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Purpose

Simple hysterectomy and pelvic node assessment (SHAPE) is a phase III randomized trial (ClinicalTrials.gov identifier: ) reporting noninferiority of simple compared with radical hysterectomy for oncologic outcomes in low-risk cervical cancer. This study presents secondary outcomes of sexual health and quality of life (QOL) of the SHAPE trial.

Methods

Participants were randomly assigned to receive either radical or simple hysterectomy. Sexual health was assessed up to 36 months postoperatively using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised and QOL using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Cervical Cancer-Specific Module (QLQ-CX24) questionnaires.

Results

Among participants with at least one QOL measure, clinical and pathologic characteristics were balanced and with no differences in preoperative baseline scores for sexual health or QOL between groups. FSFI total score met the cutoff for dysfunction up to 6 months (P=0.02) in the radical hysterectomy group. Group differences favored simple hysterectomy for FSFI subscales: desire and arousal at 3 months (P≤0.001) and pain and lubrication up to 12 months (P≤0.018). Both groups met the cutoff for sexual distress but was higher in radical hysterectomy at 3 months (P=0.018). For QLQ-CX24, symptom experience was significantly better up to 24 months (P=0.031) and body image better at 3, 24, and 36 months (P≤0.01) for simple hysterectomy. Sexual-vaginal functioning was significantly better up to 24 months (P≤0.022) and more sexual activity up to 36 months (P=0.024) in the simple hysterectomy arm. Global health status was significantly higher at 36 months for simple hysterectomy (P=0.025).

Conclusion

Simple hysterectomy was associated with lower rates of sexual dysfunction than radical hysterectomy, with a lower proportion of women having sustained sexual-vaginal dysfunction. These results further support the benefit of surgical de-escalation for low-risk cervical cancer.

Read a Q&A about the study here.