Test-retest reliability of an instrumented speculum for measuring vaginal closure force

Abstract

Aims: The study aimed to: a) determine reliability of an instrumented speculum designed for measuring intravaginal closure pressure, and b) compare findings with a comparable device reported in the literature. The goal of these new devices is to reduce subjectivity, improve precision, and acknowledge reliability issues in quantifying levator ani closure force acting on the vagina.

Methods: The instrumented speculum consisted of two parallel aluminum bills, similar in size to a Peterson speculum. Strain gages located near the root of each bill measure the magnitude of force exerted in the distal vagina. A contraction of the "U-shaped" levator ani muscle closes the levator hiatus with resultant reaction force measured by the speculum in the mid-sagittal plane. We tested the device in twelve nulliparous women making repeated measures within and across 3 different visit days. All measures were made by the same investigator.

Results: Same day measures were repeatable within +/-3.8 N by the third visit, with lesser repeatability on the 1st and 2nd visit days. Across days, repeatability was improved by Visits 2 and 3 with a coefficient of repeatability between those days of +/-5.5 N. Better repeatability was obtained using averaged scores rather than 'best effort' ; but average scores can underestimate best effort.

Conclusion: Reasonable within-visit repeatability was found. Across-visit repeatability is consistent with the known difficulty that women have in maximally isolating and activating their levator ani muscles. The results corroborate the repeatability results of Dumoulin et al. [2004] using a similar type of dynamometer.

Fig. 1

Photograph showing the device and how it was held between the tips of the thumb and first two fingers for the measurements. The strain gages are covered with a white silicone sealant to protect them from moisture. The vertical line in the background illustrates the 5 cm depth to which the bills were inserted. [Color figure can be viewed in the online issue, which is available at www.interscience.wiley.com.]

Fig. 2

Plots of the differences between repeated intravaginal closure force measures obtained in newtons (N) during maximal voluntary contraction (MVC) maneuvers on Visit 1, Visit 2, and Visit 3. [Color figure can be viewed in the online issue, which is available at www.interscience.wiley.com.]