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

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.

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

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

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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