Sexual Dysfunction in Gynecologic Oncology Patients

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This project will evaluate sexual dysfunction in women who have had surgery for gynecologic cancer. The subjects will complete a set of questionnaires about health, daily living, sexual encounters, and pain before their surgery and three times following. Each subject will be randomized to receive either lidocaine or a placebo that is applied vaginally immediately prior to any sexual encounters for approximately 6 months while maintaining a journal of sexual encounters and pain. The subjects and healthcare providers will be blinded to the treatment randomization until intervention and data collection is complete. Total participation will last up to one year from the date of enrollment. Subjects will visit the clinic at the same time as regular cancer care visits, receive the blinded intervention and complete the surveys.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Bender
• Treatments: Lidocaine

Criteria

Inclusion criteria

• Female

• Age 18-99

• Planned to undergo primary surgical treatment at the University of Iowa Hospitals and Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, peritoneal, endometrial, or cervical cancer

• Able to give informed consent and follow study procedures

• No previous reactions to lidocaine applications

• Performance Status of 0 or 1

• Reports having engaged in vaginal intercourse at least once in the last 12 months

Exclusion criteria:

• Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or cervical cancer by pathology from primary biopsy or surgery (subjects will not be eligible to continue the trial beyond the initial completion of the questionnaires)

• Diagnosis of another malignancy within the past five years, excluding basal cell carcinoma of the skin

• Patients undergoing primary or adjuvant external pelvic radiation (excluding adjuvant vaginal brachytherapy)

• Previous reactions to lidocaine applications

• Previous reactions to lidocaine for the subjects' sexual partner(s)