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Vaginal Vault Testing

Population-based screening for vaginal cancer is not recommended as part of the Ontario Cervical Screening Program (OCSP) because vaginal cancer is rare. In addition, the effectiveness of treating the precursor of vaginal cancer (i.e., high-grade vaginal intraepithelial neoplasia [VaIN3]) has not been established. However, people who have had a hysterectomy with their cervix removed are still at risk for human papillomavirus (HPV)-related cancers, including vaginal cancer. Therefore, the OCSP has developed guidance on vaginal vault testing. People who have had a hysterectomy and retained their cervix should continue to be screened according to the OCSP’s cervical screening recommendations.

The guidance is intended for providers who may perform vaginal vault testing, including primary care providers and colposcopists as well as gynecologists who perform hysterectomies.

A summary of the guidance is presented below. For more information, please see the Ontario Cervical Screening Program Guidance for Vaginal Vault Testing.

Scope of guidance

In scope for this guidance are people who have had a total hysterectomy (i.e., uterus and cervix removed) for benign indications, as well as people with a history of cervical dysplasia and early cervical cancer (i.e., microinvasive cervical cancer, stage 1A1 only) treated with hysterectomy, with or without cone biopsy. Although these groups of people can be considered for vaginal vault testing, they are not necessarily appropriate to test. For guidance on who is appropriate to test, refer to the “Who to Consider Testing” section.

Populations that are out of scope for this guidance include people with a history of cervical cancer beyond stage 1A1; people who have been treated with radical trachelectomy, radiation or chemotherapy; and people who are under surveillance in the cancer system. Guidance for managing people in colposcopy is also out of scope at this time.

Who to consider testing

Based on Ontario data and limited published evidence, the post-hysterectomy population has been divided into two groups: elevated-risk and low-risk for VaIN3 and vaginal cancer.

The OCSP advises that vaginal vault testing may be appropriate for the elevated-risk group. This group consists of two categories of people, including women, transmasculine people and nonbinary people:

  • People with evidence of any of the following histologies in their cervix at hysterectomy (i.e., in the hysterectomy specimen), regardless of margin status or known HPV status:
    • low-grade squamous intraepithelial lesion (LSIL)
    • high-grade squamous intraepithelial lesion (HSIL)
    • adenocarcinoma in situ (AIS)
  • People with a history of early cervical cancer (microinvasive cervical cancer, stage 1A1 only), regardless of whether they still have evidence of cancer or pre-cancer at hysterectomy (i.e., cancer or pre-cancer may have been excised with a loop electrosurgical excision procedure [LEEP] or cone before hysterectomy)

Vaginal vault testing should only be performed on people in the elevated-risk group who are asymptomatic. Anyone with symptoms or signs of vaginal cancer (e.g., bleeding or lesions) should be immediately referred for appropriate evaluation and investigation.

The OCSP advises that vaginal vault testing is not appropriate for the low-risk group. This group consists of anyone who does not meet the criteria for the elevated-risk group, including:

  • People with a history of LSIL, HSIL or AIS histology in the cervix, but no evidence of it in the hysterectomy specimen
  • People with an unknown or no screening history, including Two-Spirit, transmasculine and nonbinary people who did not get cervical screening before their hysterectomy
  • People who have had an HPV-positive result in their screening history, but do not meet the elevated-risk criteria

Which test to use and when to test

HPV testing (with reflex cytology for people with HPV-positive test results) should be used to test the vaginal vault in the elevated-risk group. Do the test approximately six to 12 months after hysterectomy (or at the first post-operative visit, if preferred). To order the test, use the OCSP cervical screening requisition and choose the vaginal vault testing indication.

Managing HPV test results

Vaginal vault testing can be stopped after one negative HPV test result. Anyone with an HPV-positive test result should be referred to colposcopy, regardless of HPV type or reflex cytology test result. Anyone with an invalid HPV test result should repeat the test. If the repeat HPV test result is invalid, refer to colposcopy.

Interim guidance for people who had vaginal vault cytology testing post-hysterectomy before the launch of HPV testing in the OCSP

This interim guidance for vaginal vault testing is for people who already had one or more vaginal vault cytology tests before the formal guidance for vaginal vault testing was released with the implementation of HPV testing in the OCSP.

People who had one or more vaginal vault cytology tests with normal results do not need more testing. If someone’s most recent cytology result was abnormal, they should be managed according to that cytology test result (see Table 1).

Table 1: Guidance for vaginal vault HPV testing for people who had vaginal vault cytology testing post-hysterectomy
Most recent cytology-based vaginal vault test result (before HPV testing implementation) Recommended next step (after HPV testing is implemented)
Normal No further vaginal vault testing needed
Unsatisfactory Do an HPV test if criteria for vaginal vault testing are met, including LSIL, HSIL or AIS histology in the cervix at hysterectomy or a history of early cervical cancer (microinvasive cervical cancer stage 1A1 only), regardless of whether there is still evidence of cancer or pre-cancer at hysterectomy

If criteria for vaginal vault testing are not met, no further vaginal vault testing is needed
Low-grade (ASCUS or LSIL) HPV test in 12 months
High-grade (ASC-H, LSIL-H, HSIL, AGCa or AIS) Refer to colposcopy
High-grade (SCC, ACC or ACC-E) Refer to colposcopy or consider referral to gynecologic oncology centre if an obvious lesion is seen

ACC = adenocarcinoma; ACC-E = endocervical adenocarcinoma; AGC = atypical glandular cells; AIS = adenocarcinoma in situ; ASC-H = atypical squamous cells, cannot exclude HSIL; ASCUS = atypical squamous cells of undetermined significance; HSIL = high-grade squamous intraepithelial lesion; LSIL = low-grade squamous intraepithelial lesion; SCC = squamous cell carcinoma

aIncludes AGC-N-NOS, AEC-N-NOS (AGC-N = atypical glandular cells – favour neoplastic; AGC-NOS = AGC– not otherwise specified; AEC-N = atypical endocervical cells – favour neoplastic; AEC-NOS = AEC– not otherwise specified)