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Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Sexual Dysfunction, Physiological

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Trial Information

Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial


Inclusion Criteria:



- Age ≥18

- History of a gynecologic cancer

- No evidence of disease at time of inclusion in the study

- Postmenopausal (either surgical or natural menopause)

- Self report of sexual dysfunction that did not predate cancer diagnosis

- Suspected physical component to sexual dysfunction with the participant, not sexual
partner

- Desire to improve sexual function

- ECOG Performance status score of 2 or better

- Six months or greater from last surgical and/or radiation treatment

Exclusion Criteria:

- History of sexual reassignment

- Presence of vaginal fistula

- Does not desire to improve sexual function

- Already using the vaginal renewal program

- Not fluent in English

- Incarceration

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

FSFI score

Outcome Description:

FSFI is the Female Sexual Function Index, which is a 19-item sexual functioning questionnaire.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

David M Kushner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2011-0217

NCT ID:

NCT01444911

Start Date:

August 2011

Completion Date:

September 2013

Related Keywords:

  • Sexual Dysfunction, Physiological
  • Sexual Dysfunction
  • Gynecologic cancer
  • Cancer survivor
  • Vaginal dilator
  • Sexual Dysfunctions, Psychological
  • Sexual Dysfunction, Physiological

Name

Location
University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States Madison, Wisconsin  53792