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

NCT ID: NCT04577872

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Pelvic Floor Muscle Weakness Urinary Incontinence

Keywords

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pelvic floor muscle training transverse abdominal muscle ultrasound measurement urinary incontinence vaginal surface electromyography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supine group (n=22)

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

Group Type EXPERIMENTAL

Pelvic floor muscle training

Intervention Type OTHER

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.

Sitting group (n=19)

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

Group Type EXPERIMENTAL

Pelvic floor muscle training

Intervention Type OTHER

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.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edit Nagy, Habil. PhD

Role: PRINCIPAL_INVESTIGATOR

University of Szeged, Faculty of Health Sciences and Social Studies

References

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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.

Reference Type BACKGROUND
PMID: 17646112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25793212 (View on PubMed)

Haslam J. The prevalence of stress urinary incontinence in women. Nurs Times. 2004 May 18;100(20):71-3. No abstract available.

Reference Type RESULT
PMID: 15176284 (View on PubMed)

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.

Reference Type RESULT
PMID: 18877152 (View on PubMed)

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.

Reference Type RESULT
PMID: 30288727 (View on PubMed)

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.

Reference Type RESULT
PMID: 20833070 (View on PubMed)

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.

Reference Type RESULT
PMID: 16942457 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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http://www.medrxiv.org/content/10.1101/2020.03.20.20039586v1

Related Info

Other Identifiers

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019234/2014/OTIG

Identifier Type: -

Identifier Source: org_study_id