Urinary IncontinenceNCT07104292
Pelvic Floor Muscle Training During Pregnancy
A study testing PFMT in people with Urinary Incontinence and Anal Incontinence, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The project seeks to investigate effectiveness of PFMT during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse
- What is being tested?
- PFMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 804 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Oct 2025to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Sygehus Sønderjylland
Aabenraa, Southern Denmark, 6200
About this study
Official title: Antenatal Pelvic Floor Muscle Training in Nulliparous Women: A Hybrid Type 1 Randomised Controlled Trial
The project seeks to investigate effectiveness of PFMT during pregnancy.
Read the 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.
- Conditions
- Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse, Sexual Dysfunction, Pelvic Floor Disorder
- Being tested
- PFMT, Standard care
- Keywords
- Pelvic floor muscle training, Pregnancy, Nulliparous women, urinary incontinence, Pelvic floor disorders, sexual function, obstetric outcomes, implementation, Randomised controlled trial
- Medical subject headings
- Urinary Incontinence, Encopresis, Pelvic Organ Prolapse, Sexual Dysfunction, Physiological, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMTBehavioural
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.
Standard careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Experimental | Participants receive access to the pelvic floor muscle training programme in addition to usual antenatal care. The programme is delivered through a mobile application and supporting materials is sent out. Receives: Behavioral: PFMT |
| Standard care | Placebo comparator | The control group will receive routine care - recommendation to do the training without any further instructions. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of urinary incontinence (UI) at 3 months postpartum
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score > 0.
Measured: At 3 months follow-up after giving birth
Secondary outcomes (49)
The presence of urinary incontinence at inclusion
ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score > 0) (binary outcome)
Measured: At baseline: inclusion
Urinary incontinence severity at inclusion
ICIQ-UI SF score between 0-21. Outcome is continuous
Measured: At baseline: inclusion
The presence of urinary incontinence at the 2nd trimester of pregnancy
ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score > 0) (binary outcome)
Measured: At follow-up gestational age 26 weeks and 0 days
Urinary incontinence severity at the 2nd trimester of pregnancy
ICIQ-UI SF score between 0-21. Outome is continuous
Measured: At follow-up gestational age 26 weeks and 0 days
The presence of urinary incontinence at the 3rd trimester of pregnancy
ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score > 0) (binary outcome)
Measured: At follow-up gestational age 36 weeks and 0 days
Urinary incontinence severity at the 3rd trimester of pregnancy
ICIQ-UI SF score between 0-21. Outcome is continuous
Measured: At follow-up gestational age 36 weeks and 0 days
The presence of urinary incontinence at 6 months postpartum
ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score > 0) (binary
Measured: At follow-up at 6 months postpartum
UI severity at 6 months postpartum
IICIQ-UI SF score between 0-21. Outcome is continuous
Measured: At follow-up at 6 months postpartum
The presence of anal incontinence (AI) at 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)
Measured: At baseline: inclusion
Colorectal-anal symptoms severity at inclusion
Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity
Measured: At baseline: inclusion
The presence of anal incontinence (AI) in the 2nd trimester of pregnancy
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)
Measured: At follow-up gestational age 26 weeks and 0 days
Colorectal-anal symptoms severity 2nd trimester of pregnancy
Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity
Measured: At follow-up gestational age 26 weeks and 0 days
The presence of anal incontinence (AI) in the 3rd trimester of pregnancy
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)
Measured: At follow-up gestational age 36 weeks and 0 days
Colorectal-anal symptoms severity 3rd trimester of pregnancy
Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity
Measured: At follow-up at gestational age 36 weeks and 0 days
The presence of anal incontinence (AI) at 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)
Measured: At follow-up 3 months postpartum
Colorectal-anal symptoms severity 3 months postpartum
Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity
Measured: At follow-up 3 months postpartum
The presence of anal incontinence (AI) at 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)
Measured: At follow-up 6 months postpartum
Colorectal-anal symptoms severity 6 months postpartum
Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity
Measured: At the follow-up at 6 months postpartum
The presence of sexual dysfunction at inclusion
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19
Measured: At baseline: inclusion
Sexual dysfunction severity at inclusion
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous
Measured: At baseline: inclusion
The presence of sexual dysfunction at inclusion, during the 2nd trimester of pregnancy
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19
Measured: At follow-up at gestational age 26 weeks and 0 days
Sexual dysfunction severity at inclusion, during the 2nd trimester of pregnancy
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning
Measured: At follow-up gestational Age 26 weeks and 0 days
The presence of sexual dysfunction at inclusion, during the 3rd trimester of pregnancy
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19
Measured: At follow-up at gestational Age 36 weeks and 0 days
