- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04577872
The Effect of Pelvic Floor Exercise on Urinary Incontinence and Quality of Sex Life
November 9, 2020 updated by: Szeged University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supine group (n=22)
The 22 participants with lower muscle strength (under 60 microvolt) comprised the supine group.
|
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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
28 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edit Nagy, Habil. PhD, University of Szeged, Faculty of Health Sciences and Social Studies
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- Haslam J. The prevalence of stress urinary incontinence in women. Nurs Times. 2004 May 18;100(20):71-3. No abstract available.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
January 31, 2019
Study Registration Dates
First Submitted
September 23, 2020
First Submitted That Met QC Criteria
October 6, 2020
First Posted (Actual)
October 8, 2020
Study Record Updates
Last Update Posted (Actual)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Urination Disorders
- Neuromuscular Manifestations
- Elimination Disorders
- Urinary Incontinence
- Muscle Weakness
- Enuresis
Other Study ID Numbers
- 019234/2014/OTIG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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