Examining the link between pelvic changes and postpartum urinary incontinence
Correlation Between the Change in the Antero-posterior Diameter of the Pelvic Side and the Incidence of Post-partum Urinary Incontinence
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06812806
This study is trying to see how changes in pelvic floor muscles during pregnancy affect urinary incontinence after childbirth and whether perineal exercises can help improve symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06812806 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how changes in the pelvic floor muscles during pregnancy relate to the incidence of postpartum urinary incontinence. Using transperineal ultrasound, researchers will measure the pelvic floor's contractile capacity and assess the impact of perineal exercises on urinary incontinence symptoms. Participants will complete a validated questionnaire to evaluate their urinary incontinence severity and quality of life. The study aims to gather data on various factors, including delivery method and maternal health, to better understand the condition.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have recently delivered via vaginal or cesarean methods.
Not a fit: Patients with severe maternal complications or infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and management strategies for postpartum urinary incontinence.
How similar studies have performed: While similar studies have explored pelvic floor dynamics, this specific correlation is less commonly investigated, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
- Email: aly.youssef@aosp.bo.it
- Phone: 0512144412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Urinary Incontinence, incontinence