Sexual dysfunction severity at inclusion, during the 3rd trimester of pregnancy
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning
Measured: At follow-up gestational Age 36 weeks and 0 days
The presence of sexual dysfunction 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
Measured: At the follow-up at 3 month postpartum
Sexual dysfunction severity 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
Measured: At the follow-up at 3 month postpartum
The presence of sexual dysfunction at 6month 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
Measured: At the follow-up at 6 month postpartum
Sexual dysfunction severity at 6months postpartum
Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning
Measured: At the follow-up at 6 month postpartum
The presence of pelvic organ prolapse (POP) symptoms at 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
Measured: At baseline: inclusion
Pelvic organ prolapse (POP) symptoms severity at 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
Measured: At baseline: inclusion
The presence of pelvic organ prolapse (POP) symptoms, 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). Outcome defined if POPDI-6 score > 0
Measured: At follow-up gestational age 26 weeks and 0 days
Pelvic organ prolapse (POP) symptoms severity, 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). Outcome is continuous
Measured: At follow-up gestational age 26 weeks and 0 days
The presence of pelvic organ prolapse (POP) symptoms, 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). Outcome defined if POPDI-6 score > 0
Measured: At the follow-up at gestational age 36 weeks and 0 days
Pelvic organ prolapse (POP) symptoms severity, 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). Outcome is continuous
Measured: At the follow-up at gestational age 36 weeks and 0 days
The presence of pelvic organ prolapse (POP) symptoms 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
Measured: At the follow-up at 3 months postpartum
Pelvic organ prolapse (POP) symptoms severity 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
Measured: At the follow-up at 3 months postpartum
The presence of pelvic organ prolapse (POP) symptoms 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
Measured: At the follow-up at 6 months postpartum
Pelvic organ prolapse (POP) symptoms severity 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
Measured: At the follow-up at 6 months postpartum
Delivery mode
Outcome is defined as categorical: vaginal, planned cesarean, emergency cesarean
Measured: 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. Outcome is categorical
Measured: 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. Outcome is binary
Measured: 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). Outcome is categorical
Measured: 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). Outcome is binary
Measured: 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 (0 times, 1-2 times, 3-4 times or more per week)
Measured: The questionnaire is filled every week from baseline to 6 months postpartum
Implementation outcomes
Collected through short interviews
Measured: At study completion
Proportion of participants reporting capability-, opportunity-, and motivation-related barriers and facilitators for pelvic floor muscle training.
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.
Measured: at the follow-up at gestational age 36 weeks and 0 days
Length of the first stage of delivery
Length in minutes (minimum 0 - no maximum)
Measured: 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 passive second stage of delivery
Outcome is continuous and Length in minutes (minimum 0 - maximum 300 minutes).
Measured: 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 active second stage of delivery
Outcome is continuous and Length in minutes (minimum 0 - maximum 300 minutes).
Measured: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start27 Oct 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 804 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus, Esbjerg Hospital - University Hospital of Southern Denmark, Odense University Hospital, Hospital Sønderjylland
- Responsible party
- Sponsor
- Investigators
- Greta Puriene, Principal investigator, Hospital Sønderjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104292
- Sponsor's protocol ID
- SHS-KS-06-2025
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Pelvic Floor Muscle Training in Nulliparous Women: A Hybrid Type 1 Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07104292
- Acronym / sponsor ID
- SHS-KS-06-2025
- Conditions
- Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse, Sexual Dysfunction, Pelvic Floor Disorder
- Keywords
- Pelvic floor muscle training, Pregnancy, Nulliparous women, urinary incontinence, Pelvic floor disorders, sexual function, obstetric outcomes, implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 804 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Kolding Sygehus, Esbjerg Hospital - University Hospital of Southern Denmark, Odense University Hospital, Hospital Sønderjylland
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Experimental | Behavioral: PFMTParticipants receive access to the pelvic floor muscle training programme in addition to usual antenatal care. The programme is delivered through a mobile application and supporting materials is sent out. |
| Standard care | Placebo comparator | Behavioral: Standard careThe control group will receive routine care - recommendation to do the training without any further instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFMTA 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. | Behavioural | Pelvic Floor Muscle Training (PFMT) |
| Standard careRoutine 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. | Behavioural | Standard care |
Primary outcome
The presence of urinary incontinence (UI) at 3 months postpartum
Time frame: At 3 months follow-up after giving birth
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score > 0.
