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Stress Urinary IncontinenceNCT02924740

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

A study testing Pelvic Floor Muscle Training and Vaginal Tampon Training in people with Stress Urinary Incontinence, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Stress Urinary Incontinence
What is being tested?
Pelvic Floor Muscle Training and Vaginal Tampon Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2016to Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara, 9000

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
Pelvic Floor Muscle Training, Vaginal Tampon Training
Keywords
stress urinary incontinence, quality of life, pelvic floor muscle training, pelvic floor muscle exercises, vaginal tampon training
Medical subject headings
Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic Floor Muscle TrainingBehavioural

    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 TrainingBehavioural

    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).

Study groups in NCT02924740
Study groupRoleWhat they receive
controlActive comparatorpelvic floor muscle training
Receives: Behavioral: Pelvic Floor Muscle Training
interventionExperimentalvaginal tampon training.
Receives: Behavioral: Pelvic Floor Muscle Training; Behavioral: Vaginal Tampon Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global rating of improvement

    A four-point scale (worse, unchanged, improved, cured) was used to determine the subjective perception of SUI improvement

    Measured: change from baseline subjective improvement at 12 weeks

Secondary outcomes (5)
  1. 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.

    Measured: change from baseline pelvic floor muscle strength at 12 weeks

  2. 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.

    Measured: change from baseline pelvic floor muscle endurance at 12 weeks

  3. 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.

    Measured: change from baseline severity of incontinence at 12 weeks

  4. 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

    Measured: change from baseline subjective improvement at 12 weeks

  5. 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

    Measured: change from baseline incontinent episodes at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02924740
Sponsor's protocol ID
GO 16/506-18
Status last verified
Mar 2021
First submitted
29 Sep 2016
Last updated
12 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 21741151
  • 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.

    PubMed 1872333
  • 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.

    PubMed 11279716
  • Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

    PubMed 39704322
  • 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.

    PubMed 29536140

Questions about this trial

What is this clinical trial studying?

A study testing Pelvic Floor Muscle Training and Vaginal Tampon Training in people with Stress Urinary Incontinence, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global rating of improvement (time frame: change from baseline subjective improvement at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02924740, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.

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