days | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning |
| The presence of sexual dysfunction at inclusion, during the 3rd trimester of pregnancy | At follow-up at gestational Age 36 weeks and 0 days | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19 |
| Sexual dysfunction severity at inclusion, during the 3rd trimester of pregnancy | At follow-up gestational Age 36 weeks and 0 days | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning |
| The presence of sexual dysfunction at 3 month postpartum | At the follow-up at 3 month postpartum | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19. Lower scores indicate poorer sexual functioning |
| Sexual dysfunction severity at 3 month postpartum | At the follow-up at 3 month postpartum | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning |
| The presence of sexual dysfunction at 6month postpartum | At the follow-up at 6 month postpartum | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19. Lower scores indicate poorer sexual functioning |
| Sexual dysfunction severity at 6months postpartum | At the follow-up at 6 month postpartum | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning |
| The presence of pelvic organ prolapse (POP) symptoms at inclusion | At baseline: inclusion | 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). Outcome defined if POPDI-6 score \> 0 |
| Pelvic organ prolapse (POP) symptoms severity at inclusion | At baseline: inclusion | 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). Outcome is continuous |
| The presence of pelvic organ prolapse (POP) symptoms, in the 2nd trimester of pregnancy | At follow-up gestational age 26 weeks and 0 days | 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). Outcome defined if POPDI-6 score \> 0 |
| Pelvic organ prolapse (POP) symptoms severity, in the 2nd trimester of pregnancy | At follow-up gestational age 26 weeks and 0 days | 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). Outcome is continuous |
| The presence of pelvic organ prolapse (POP) symptoms, in the 3rd trimester of pregnancy | At the follow-up at gestational age 36 weeks and 0 days | 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). Outcome defined if POPDI-6 score \> 0 |
| Pelvic organ prolapse (POP) symptoms severity, in the 3rd trimester of pregnancy | At the follow-up at gestational age 36 weeks and 0 days | 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). Outcome is continuous |
| The presence of pelvic organ prolapse (POP) symptoms at 3 months postpartum | At the follow-up 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). Outcome defined if POPDI-6 score \> 0 |
| Pelvic organ prolapse (POP) symptoms severity at 3 months postpartum | At the follow-up 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). Outcome is continuous |
| The presence of pelvic organ prolapse (POP) symptoms at 6 months postpartum | At the follow-up 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). Outcome defined if POPDI-6 score \> 0 |
| Pelvic organ prolapse (POP) symptoms severity at 6 months postpartum | At the follow-up 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). Outcome is continuous |
| Delivery mode | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. | Outcome is defined as categorical: vaginal, planned cesarean, emergency cesarean |
| Foetal position | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. | Cephalic regular (occiput anterior), cephalic occiput posterior or breech. Outcome is categorical |
| Episiotomy | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum | Yes or no. Outcome is binary |
| Perineal tear | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. | Yes or no; if yes - tear degree (1st, 2nd, 3rd (3a, 3b, 3c), 4th). Outcome is categorical |
| Instrumental delivery | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. | Yes or no; if yes - type (vacuum assisted or forceps). Outcome is binary |
| Fidelity of PFMT | The questionnaire is filled every week from baseline to 6 months postpartum | Self-reported training frequency (0 times, 1-2 times, 3-4 times or more per week) |
| Implementation outcomes | At study completion | Collected through short interviews |
| Proportion of participants reporting capability-, opportunity-, and motivation-related barriers and facilitators for pelvic floor muscle training. | at the follow-up at gestational age 36 weeks and 0 days | Capability, Opportunity and Motivation (COM-B) related to pelvic floor muscle training, assessed using a study-specific COM-B Self-Evaluation Questionnaire. Participants may select one or more response options within the domains of capability, opportunity, and motivation. Participants may select one or more response options within the domains of capability, opportunity, and motivation. Responses are analysed as individual items (selected/not selected), and no total score is calculated. Therefore, minimum and maximum values are not applicable. A higher frequency of endorsement of a specific item indicates a greater perceived barrier, need, or facilitator related to pelvic floor muscle training. |
| Length of the first stage of delivery | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. | Length in minutes (minimum 0 - no maximum) |
| Length of the passive second stage of delivery | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. | Outcome is continuous and Length in minutes (minimum 0 - maximum 300 minutes). |
| Length of the active second stage of delivery | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. | Outcome is continuous and Length in minutes (minimum 0 - maximum 300 minutes). |
Countries
Denmark
Contacts
CONTACTGreta Puriene
CONTACTChristina Prinds
PRINCIPAL_INVESTIGATORGreta Puriene
Hospital Sønderjylland
Outcome results
None listed