Full text of DOI:10.1080/713846821

Journal of Sex & Marital Therapy
ISSN: 0092-623X (Print) 1521-0715 (Online) Journal homepage: http://www.tandfonline.com/loi/usmt20
The Use of the Female Intervention Efficacy
Index (FIEI) as an Immediate Outcome Measure
of Medical Intervention to Treat Female Sexual
Dysfunction
Laura A. Berman , Jennifer R. Berman , Tiffany Werbin , Sachin Chabra &
Irwin Goldstein
To cite this article: Laura A. Berman , Jennifer R. Berman , Tiffany Werbin , Sachin Chabra &
Irwin Goldstein (2001) The Use of the Female Intervention Efficacy Index (FIEI) as an Immediate
Outcome Measure of Medical Intervention to Treat Female Sexual Dysfunction, Journal of Sex
& Marital Therapy, 27:5, 427-433, DOI: 10.1080/713846821
To link to this article: http://dx.doi.org/10.1080/713846821
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Journal of Sex & Marital Therapy, 27:427–433, 2001
Copyright © 2001 Brunner-Routledge
0092-623X/01 $12.00 + .00
The Use of the Female Intervention Efficacy
Index (FIEI) as an Immediate Outcome
Measure of Medical Intervention to Treat
Female Sexual Dysfunction
LAURA A. BERMAN, JENNIFER R. BERMAN,
TIFFANY WERBIN, SACHIN CHABRA,
and IRWIN GOLDSTEIN
Division of Urology, UCLA Medical Center, Los Angeles, California, USA
Many medications used in the treatment of male erectile dysfunc-
tion are still in the experimental phases for use in women. Numer-
ous pharmacological options for women presently under testing
include the EROS-CTD clitoral therapy device (Berman et al., 1999b;
Billups et al., 2001). In addition to the new medical developments
for treating female sexual dysfunction, methods for evaluating
sexual responses and efficacy of intervention are evolving as well.
To evaluate the effectiveness of an intervention, quantifiable, subjective sexual
response data that reflect the personal experience of the patient are neces-
sary. Intervention is not considered successful unless the woman is able to
subjectively experience sexual arousal, pleasure, and satisfaction. Thus, it is
important to determine if physiological changes or improvement in blood
flow translate into an improved sexual experience.
One of the major difficulties in assessing the efficacy of treatments for
female sexual dysfunction (such as the use of sildenafil) is the lack of effec-
tive and immediate subjective measures for these treatments. Valid and reli-
able outcome measures in the area of sexuality are limited. The three most
widely used measurements include The Derogatis Sexual Functioning In-
ventory (DSFI), the Brief Index of Sexual Functioning for Women (BISF-W),
and the Index of Female Sexual Function (IFSF). These valuable clinical
tools primarily provide global measurement of sexual function, evaluation of
longer-term improvements. While such global measurement is useful for
Address correspondence to Laura A. Berman, Division of Urology, UCLA Medical Center,
924 Westwood Ave., # 520, Los Angeles, CA 90024, USA.
427

