Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence

February 3, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Recruiting

Conditions

Postpartum Urinary Incontinence

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 Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
Phone Number: 0512144412
Email: aly.youssef@aosp.bo.it

Study Locations

Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Contact:
      
      Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
      
      Phone Number: 0512144412
      
      Email: aly.youssef@aosp.bo.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants who have given birth by vaginal delivery, obstetric suction, or cesarean section and who result exclusively in inpatient care during puerperium.

Description

Inclusion Criteria:

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

Exclusion Criteria:

presence of severe maternal complications (e.g., ongoing postpartum hemorrhage, severe sepsis, pulmonary embolism, heart failure).
presence of clinically demonstrable vulvar or vaginal infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	On the second day, after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)