The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training
Vaginal Tampon Training
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, quality of life, pelvic floor muscle training, pelvic floor muscle exercises, vaginal tampon training
Eligibility Criteria
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).
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
intervention
Arm Description
pelvic floor muscle training
vaginal tampon training.
Outcomes
Primary Outcome Measures
Global rating of improvement
A four-point scale (worse, unchanged, improved, cured) was used to determine the subjective perception of SUI improvement
Secondary Outcome Measures
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.
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.
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.
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
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
Full Information
NCT ID
NCT02924740
First Posted
September 29, 2016
Last Updated
March 10, 2021
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT02924740
Brief Title
The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
Official Title
The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, quality of life, pelvic floor muscle training, pelvic floor muscle exercises, vaginal tampon training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
pelvic floor muscle training
Arm Title
intervention
Arm Type
Experimental
Arm Description
vaginal tampon training.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Floor Muscle Training
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Vaginal Tampon Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Global rating of improvement
Description
A four-point scale (worse, unchanged, improved, cured) was used to determine the subjective perception of SUI improvement
Time Frame
change from baseline subjective improvement at 12 weeks
Secondary Outcome Measure Information:
Title
Pelvic floor muscle strength (PFMS)
Description
A vaginal perineometer (Cardio Design Pty Ltd., Australia) will be used to assess PFME with an arbitrary scale of 0-12.
Time Frame
change from baseline pelvic floor muscle strength at 12 weeks
Title
Pelvic floor muscle endurance (PFME)
Description
A vaginal perineometer (Cardio Design Pty Ltd., Australia) will be used to assess PFME with an arbitrary scale of 0-12.
Time Frame
change from baseline pelvic floor muscle endurance at 12 weeks
Title
Severity of urinary incontinence
Description
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.
Time Frame
change from baseline severity of incontinence at 12 weeks
Title
Frequency of micturition
Description
Participants will complete three 24-h frequency volume charts on 3 nonconsecutive days, and the mean of the 3 days are obtained for analysis
Time Frame
change from baseline subjective improvement at 12 weeks
Title
Incontinent episodes
Description
Participants will complete three 24-h frequency volume charts on 3 nonconsecutive days, and the mean of the 3 days are obtained for analysis
Time Frame
change from baseline incontinent episodes at 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Türkan Akbayrak, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
9000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21741151
Citation
Kashanian M, Ali SS, Nazemi M, Bahasadri S. Evaluation of the effect of pelvic floor muscle training (PFMT or Kegel exercise) and assisted pelvic floor muscle training (APFMT) by a resistance device (Kegelmaster device) on the urinary incontinence in women: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):218-23. doi: 10.1016/j.ejogrb.2011.06.037. Epub 2011 Jul 7.
Results Reference
background
PubMed Identifier
1872333
Citation
Bump RC, Hurt WG, Fantl JA, Wyman JF. Assessment of Kegel pelvic muscle exercise performance after brief verbal instruction. Am J Obstet Gynecol. 1991 Aug;165(2):322-7; discussion 327-9. doi: 10.1016/0002-9378(91)90085-6.
Results Reference
background
PubMed Identifier
11279716
Citation
Hay-Smith EJ, Bo Berghmans LC, Hendriks HJ, de Bie RA, van Waalwijk van Doorn ES. Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2001;(1):CD001407. doi: 10.1002/14651858.CD001407.
Results Reference
background
PubMed Identifier
29536140
Citation
Orhan C, Akbayrak T, Ozgul S, Baran E, Uzelpasaci E, Nakip G, Ozgul N, Beksac MS. Effects of vaginal tampon training added to pelvic floor muscle training in women with stress urinary incontinence: randomized controlled trial. Int Urogynecol J. 2019 Feb;30(2):219-229. doi: 10.1007/s00192-018-3585-7. Epub 2018 Mar 13.
Results Reference
derived
Learn more about this trial
The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
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