428
L. A. Berman et al.
determining the overall effectiveness of an intervention, including drug
therapy, over time it does not adequately measure short-term effectiveness.
Immediate measures of intervention effectiveness are necessary because they
determine the patient’s perception of the intervention’s immediate effective-
ness on specific components of sexual function versus her overall sexual
experience over time.
THE DEVELOPMENT OF THE FEMALE INTERVENTION
EFFICACY INDEX (FIEI)
In response to the need for a more immediate, treatment-specific and physi-
ologically focused measurement, the Female Intervention Efficacy Index (FIEI)
was developed (See Appendix A). This measure consists of a 7-item mul-
tiple-choice questionnaire. Two of the questions address side effects and the
subject’s feelings about participating in the study. The remaining five ques-
tions primarily measure four variables of arousal: vaginal lubrication, amount
and quality of sensation, ability to reach orgasm, and sexual satisfaction. The
first five questions ask the patient to subjectively evaluate changes in sexual
function after administration of a treatment .
a
A Cronbach coefficient was calculated as a means of evaluating inter-
nal consistency of the FIEI measure (.81). Face validity was established through
a panel of experts and focus groups composed of female patients. This
measurement was used in several clinical trials, two of which will be pre-
sented here.
USE OF FIEI IN AN EROS-CTD STUDY
A pilot study was carried out in order to evaluate the effectiveness of the
EROS-CTD (Billups et al., in submission). This device provides gentle suction
to the clitoris and draws blood to the organ and surrounding tissue. The device
is intended to both enhance lubrication and sensation, and prevent collagen
depositions within the clitoral cavernosal smooth muscle. This is thought to
potentially increase overall blood flow to the clitoral region over time.
Methods
The study was conducted with 26 patients, 8 premenopausal and 6 post-
menopausal women with complaints of female sexual arousal disorder (FSAD),
and 4 premenopausal and 7 postmenopausal women with no sexual func-
tion complaints. The goal was to evaluate the safety and efficacy of the
EROS-CTD treatment for enhancing subjective arousal in women with SAD
in the areas of: genital sensation, vaginal lubrication, ability to reach orgasm,
and general sexual satisfaction. A complete medical history and physical

429
FIEI as Outcome Measure of FSD Treatment
examination was performed on each patient and a brief psychosexual his-
tory was taken by a sex therapist to be certain that there was a significant
medical or organic basis for the woman’s complaint. This was done because
no drug therapy or device will prove useful to a woman who’s sexual func-
tion complaints are based on relational or emotional factors. Patients who
had a history of depression, unresolved sexual abuse, hypoactive sexual
desire disorder (not caused by sexual function complaints), diabetes, dys-
pareunia, or certain other risk factors were excluded from the study.
Patients were asked to use the EROS-CTD in the privacy of their home
with or without a partner. Each patient was asked to fill out the Female
Intervention Efficacy Index (FIEI) following each home session.
Results
The results indicate improvements in lubrication, sensation and overall sexual
satisfaction. Improvements in orgasm occurred in only 50% of FSD patients.
Women without sexual response problems did not seem to reflect the same
results (See Table 1). The FIEI seemed to adequately reflect the differentiation
between women with and without FSAD for improvements with this device.
USE OF FIEI WITH SILDENAFIL STUDY
Methods
The goal of this study was to determine the effectiveness of sildenafil in
improving women’s immediate subjective sexual arousal. The sample con-
TABLE 1. Results of FIEI PostEROS-CTD Device
Response
Women w/FSAD (%)
Women w/o FSAD (%)
Sensation
More than before
Less than before
Same as before
100
0
0
78
0
22
Orgasm
More than before
Less than before
Same as before
56
0
44
40
0
60
Sexual Satisfaction
More than before
Less than before
Same as before
94
0
6
20
0
80
Lubrication
More than before
Less than before
81
0
40
0
Same as before
I couldn’t tell, partner could
13
6
50
10
Note. FASD = female sexual arousal disorder.

