Postpartum Urinary IncontinenceNCT06812806
Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence
An observational study of Postpartum Urinary Incontinence, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
During pregnancy, the strength of the pelvic floor muscles may decrease, which can lead to musculoskeletal changes that may facilitate the onset of urinary incontinence. The investigators decided to conduct this study firstly to analyze, through simple ultrasound indices, how the contractile capacity of the pelvic… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Urinary Incontinence
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2021to 31 Dec 2027
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants who have given birth by vaginal delivery, obstetric suction, or cesarean section and who result exclusively in inpatient care during puerperium.
Who may be able to join
- age of 18 years or older
- completion of delivery by vaginal delivery, vaginal delivery with obstetric suction cup or cesarean section
- acquisition of informed consent form
Who cannot join
- presence of severe maternal complications (e.g., ongoing postpartum hemorrhage, severe sepsis, pulmonary embolism, heart failure).
- presence of clinically demonstrable vulvar or vaginal infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, 0512144412, aly.youssef@aosp.bo.it
About this study
During pregnancy, the strength of the pelvic floor muscles may decrease, which can lead to musculoskeletal changes that may facilitate the onset of urinary incontinence. The investigators decided to conduct this study firstly to analyze, through simple ultrasound indices, how the contractile capacity of the pelvic floor muscles affects postpartum urinary incontinence; secondly to study the correlation between the use of perineal gymnastics, the incidence of postpartum urinary incontinence, and the strength of floor contraction.
Read the detailed description
As part of the gynecologic ultrasound that is routinely performed, a transperineal scan will be performed, at rest and during maximal contraction to measure the lower portion of the pelvic floor groove. I order tho achieve this, doctors will illustrate to participants first verbally and then with the visual aid of the ultrasound monitor, how to contract the pelvic floor muscles. Transperineal ultrasound is performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora. Such ultrasound does not involve internal investigations and is in no way painful. The duration of the additional ultrasound scan involves a few minutes. In addition, in order to assess the presence of typical symptoms of urinary incontinence, the participant will undergo a standardized validated questionnaire in the Italian language, called ICIQ-UI SF, consisting of a series of questions that will investigate the type of urinary incontinence, its severity and its impact on her quality of life in the four weeks prior to administration. After delivery, the participant's medical records will be consulted and some data regarding the participant (age, ethnicity, height, weight, BMI, parity, gestational age at the time of delivery), the delivery (duration of stage II labor, mode of delivery, any vagino-perineal laceration and its degree) and the newborn (weight and head circumference measurement) will be recorded.
- Conditions
- Postpartum Urinary Incontinence
- Keywords
- incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the correlation between the proportional change in antero-posterior diameter of the pelvic hiatus and the incidence of postpartum urinary incontinence
Evaluation of the correlation between the proportional change (in percentage) in pelvic antero-posterior diameter (APD) between rest and maximal contraction of pelvic floor muscles and the incidence of postpartum urinary incontinence
Measured: On the second day, after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start17 Dec 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812806
- Sponsor's protocol ID
- APD.IUP
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06812806
- Acronym / sponsor ID
- APD.IUP
- Conditions
- Postpartum Urinary Incontinence
- Keywords
- incontinence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 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.
During pregnancy, the strength of the pelvic floor muscles may decrease, which can lead to musculoskeletal changes that may facilitate the onset of urinary incontinence. The investigators decided to conduct this study firstly to analyze, through simple ultrasound indices, how the contractile capacity of the pelvic floor muscles affects postpartum urinary incontinence; secondly to study the correlation between the use of perineal gymnastics, the incidence of postpartum urinary incontinence, and the strength of floor contraction.
Detailed description
As part of the gynecologic ultrasound that is routinely performed, a transperineal scan will be performed, at rest and during maximal contraction to measure the lower portion of the pelvic floor groove. I order tho achieve this, doctors will illustrate to participants first verbally and then with the visual aid of the ultrasound monitor, how to contract the pelvic floor muscles. Transperineal ultrasound is performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora. Such ultrasound does not involve internal investigations and is in no way painful. The duration of the additional ultrasound scan involves a few minutes. In addition, in order to assess the presence of typical symptoms of urinary incontinence, the participant will undergo a standardized validated questionnaire in the Italian language, called ICIQ-UI SF, consisting of a series of questions that will investigate the type of urinary incontinence, its severity and its impact on her quality of life in the four weeks prior to administration. After delivery, the participant's medical records will be consulted and some data regarding the participant (age, ethnicity, height, weight, BMI, parity, gestational age at the time of delivery), the delivery (duration of stage II labor, mode of delivery, any vagino-perineal laceration and its degree) and the newborn (weight and head circumference measurement) will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants who have given birth by vaginal delivery, obstetric suction, or cesarean section and who result exclusively in inpatient care during puerperium.
Key inclusion criteria (3 listed)
- age of 18 years or older
- completion of delivery by vaginal delivery, vaginal delivery with obstetric suction cup or cesarean section
- acquisition of informed consent form
Key exclusion criteria (2 listed)
- presence of severe maternal complications (e.g., ongoing postpartum hemorrhage, severe sepsis, pulmonary embolism, heart failure).
- presence of clinically demonstrable vulvar or vaginal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the correlation between the proportional change in antero-posterior diameter of the pelvic hiatus and the incidence of postpartum urinary incontinence
Time frame: On the second day, after delivery
Evaluation of the correlation between the proportional change (in percentage) in pelvic antero-posterior diameter (APD) between rest and maximal contraction of pelvic floor muscles and the incidence of postpartum urinary incontinence
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 6 Feb 2025.
Related trials for Postpartum Urinary Incontinence
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Comparative Effects of Hypopressive and Transverses Abdominis Focused Core Training in Postpartum
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MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.
Stress Urinary Incontinence
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Comparative Effects of Hypopressive Exercises and Paula Method in Postpartum Women.
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The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation
Urinary Incontinence, Pelvic Organ Prolapse (POP)
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The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial
Stress Urinary Incontinence (SUI)
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.
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Urinary Incontinence, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 inclusion and 2 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 6 Feb 2025. 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 Italy. 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. 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 Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD (0512144412, aly.youssef@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the correlation between the proportional change in antero-posterior diameter of the pelvic hiatus and the incidence of postpartum urinary incontinence (time frame: On the second day, after delivery). 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 6 Feb 2025.