Bladder Displacement During Abdominal and Pelvic Floor Exercises

Postpartum Disorder Clinical Trial

Official title:

Bladder Base Displacement During Abdominal and Pelvic Floor Exercises in Postpartum Women Comparing to Nulliparous Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04154527
• Other study ID #: 2014/610
• Status: Enrolling by invitation
• Start date: May 2, 2017
• Est. completion date: November 2020

Study information

• Verified date: March 2020
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the bladder base displacements during abdominal and pelvic floor exercises in postpartum women comparing to nulliparous women

Description:

Postpartum women are at increased risk of suffering pelvic floor dysfunctions. However, only a few researches are focused on the exercises physiological effect at the postpartum recovery period.

A prospective observational study was designed to evaluate the protective or the prolapsed effect of abdominal and pelvic floor exercises in postpartum women.

Two groups were established: Group A was composed of primiparous women during postpartum period and group B of nulliparous women. Both groups practiced the same set of 6 abdominal and perineum exercises. The bladder descent was registered by ultrasonography, and the correct execution was controlled in both groups by superficial pelvic floor and abdominal electromyography.

A Graphical User Interface on MATLAB software has been developed for aiding in offline measurement process.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: November 2020
• Est. primary completion date: October 14, 2019
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• women at postpartum period (more than 6 and less than 12 weeks after vaginal birth)

• willingness to participate in the study

• ability to contract Pelvic Floor Muscles correctly

• written consent to participate.

Exclusion Criteria:

• pregnancy

• caesarean birth

• pelvic Floor disorders

• neurological diseases

Related Conditions & MeSH terms

• Postpartum Disorder
• Puerperal Disorders

Intervention

Other:
• Pelvic Floor and Abdominal Exercises
two repetitions of each exercise, during exhalation phase

Locations

Country	Name	City	State
Spain	University of Castilla-La Mancha	Toledo	Castilla La Mancha

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Barton A, Serrao C, Thompson J, Briffa K. Transabdominal ultrasound to assess pelvic floor muscle performance during abdominal curl in exercising women. Int Urogynecol J. 2015 Dec;26(12):1789-95. doi: 10.1007/s00192-015-2791-9. Epub 2015 Jul 28. — View Citation

Thompson JA, O'Sullivan PB, Briffa NK, Neumann P. Comparison of transperineal and transabdominal ultrasound in the assessment of voluntary pelvic floor muscle contractions and functional manoeuvres in continent and incontinent women. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Jul;18(7):779-86. Epub 2006 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cranial or Caudal bladder base displacement measured in cm during the set of 6 exercises.	Cranial or Caudal bladder base displacement during pelvic floor and abdominal exercises, comparing the baseline at rest to the position at 25% of muscle recruitment, in each exercise.	between 6 and 12 weeks after birth
Primary	Vertical and horizontal bladder neck displacement measured in cm during the set of 6 exercises.	Vertical and horizontal displacement of the bladder neck during pelvic floor and abdominal exercises, comparing the baseline at rest to the position at 25% of muscle recruitment in each exercise.	between 6 and 12 weeks after birth