Validity and Reliability of an Instrumented Speculum Designed to Minimize the Effect of Intra-abdominal Pressure on the Measurement of Pelvic Floor Muscle Strength

Background: Measurements of pelvic floor muscle strength are contaminated by crosstalk from intra-abdominal pressure. We tested an improved instrumented speculum designed to minimize this crosstalk. The hypotheses were that the speculum yields: 1) maximum vaginal closure forces unrelated to intra-abdominal pressure, 2) discriminatory validity between women with strong vs. weak pelvic floor muscles, and 3) acceptable test-retest reliability.

Methods: Maximum voluntary vaginal closure force was measured in 40 incontinent women (20-77 years) on two visits spaced one month apart. At the baseline visit, intra-abdominal pressure was also estimated via intra-vesical catheterization during the vaginal closure force measurement. Subjective estimate of pelvic floor muscle strength was also assessed using digital palpation by a skilled examiner to determine group placement as "strong" (n=31) or "weak" (n=9).

Findings: Vaginal closure force was not significantly correlated with intra-abdominal pressure (r=-.26, P=.109). The groups with subjectively scored strong and weak pelvic floor muscles differed significantly by mean [SD] maximum vaginal closure force (3.8 [1.7] vs. 1.9 [0.8] N respectively, P<.01.) Across both time points the mean vaginal closure force was 3.42 [1.67] N with a range of .68 to 9.05 N. Mean Visit 1 and Visit 2 vaginal closure force scores did not differ (3.41 [1.8] and 3.42 [1.6] N, respectively). The vaginal closure force repeatability coefficient was 3.1N.

Interpretation: The improved speculum measured maximum vaginal closure force without evidence of crosstalk from intra-abdominal pressure, while retaining acceptable discriminant validity and repeatability.