The development and validation of two diagnostic methods for an open vagina

Mortiers X1, Neels H2, De Graaf S1, De Wachter S G2, Tjalma W2, Vermandel A2

Research Type

Clinical

Abstract Category

Quality of Life / Patient and Caregiver Experiences

Abstract 603
Open Discussion ePosters
Scientific Open Discussion ePoster Session 28
Friday 31st August 2018
13:00 - 13:05 (ePoster Station 12)
Exhibition Hall
Pelvic Floor Pathophysiology Quality of Life (QoL) Questionnaire Terminology
1. University of Antwerp, 2. University of Antwerp; Antwerp University Hospital
Presenter
H

Hedwig Neels

Links

Poster

Abstract

Hypothesis / aims of study
An open vagina can be linked to vaginal flatulence. Vaginal flatulence is an embarrassing symptom that can have a high impact on the quality of life of the women who are coping with it. Although it is regularly discussed between women, on digital forums and in popular literature, a systematic review revealed that vaginal wind is an underestimated and understudied problem in the medical literature [1]. Nowadays, agreement and high-quality research on a conclusive definition, a standardised diagnostic method, prevalence and incidence data on open vaginas are lacking . A correct and standardised diagnosis would make further research possible as to determine prevalence, cause(s), QoL, and treatment options for an open vagina. Besides that, future research should be performed to further determine the connection between an open vagina and vaginal flatulence.
The aim of this study was to develop a reliable and valid method to diagnose an open vagina, consisting of a standardised photo  measuring analysis method (PHoto Analysis for Diagnosing Open Vagina (PHADOV)) and a questionnaire (QUestionnaire for Diagnosing Open Vagina and Vaginal Flatulence (QUDOVVF)).
Study design, materials and methods
This study was conducted in a population of premenopausal women aged 18-50 years. The researchers analysed reliability and validity of both methods separately, and compared both methods through analysing the degree of agreement. 
For PHADOV, every subject’s genital area was photographed in a standardised manner. Researcher one took six pictures: two in rest, two during contraction of the pelvic floor and two during Valsalva manoeuvre. This process (positioning of subject and camera, then taking photos) was repeated by researcher two. In every photo, horizontal and vertical diameter of the vaginal opening were measured and its surface area was calculated. The researchers analysed inter-rater and intra-rater reliability using Intraclass Correlation Coefficient (ICC) statistics. 
For QUDOVVF, every subject completed the questionnaire twice, with a three-day interval. Reliability of every question was analysed using ICC statistics. The questionnaire, created in accordance with the most common guidelines, contains questions about gynaecological history, the potentially open vagina, the presence of vaginal wind and the QoL, including relational, sexual and social aspects.
Validity of both PHADOV and QUDOVVF was assessed using expert opinion.
The degree of agreement of PHADOV and QUDOVVF was analysed by first determining if the vagina of the subject was closed or open according to both diagnostic methods separately. Afterwards, Cohen’s kappa statistics were used.
This study has been approved by a local ethical committee. It was conducted only after requiring the subjects’ informed consent.
Results
PHADOV:
Inter-rater reliability of PHADOV (ICC) ranges from 0.457 to 0.820 in rest; 0.376 to 0.824 during contraction of PFM; and 0.533 to 0.852 during Valsalva manoeuvre. Intra-rater reliability of PHADOV (ICC) ranges from 0.755 to 0.998 in rest; 0.920 to 1.000 during contraction of the PFM; and 0.875 to 1.000 during Valsalva manoeuvre. (see Table 1)

QUDOVVF: 
ICC’s were in the range of 0.81-1.00 for 20 questions, in the range of 0.61-0.80 for 14 questions, and ≤0.60 for 9 questions. 

No results are available yet on the validity of PHADOV nor QUDOVVF. 

The kappa value that was calculated to determine the degree of agreement of PHADOV and QUDOVVF is -0.189.
Interpretation of results
For PHADOV, it appears that the inter-rater reliability of the horizontal measurements is moderate (ICCs 0.41-0.60) to substantial (ICCs 0.61-0.80). However, the inter-rater reliability of the vertical and surface area measurements is better, with substantial to almost perfect (ICCs 0.81-1.00) results. The intra-rater reliability is good as well, with substantial to almost perfect results. 

For QUDOVVF, the reliability is almost perfect for twenty questions, substantial for fourteen questions and less than substantial for nine questions.

The degree of agreement of PHADOV and QUDOVVF is poor (k-0.189). This could mean that some women with an open vagina do not have symptoms or are not bothered by it.
Concluding message
The high inter-rater reliability of PHADOV and the overall reasonable to high reliability of QUDOVVF are high, but the degree of agreement of these methods appears low. This suggests the subjects’ subjective complaints cannot be correlated with the objective measurements. Women subjectively identify an open vagina less often than objective photo analysis does.
Besides that, PHADOV and QUDOVVF need adjustments, so that the reliability of horizontal measurements in PHADOV as well as the reliability of QUDOVVF can be further improved. Also, future research should be performed, using these tools to determine if an open vagina is a cause of vaginal flatulence.
Figure 1
Figure 2
References
  1. Neels H, Mortiers X, de Graaf S, Tjalma WAA, De Wachter S, Vermandel A. Vaginal wind: A literature review. European journal of obstetrics, gynecology, and reproductive biology. 2017;214:97-103.
Disclosures
<span class="text-strong">Funding</span> no funding <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Antwerp University Hospital <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes