Bladder Displacement During Abdominal and Pelvic Floor Exercises

NCT04154527 | Unknown

• 1 other identifier: 2014/610
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postpartum Disorder

Keywords

pelvic floor; abdominal muscles; ultrasonography; postpartum

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Pelvic Floor and Abdominal Exercises OTHER

two repetitions of each exercise, during exhalation phase

nulliparous women with no pelvic floor disorders; postpartum women with no pelvic floor disorders

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• pregnancy
• caesarean birth
• pelvic Floor disorders
• neurological diseases

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla-La Mancha

Toledo, Castille-La Mancha, 45071, Spain

Location

Related Publications (2)

• 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.

  PMID: 17043739 BACKGROUND

• 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.

  PMID: 26215905 BACKGROUND

MeSH Terms

Conditions

Puerperal Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sandra M Martinez, PHD student

  University of A Coruña. Faculty of Physiotherapy, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 6, 2019
• Study Start: May 2, 2017
• Primary Completion: October 14, 2019
• Study Completion: November 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available within 6 months after study completion
• Access Criteria: Data access will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement

Locations

ES (1)