Bladder Displacement During Abdominal and Pelvic Floor Exercises

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

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

Study Overview

• Status: Unknown
• Conditions: Postpartum Disorder
• Intervention / Treatment: Other: Pelvic Floor and Abdominal Exercises

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Spain
  • Castilla La Mancha
    • Toledo, Castilla La Mancha, Spain, 45071
      • University of Castilla-La Mancha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

participants were recruited at the midwife consultation from a Primary Care Health center.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
postpartum women with no pelvic floor disorders; This group realised a set of 6 abdominal and pelvic floor exercises, with a muscle recruitment of 25% of maximum force. Exercise A: Pelvic Floor contraction Exercise B: Pelvic Floor and Deep Abdominal muscles contraction Exercise C: Pelvic Floor, Deep Abdominal muscles contraction, and axial Stretching Exercise D: Pelvic Floor, Deep and Superficial Abdominal muscles contraction Exercise E: Abdominal Crunch Exercise Exercise F: Low pressure Abdominal Exercise The correct muscle contraction execution was controlled by superficial pelvic floor and abdominal electromyography. The bladder base and neck displacement was registered by Transabdominal Ultrasound (TAUS) and Transperineal Ultrasound (TPUS) respectively. To image the bladder base and the bladder neck a 3.5 MHz (megahertz) curved linear array ultrasound transducer was used (LOGIQe Ultrasound,General Electric Healthcare, USA) with the ultrasound unit set in B mode.	Other: Pelvic Floor and Abdominal Exercises; two repetitions of each exercise, during exhalation phase
nulliparous women with no pelvic floor disorders; This group realised a set of 6 abdominal and pelvic floor exercises, with a muscle recruitment of 25% of maximum force. Exercise A: Pelvic Floor contraction Exercise B: Pelvic Floor and Deep Abdominal muscles contraction Exercise C: Pelvic Floor, Deep Abdominal muscles contraction, and axial Stretching Exercise D: Pelvic Floor, Deep and Superficial Abdominal muscles contraction Exercise E: Abdominal Crunch Exercise Exercise F: Low pressure Abdominal Exercise The correct muscle contraction execution was controlled by superficial pelvic floor and abdominal electromyography. The bladder base and neck displacement was registered by Transabdominal Ultrasound (TAUS) and Transperineal Ultrasound (TPUS) respectively. To image the bladder base and the bladder neck a 3.5 MHz (megahertz)curved linear array ultrasound transducer was used (LOGIQe Ultrasound,GE eneral Electric Healthcare, USA) with the ultrasound unit set in B mode.	Other: Pelvic Floor and Abdominal Exercises; two repetitions of each exercise, during exhalation phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Investigators: Principal Investigator: Sandra M Martinez, PHD student, University of A Coruña. Faculty of Physiotherapy, Spain

Publications and helpful links

General Publications

• 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. doi: 10.1007/s00192-006-0225-4. Epub 2006 Oct 17.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): October 14, 2019
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: postpartum; ultrasonography; pelvic floor; abdominal muscles
• Additional Relevant MeSH Terms: Pregnancy Complications; Puerperal Disorders
• Other Study ID Numbers: 2014/610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All the individual participant data that underlie results in a publication
• IPD Sharing Time Frame: The data will be available within 6 months after study completion
• IPD Sharing Access Criteria: Data access will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No