The first objective of the proposed research is to refine and test an instrument to evaluate the circumvaginal musculature (CVM) and to evaluate methods of conditioning the CVM. A second objective is to assess the effects of exercise on the dynamic characteristics of the CVM.
In Aim 1 (pilot study) 30 women (volunteers, ages 18-40, 15 non-parturient and 15 4-6 weeks postpartum) will be studied following the design and method outlined under Aim 2. The results of Aim 1 will be: (1) refinement of the instrumentation, and device production; (2) refinement and modification of the home training protocols; and (3) preliminary analysis of data.
In Aim 2, 150 women (75 non-parturient and 75 4-6 weeks postpartum) will be randomly assigned to three home training methods: (1) exercise with intravaginal devices for endurance and strength training, (2) exercise without devices for endurance and strength training, and (3) no exercise, devices in place and a reading substitute. Three types of intravaginal devices will be produced for subjects as follows: (1) balloon device with a plug and 1/8 inch connector (all subjects), (2) balloon device filled with sterile water to be used for endurance training (home training methods one and three), and (3) balloon device filled with high viscosity silicone for strength training (home training methods one and three). After an initial visit, the subjects will be assessed at baseline, at one month, and three months. The device will be connected to a strain gauge and strip chart recorder. During contractions of the CVM, the dynamic characteristics of the muscles will be assessed: specifically, (1) rate of pressure change, (2) maximum pressure sustained, (3) length of time pressure sustained, and (4) rate of return to baseline. The four variables will be analyzed separately. The analysis will take into consideration (1) training with three levels, (2) parturition with two levels, and (3) time i.e., data are collected at three points (three levels). ANOVA procedures to test the significance of the main effects for each of the three treatments and for interactions that may exist between them and, following these, """"""""post hoc"""""""" procedures which allow contrasting of levels within factors will be employed. The results will document the effect of exercise on the CVM in reproductive age women, and in women after childbirth. Instrumentation and procedures to further study the CVM will be available; the effect of exercise in aging women and with urinary stress incontinence is planned.
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