Status:
TERMINATED
Sexual Dysfunction in Gynecologic Oncology Patients
Lead Sponsor:
David Bender
Conditions:
Gynecologic Cancer
Sexual Dysfunction
Eligibility:
FEMALE
18-99 years
Phase:
PHASE4
Brief 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, an...
Detailed Description
Once consented, subjects will complete nine short surveys (The Female Sexual Function Index, The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index, the Severity of...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03801031
Start Date
June 6 2019
End Date
November 3 2021
Last Update
December 6 2022
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242