CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Pelvic Floor Muscle Training +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT02924740
NCT02924740N/ACompleted

The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence

Hacettepe University·interventional·Posted Oct 5, 2016·Updated Mar 12, 2021

In Brief

A clinical study evaluating Pelvic Floor Muscle Training and Vaginal Tampon Training for Stress Urinary Incontinence. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Pelvic Floor Muscle Training (PFMT) is the basis of conservative treatment in women with SUI. In systematic reviews, PFMT was recommended as a first option for treatment of SUI. The aim of PFMT is to improve sphincter activity and increase the support of bladder and urethra. Recommendations regarding the prevention and treatment of SUI with PFMT include Knack maneuver (the conscious contraction of the pelvic floor before and during the abdominal pressure increases); pelvic floor exercises to enhance the structural support and endurance of pelvic floor muscles; adding transversus abdominis contraction; and functional rehabilitation.It was reported that the progressive overload principle should be considered to improve the muscle strength and endurance. According to this principal, resistance against to movement, duration and/or frequency should be increased to obtain the optimal response. There are a lot of methods to run a muscle or muscle group based on the progressive overload principal. These are adding resistance or weight, increasing the duration and number of contraction, changing the type of exercise and the range of movement. In the literature, it was reported that special vaginal or rectal tools, vaginal cones or tampons might be used to establish resistance during the pelvic floor muscle exercises.the use of cones in a different way may provide extra benefit for patients: patients can be instructed to perform pelvic floor muscle contraction and try to pull the cone or the other tools out of the vagina. In this study, investigators preferred to use vaginal tampons since pulling the cone out of the vagina cause the elimination of the weight of the cone. Vaginal tampons are also sterile, hygienic, and single use. There is no study investigates the effects of vaginal tampon exercises in the literature. Therefore, the aim of this study is to investigate the effect of the vaginal tampon training adding to PFMT on symptoms of the urinary incontinence, the strength and the endurance of pelvic floor muscles and the quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 5, 2016
Enrollment StartOct 1, 2016
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.7 years ago

Interventions

Pelvic Floor Muscle Trainingbehavioral

Pelvic floor muscle training consist of fast (2 second) and slow contractions (5-s contraction, 10-s hold, 5-s relaxation, totally 20-s). One set of exercises includes ten fast and ten slow voluntary PFM contractions (VPFMCs). During week 1 and 2, participants will be instructed to perform two sets of exercises per day (20 fast and 20 slow contractions per day), which was progressively increased by two sets: four sets per day at week 3 and 4 (40 fast and 40 slow contractions per day); six sets per day at week 5 and 6 (60 fast and 60 slow contractions per day); eight sets per day at week 7 and 8 (80 fast and 80 slow contractions per day); ten sets per day from week 9 to week 12 (100 fast and 100 slow contractions per day).

Vaginal Tampon Trainingbehavioral

Vaginal tampon training will be applied for 5 days a week for 12 weeks. Exercises with tampons will be performed two days a week by physiotherapist (first author) and three days a week by patients. One set of tampon exercises consist 15 contractions. During vaginal tampon training, from week 1 to week 12, patients were instructed to perform two sets of exercises for five days a week (two days by physiotherapist, three days by themselves).