The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

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.
    

Intervention name(s): Pelvic Floor Muscle Training; Vaginal Tampon Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stress urinary incontinence; quality of life; pelvic floor muscle training; pelvic floor muscle exercises; vaginal tampon training