CClinicalTrials.gg
CompletedNCT04577872Updated Nov 12, 2020

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

An interventional study of Pelvic floor muscle training in Pelvic Floor Muscle Weakness and Urinary Incontinence, sponsored by Szeged University. Completed. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-12.

Sponsored by Szeged University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 8 months after the study started (first participant enrolled Jan 2016, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years to 25 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pelvic Floor Muscle Weakness
  • Urinary Incontinence

Keywords

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

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 55 is above the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
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).

Exclusion criteria

Exclusion Criteria:

  • known neurological or rheumatological diseases and previous vaginal or abdominal surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Supine group (n=22)

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

    Other: Pelvic floor muscle training

  • 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)

Interventions

  • OtherPelvic 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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 28 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17646112 ↗
  • 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. PubMed 25793212 ↗
  • Haslam J. The prevalence of stress urinary incontinence in women. Nurs Times. 2004 May 18;100(20):71-3. No abstract available. PubMed 15176284 ↗
  • 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. PubMed 18877152 ↗
  • 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. PubMed 30288727 ↗
  • 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. PubMed 20833070 ↗
  • 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. PubMed 16942457 ↗

Related links

Study documents

  • Protocol, analysis plan and consent form · Apr 7, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04577872
Lead sponsor
Szeged University
Responsible party
Sponsor
First posted
Oct 8, 2020
Start date
Jan 1, 2016
Primary completion
Apr 30, 2018
Completion
Jan 31, 2019
Last update
Nov 12, 2020

Study contacts

Edit Nagy, Habil. PhD
principal investigator · University of Szeged, Faculty of Health Sciences and Social Studies

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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