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The Effect of Pelvic Floor Exercise on Urinary Incontinence and Quality of Sex Life

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ClinicalTrials.gov Identifier: NCT04577872
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Szeged University

Brief Summary:
This physiotherapist-guided group training programme should be performed in both the supine and the sitting positions; it is investigated, which is better and more cost-effective in patient motivation.

Condition or disease Intervention/treatment Phase
Pelvic Floor Muscle Weakness Urinary Incontinence Other: Pelvic floor muscle training Not Applicable

Detailed Description:
Here we aimed to investigate whether-based on trunk muscle synergism-the condition and functioning of the pelvic floor muscle would improve in the sitting and supine postures or in the control group during pelvic floor muscle training with forced exhalation. We enrolled nulliparous women in supine (n = 22), sitting (n = 19) and control (n = 14) groups. We performed the 8-week combined pelvic floor muscle training programme. We examined the effect of training on the parameters with the Kruskal-Wallis test, and the pairwise comparisons with the Mann-Whitney U-test and the Wilcoxon-rank test with the Bonferroni correction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Pelvic Floor Exercise on Urinary Incontinence and Quality of Sex Life
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supine group (n=22)
The 22 participants with lower muscle strength (under 60 microvolt) comprised the supine group.
Other: Pelvic floor muscle training
The treatment for the sitting group comprised 8 sessions, with a 1-hour combined pelvic floor muscle training (cPFM-T) session each week in a group and 15 minutes of individual home training, six times a week for a total of 8 weeks of treatment. All training sessions comprised warming-up, gradual muscle strengthening and relaxation exercises. In the study, before and after the training programme, we used a self-administered questionnaire.We measured changes in pelvic floor muscle activity with a vaginal surface electromyographic instrument. We performed the transversus abdominis measurements at the same time as the vaginal measurements and pelvic floor muscle tasks.

Experimental: Sitting group (n=19)
The 19 participants with higher muscle strength (over 60 microvolt) formed the sitting group.
Other: Pelvic floor muscle training
The treatment for the sitting group comprised 8 sessions, with a 1-hour combined pelvic floor muscle training (cPFM-T) session each week in a group and 15 minutes of individual home training, six times a week for a total of 8 weeks of treatment. All training sessions comprised warming-up, gradual muscle strengthening and relaxation exercises. In the study, before and after the training programme, we used a self-administered questionnaire.We measured changes in pelvic floor muscle activity with a vaginal surface electromyographic instrument. We performed the transversus abdominis measurements at the same time as the vaginal measurements and pelvic floor muscle tasks.

No Intervention: Control group (n=14)
The control group comprised 7 individuals with lower muscle strength (under 60 microvolt) and 7 with higher muscle strength (over 60 microvolt)



Primary Outcome Measures :
  1. Investigation of the effects of the pelvic floor muscle training (PFM-T) [ Time Frame: 28 months ]
    It is measured the change of the pelvic floor muscle with Vaginal surface electromyography (vsEMG).



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   nulliparous women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • We included in the study groups women participants willing to participate in the study and able to contract the pelvic floor and transversus abdominis muscles correctly. Participants were required to maintain their everyday activities (attending lessons, sport activities, and so on).

Exclusion Criteria:

  • known neurological or rheumatological diseases and previous vaginal or abdominal surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577872


Sponsors and Collaborators
Szeged University
Investigators
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Principal Investigator: Edit Nagy, Habil. PhD University of Szeged, Faculty of Health Sciences and Social Studies
  Study Documents (Full-Text)

Documents provided by Szeged University:
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Szeged University
ClinicalTrials.gov Identifier: NCT04577872    
Other Study ID Numbers: 019234/2014/OTIG
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Szeged University:
pelvic floor muscle training
transverse abdominal muscle
ultrasound measurement
urinary incontinence
vaginal surface electromyography
Additional relevant MeSH terms:
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Muscle Weakness
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes