Bladder Displacement During Abdominal and Pelvic Floor Exercises

Sponsor
University of Castilla-La Mancha (Other)
Overall Status
Unknown status
CT.gov ID
NCT04154527
Collaborator
(none)
64
1
42
1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
64 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Bladder Base Displacement During Abdominal and Pelvic Floor Exercises in Postpartum Women Comparing to Nulliparous Women
Actual Study Start Date :
May 2, 2017
Actual Primary Completion Date :
Oct 14, 2019
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cranial or Caudal bladder base displacement measured in cm during the set of 6 exercises. [between 6 and 12 weeks after birth]

    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.

  2. Vertical and horizontal bladder neck displacement measured in cm during the set of 6 exercises. [between 6 and 12 weeks after birth]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Castilla-La Mancha Toledo Castilla La Mancha Spain 45071

Sponsors and Collaborators

  • University of Castilla-La Mancha

Investigators

  • Principal Investigator: Sandra M Martinez, PHD student, University of A Coruña. Faculty of Physiotherapy, Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Castilla-La Mancha
ClinicalTrials.gov Identifier:
NCT04154527
Other Study ID Numbers:
  • 2014/610
First Posted:
Nov 6, 2019
Last Update Posted:
Mar 17, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Castilla-La Mancha
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2020