Clitoral Location in Relation to Sexual Function Using Pelvic Imaging

Completed

Conditions: Anorgasmia
Female Sexual Dysfunction

Registration Number: NCT01195701

Lead Sponsor: TriHealth Inc.

Brief Summary: Women who are unable to achieve orgasm compared to women who have normal orgasmic function may have different clitoral anatomy and different hormone levels. The investigators hypothesis is that women who have difficulty with orgasm may have a clitoris that is closer to the vagina and may have higher testosterone levels. Pelvic MRI will be used to observe whether clitoral measurements differ between women with normal orgasmic function vs. those with anorgasmia.

Detailed Description: Women unable with anorgasmia and those with normal orgasmic function will undergo pelvic MRI so that clitoral measurements can be taken and then compared for differences.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 35

Inclusion Criteria

Premenopausal female aged 18-55 years
Sexually active (at least 1 heterosexual partner in the past 4 weeks)
Cases must have difficulty with orgasm or be anorgasmic
Controls must have normal sexual function

Exclusion Criteria

Not sexually active
Homosexual orientation
Postmenopausal
Stage >2 pelvic organ prolapse (POP-Q measurements beyond hymen)
Urinary incontinence with coitus limiting sexual activity
Severe vaginal atrophy
Pelvic pain/dyspareunia (
Currently pregnant
Depression being treated with SSRIs (depression alone or treatment of depression with non-SSRI medications is not an exclusion)
Currently taking testosterone supplements
History of sexual abuse
Large pelvic mass (benign or cancerous) impeding MRI measurements or grossly abnormal pelvic anatomy.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clitoral Measurements Using Pelvic MRI	Between day 1-14 (follicular phase) of menstrual cycle	All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.

Secondary Outcome Measures

Name	Time	Method
Total Testosterone	Between day 1-14 (follicular phase) of menstrual cycle	Free \& total testosterone, and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements
Free Testosterone	Between day 1-14 (follicular phase) of menstrual cycle	Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements
Free Androgen Index	Between day 1-14 (follicular phase) of menstrual cycle	Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)
FSFI Arousal	baseline visit	The arousal domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual arousal; and confidence in becoming aroused (very low to very high confidence) and frequency of satisfaction with arousal (almost never to almost always). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the arousal score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.
FSFI Desire	baseline visit	The desire domain of the Female Sexual Function Index (FSFI) consists of two questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual desire. Item scores range from 1 to 5, with higher scores indicating better sexual function, and the domain score is weighted by a factor of 0.6, such that the domain score can range from 1.2 to 6.0.
Female Sexual Function Index (FSFI) Total Score	baseline visit	The FSFI is a validated index of sexual function, consisting of a total score and six subscales or domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total is the sum of the six domain scores, each of which is weighted as noted. The FSFI total score can range from 2 to 36, with higher scores indicating better sexual function. A total score of 26.55 has been identified as the ideal cut point for differentiating between normal sexual function and sexual dysfunction.
FSFI Orgasm	baseline visit	The orgasm domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of orgasm (almost never to almost always), difficulty in achieving orgasm (extremely difficult to not difficult), and satisfaction with the ability to reach orgasm (very dissatisfied to very satisfied). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the orgasm score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.
FSFI Lubrication	baseline visit	The lubrication domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency of lubrication (almost never to almost always), the difficulty in becoming lubricated (extremely difficult to not difficult), frequency of maintaining lubrication (almost never to almost always), and difficulty in maintaining lubrication (extremely difficult to not difficult). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the lubrication score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.
FSFI Satisfaction	baseline visit	The satisfaction domain of the Female Sexual Function Index (FSFI) consists of three questions and measures satisfaction (very dissatisfied to very satisfied) with emotional closeness with partner, sexual relationship with partner, and overall sexual relationship with partner. Item scores range from 0 (or 1) to 5, with higher scores indicating better sexual function, and the satisfaction score is weighted by a factor of 0.4, such that the domain score can range from 0.8 to 6.0.
FSFI Pain	baseline visit	The pain domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of discomfort or pain during and following vaginal penetration (almost never to almost always), and the level of discomfort or pain (very low to very high). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the pain score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.