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

Primary Purpose

Pelvic Floor Muscle Weakness, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic floor muscle training
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Muscle Weakness focused on measuring pelvic floor muscle training, transverse abdominal muscle, ultrasound measurement, urinary incontinence, vaginal surface electromyography

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Supine group (n=22)

    Sitting group (n=19)

    Control group (n=14)

    Arm Description

    The 22 participants with lower muscle strength (under 60 microvolt) comprised the supine group.

    The 19 participants with higher muscle strength (over 60 microvolt) formed the sitting group.

    The control group comprised 7 individuals with lower muscle strength (under 60 microvolt) and 7 with higher muscle strength (over 60 microvolt)

    Outcomes

    Primary Outcome Measures

    Investigation of the effects of the pelvic floor muscle training (PFM-T)
    It is measured the change of the pelvic floor muscle with Vaginal surface electromyography (vsEMG).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2020
    Last Updated
    November 9, 2020
    Sponsor
    Szeged University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04577872
    Brief Title
    The Effect of Pelvic Floor Exercise on Urinary Incontinence and Quality of Sex Life
    Official Title
    The Effect of Pelvic Floor Exercise on Urinary Incontinence and Quality of Sex Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    April 30, 2018 (Actual)
    Study Completion Date
    January 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Szeged University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Floor Muscle Weakness, Urinary Incontinence
    Keywords
    pelvic floor muscle training, transverse abdominal muscle, ultrasound measurement, urinary incontinence, vaginal surface electromyography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supine group (n=22)
    Arm Type
    Experimental
    Arm Description
    The 22 participants with lower muscle strength (under 60 microvolt) comprised the supine group.
    Arm Title
    Sitting group (n=19)
    Arm Type
    Experimental
    Arm Description
    The 19 participants with higher muscle strength (over 60 microvolt) formed the sitting group.
    Arm Title
    Control group (n=14)
    Arm Type
    No Intervention
    Arm Description
    The control group comprised 7 individuals with lower muscle strength (under 60 microvolt) and 7 with higher muscle strength (over 60 microvolt)
    Intervention Type
    Other
    Intervention Name(s)
    Pelvic floor muscle training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Investigation of the effects of the pelvic floor muscle training (PFM-T)
    Description
    It is measured the change of the pelvic floor muscle with Vaginal surface electromyography (vsEMG).
    Time Frame
    28 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    nulliparous women
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edit Nagy, Habil. PhD
    Organizational Affiliation
    University of Szeged, Faculty of Health Sciences and Social Studies
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17646112
    Citation
    Madill SJ, McLean L. Quantification of abdominal and pelvic floor muscle synergies in response to voluntary pelvic floor muscle contractions. J Electromyogr Kinesiol. 2008 Dec;18(6):955-64. doi: 10.1016/j.jelekin.2007.05.001. Epub 2007 Jul 23.
    Results Reference
    background
    PubMed Identifier
    25793212
    Citation
    Chmielewska D, Stania M, Sobota G, Kwasna K, Blaszczak E, Taradaj J, Juras G. Impact of different body positions on bioelectrical activity of the pelvic floor muscles in nulliparous continent women. Biomed Res Int. 2015;2015:905897. doi: 10.1155/2015/905897. Epub 2015 Feb 22.
    Results Reference
    background
    PubMed Identifier
    15176284
    Citation
    Haslam J. The prevalence of stress urinary incontinence in women. Nurs Times. 2004 May 18;100(20):71-3. No abstract available.
    Results Reference
    result
    PubMed Identifier
    18877152
    Citation
    KEGEL AH. Progressive resistance exercise in the functional restoration of the perineal muscles. Am J Obstet Gynecol. 1948 Aug;56(2):238-48. doi: 10.1016/0002-9378(48)90266-x. No abstract available.
    Results Reference
    result
    PubMed Identifier
    30288727
    Citation
    Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.
    Results Reference
    result
    PubMed Identifier
    20833070
    Citation
    Capson AC, Nashed J, Mclean L. The role of lumbopelvic posture in pelvic floor muscle activation in continent women. J Electromyogr Kinesiol. 2011 Feb;21(1):166-77. doi: 10.1016/j.jelekin.2010.07.017. Epub 2010 Sep 15.
    Results Reference
    result
    PubMed Identifier
    16942457
    Citation
    Sapsford RR, Richardson CA, Stanton WR. Sitting posture affects pelvic floor muscle activity in parous women: an observational study. Aust J Physiother. 2006;52(3):219-22. doi: 10.1016/s0004-9514(06)70031-9.
    Results Reference
    result
    Links:
    URL
    http://www.medrxiv.org/content/10.1101/2020.03.20.20039586v1
    Description
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