49 secondary outcomes
The presence of urinary incontinence at inclusion
Time frame: At baseline: inclusion
Urinary incontinence severity at inclusion
Time frame: At baseline: inclusion
The presence of urinary incontinence at the 2nd trimester of pregnancy
Time frame: At follow-up gestational age 26 weeks and 0 days
Urinary incontinence severity at the 2nd trimester of pregnancy
Time frame: At follow-up gestational age 26 weeks and 0 days
The presence of urinary incontinence at the 3rd trimester of pregnancy
Time frame: At follow-up gestational age 36 weeks and 0 days
Urinary incontinence severity at the 3rd trimester of pregnancy
Time frame: At follow-up gestational age 36 weeks and 0 days
The presence of urinary incontinence at 6 months postpartum
Time frame: At follow-up at 6 months postpartum
UI severity at 6 months postpartum
Time frame: At follow-up at 6 months postpartum
The presence of anal incontinence (AI) at inclusion
Time frame: At baseline: inclusion
Colorectal-anal symptoms severity at inclusion
Time frame: At baseline: inclusion
The presence of anal incontinence (AI) in the 2nd trimester of pregnancy
Time frame: At follow-up gestational age 26 weeks and 0 days
Colorectal-anal symptoms severity 2nd trimester of pregnancy
Time frame: At follow-up gestational age 26 weeks and 0 days
The presence of anal incontinence (AI) in the 3rd trimester of pregnancy
Time frame: At follow-up gestational age 36 weeks and 0 days
Colorectal-anal symptoms severity 3rd trimester of pregnancy
Time frame: At follow-up at gestational age 36 weeks and 0 days
The presence of anal incontinence (AI) at 3 months postpartum
Time frame: At follow-up 3 months postpartum
Colorectal-anal symptoms severity 3 months postpartum
Time frame: At follow-up 3 months postpartum
The presence of anal incontinence (AI) at 6 months postpartum
Time frame: At follow-up 6 months postpartum
Colorectal-anal symptoms severity 6 months postpartum
Time frame: At the follow-up at 6 months postpartum
The presence of sexual dysfunction at inclusion
Time frame: At baseline: inclusion
Sexual dysfunction severity at inclusion
Time frame: At baseline: inclusion
The presence of sexual dysfunction at inclusion, during the 2nd trimester of pregnancy
Time frame: At follow-up at gestational age 26 weeks and 0 days
Sexual dysfunction severity at inclusion, during the 2nd trimester of pregnancy
Time frame: At follow-up gestational Age 26 weeks and 0 days
The presence of sexual dysfunction at inclusion, during the 3rd trimester of pregnancy
Time frame: At follow-up at gestational Age 36 weeks and 0 days
Sexual dysfunction severity at inclusion, during the 3rd trimester of pregnancy
Time frame: At follow-up gestational Age 36 weeks and 0 days
The presence of sexual dysfunction at 3 month postpartum
Time frame: At the follow-up at 3 month postpartum
Sexual dysfunction severity at 3 month postpartum
Time frame: At the follow-up at 3 month postpartum
The presence of sexual dysfunction at 6month postpartum
Time frame: At the follow-up at 6 month postpartum
Sexual dysfunction severity at 6months postpartum
Time frame: At the follow-up at 6 month postpartum
The presence of pelvic organ prolapse (POP) symptoms at inclusion
Time frame: At baseline: inclusion
Pelvic organ prolapse (POP) symptoms severity at inclusion
Time frame: At baseline: inclusion
The presence of pelvic organ prolapse (POP) symptoms, in the 2nd trimester of pregnancy
Time frame: At follow-up gestational age 26 weeks and 0 days
Pelvic organ prolapse (POP) symptoms severity, in the 2nd trimester of pregnancy
Time frame: At follow-up gestational age 26 weeks and 0 days
The presence of pelvic organ prolapse (POP) symptoms, in the 3rd trimester of pregnancy
Time frame: At the follow-up at gestational age 36 weeks and 0 days
Pelvic organ prolapse (POP) symptoms severity, in the 3rd trimester of pregnancy
Time frame: At the follow-up at gestational age 36 weeks and 0 days
The presence of pelvic organ prolapse (POP) symptoms at 3 months postpartum
Time frame: At the follow-up at 3 months postpartum
Pelvic organ prolapse (POP) symptoms severity at 3 months postpartum
Time frame: At the follow-up at 3 months postpartum
The presence of pelvic organ prolapse (POP) symptoms at 6 months postpartum
Time frame: At the follow-up at 6 months postpartum
Pelvic organ prolapse (POP) symptoms severity at 6 months postpartum
Time frame: At the follow-up at 6 months postpartum
Delivery mode
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
Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Greta Puriene principal investigator
Hospital Sønderjylland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT in people with Urinary Incontinence and Anal Incontinence, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greta Puriene (+4571638335, greta.puriene@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of urinary incontinence (UI) at 3 months postpartum (time frame: At 3 months follow-up after giving birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.