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

Study Overview
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Brief Summary
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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.

Detailed Description
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Urinary incontinence (UI) is defined by the International Urogynecological Association and the International Continence Society (IUGA/ICS) as a complaint of involuntary loss of urine which is objectively shown and causing hygienic and social problems. Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion, or on sneezing or coughing. 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. It was found that the effect of exercises applying with a device was similar with PFMT in women with SUI and mixed type UI. Vaginal cones are weights that put into the vagina. The theory of the use of vaginal cones is that when the feeling of slipping is perceived, reflex or voluntary contraction of pelvic floor muscles occur to avoid this slipping. It was reported that the use of cones should be questioned in terms of exercise physiology. Holding the cone for 15-20 minutes may result in decreased blood supply, decreased oxygen consumption, muscle fatigue and pain, and contraction of other muscle. On the other hand, 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 cone. Vaginal tampons are also sterile, hygienic, and single use. There is also 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. Vaginal tampon training will be applied for 5 days a week for 12 weeks. Vaginal tampon exercises 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). Both groups will complete PFMT consisting 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). Patients were advised to exercise while in the supine, seated, and upright positions and to integrate these exercises into their daily activities, e.g., while watching television, waiting for something, traveling.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Behavioral: Pelvic Floor Muscle Training
* Behavioral: Vaginal Tampon Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: having symptoms of SUI according to MESA urinary incontinence questionnaire; age>18 and < 65 years; having the ability of pelvic floor muscle contraction, being free of UI medications for at least 4 weeks before the start of the study; and sufficient literacy to complete required forms and urinary diaries and perform training protocols. Exclusion Criteria: antenatal or postnatal women (up to 3 months after delivery), women with persistent urinary tract infections, impaired mental state, Stage 3 and 4 pelvic organ prolapse (POP), neurological disorders, and who received concurrent or recent physiotherapy intervention (within the last year).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>pelvic floor muscle training | Behavioral: Pelvic Floor Muscle Training<br>* 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).<br>|
| Experimental: intervention<br>vaginal tampon training. | Behavioral: Pelvic Floor Muscle Training<br>* 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).<br>Behavioral: Vaginal Tampon Training<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global rating of improvement | A four-point scale (worse, unchanged, improved, cured) was used to determine the subjective perception of SUI improvement | change from baseline subjective improvement at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle strength (PFMS) | A vaginal perineometer (Cardio Design Pty Ltd., Australia) will be used to assess PFME with an arbitrary scale of 0-12. | change from baseline pelvic floor muscle strength at 12 weeks | 
| Pelvic floor muscle endurance (PFME) | A vaginal perineometer (Cardio Design Pty Ltd., Australia) will be used to assess PFME with an arbitrary scale of 0-12. | change from baseline pelvic floor muscle endurance at 12 weeks | 
| Severity of urinary incontinence | The severity of urinary incontinence will be questioned using the Incontinence Severity Index (ISI). The ISI included two items such as the frequency of urinary incontinence and amount of urinary incontinence. The total score is calculated by multiplying these items. The total score of ISI rages from 0 to 12. Higher scores presents severe urinary incontinence. | change from baseline severity of incontinence at 12 weeks | 
| Frequency of micturition | Participants will complete three 24-h frequency volume charts on 3 nonconsecutive days, and the mean of the 3 days are obtained for analysis | change from baseline subjective improvement at 12 weeks | 
| Incontinent episodes | Participants will complete three 24-h frequency volume charts on 3 nonconsecutive days, and the mean of the 3 days are obtained for analysis | change from baseline incontinent episodes at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, quality of life, pelvic floor muscle training, pelvic floor muscle exercises, vaginal tampon training