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