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

Sponsor

Szeged University (Other)

Overall Status

Completed

CT.gov ID

NCT04577872

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Muscle Weakness Urinary Incontinence	Other: Pelvic floor muscle training	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2016

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

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)

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

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)

Outcome Measures

Primary Outcome Measures

Investigation of the effects of the pelvic floor muscle training (PFM-T) [28 months]
It is measured the change of the pelvic floor muscle with Vaginal surface electromyography (vsEMG).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).