430
L. A. Berman et al.
sisted of 40 women (mean age, 45 years), who presented with complaints of
FSAD. This included menopausal and postmenopausal women, as well as
women who had undergone hysterectomy with or without oophorectomy or
tubal ligation. Menopausal and postmenopausal women needed to be re-
ceiving hormone replacement therapy (HRT) for at least 6 months, unless
otherwise contraindicated for medical reasons. All women were under the
care of a gynecologist or primary care physician who documented normal
Pap smears and a pelvic exam within the last year.
Women requiring antihypertensive medications or oral nitrates, and
women with history of cardiac disease or CVA were excluded from the study.
Women with other significant comorbid conditions, such as insulin depen-
dent diabetes, hypercholesterolemia, or smoking, needed to be cleared by
their internist prior to participating in the study.
All patients met with a trained sex therapist for a psychosexual history
which addressed the history of the presenting problem, basic sexual history,
relationship status and history, and earlier sexual development. This evalua-
tion was also used to confirm that all patients exhibited symptoms of sexual
arousal disorder with or without other sexual function complaints, were
comfortable with self-stimulation, and were satisfied with their or their partner’s
ability to stimulate them sexually. Data was excluded for women with unre-
solved childhood sexual abuse, relationship conflicts, or significant body
image or self esteem issues. These women were referred for ongoing indi-
vidual, couples or sexual therapy, depending on the nature of their emo-
tional or relational issues.
After a full psychosexual history was taken, a medical exam, including
pelvic exam, was performed on each patient. Patients taking seratonin re-
uptake inhibitors (SSRIs) who were stable and without symptoms of anxiety
or depression for at least 12 months were not excluded. Following the medi-
cal evaluation, all women were treated with 100 mg of sildenafil to be used
over a 6-week period of time at home. Once they completed the home
doses, patients filled out the Female Intervention Efficacy Index (FIEI), which
asked about their sexual experiences following use of sildenafil. Trends were
calculated in the form of percentages.
Results
The sample of women included a variety of racial backgrounds that served
as a good representation of the United States population. The sample con-
sisted of approximately 72% Caucasians, 12% Hispanics, and 10% African
Americans, with the remaining 6% of other racial backgrounds. Approxi-
mately 64% were Catholic, 14% were Jewish, and 22% had other religious
beliefs.
At the initial screening, patients were assessed for five baseline sexual
complaints. 100% (40) of the patients complained of problems with sexual

431
FIEI as Outcome Measure of FSD Treatment
TABLE 2. Results of FIEI Postsidenafil
Sexual activity characteristics
Vaginal lubrication
%
Responses
45
35
said more than before
said same as before or could not tell the
difference
20
said couldn’t tell the difference but their
partner could
Degree of sensation in genital area
71
29
71
29
Increased
Unchanged
Pleasant/satisfying
No different
Quality of sensation in genital area
(when felt)
Overall description of sexual activity 61
Pleasant/satisfying
22
17
67
33
71
No different than before
Pleasant but not as good as before
Increased
Unchanged
Sexual experience improved and would
continue taking medication
Ability to have an orgasm
Overall subjective impression of
the effect of medication on sexual
arousal
21
4
No change in sexual experience but would
continue medication
No change and would not continue
medication
4
Change for the worse and would not continue
medication
Overall feelings about participating
in the study
83
Positive experience, pleased with their
response
0
9
Negative experience
Happy to have contributed to scientific under-
standing of FSD
9
73
Hope to help other women with FSD
Would participate in future studies
Note. FIEI = Female Intervention Efficacy Index; FSD = female sexual dysfunction.
arousal, 88% (35) reported difficulty achieving orgasm, 62% (25) had prob-
lems of low lubrication, 40% (16) presented with numbness, and 20% (8) of
the patients presented with low desire.
Based on the results of the FIEI, several improvements were noted
postsildenafil treatment (see Table 2). An increase in genital sensation, and
an improvement in overall sexual experience was reported by 28 (71%), 27
(67%) reported an increased ability to achieve an orgasm, and 18 (45%)
reported an increase in lubrication. These results were reflected in the re-
sponse on the BISF-W in which women reported improvements in sensa-
tion, lubrication, orgasm, and satisfaction (Berman, J. et al., 2001). Further,
when results for women with and without unresolved childhood sexual abuse
(CSA) histories were separated in part of this database (Berman, L. et al.,
2001), the FIEI determined that the women with CSA histories responded
positively to sildenafil one half as often as those without abuse histories.

432
L. A. Berman et al.
CONCLUSIONS
The FIEI measure proved to be an effective, immediate subjective measure
of pharmacological intervention in sexual dysfunction. In the EROS-CTD
study, the FIEI distinguished between women with and without female sexual
function complaints. In the sildenafil study, the FIEI results coincided with
those of the BISF-W, an established, valid, and reliable measurement. It was
also able to distinguish between women with and without unresolved child-
hood sexual abuse histories.
REFERENCES
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391.
Berman, J. R., Berman, L. A., Werbin, T., Leary, N., Flaherty, E., & Goldstein, I.
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gen status on subjective and physiologic sexual responses. International Jour-
nal of Impotence Research, 11, 31–38.
Berman, J. R., Berman, L. A., Lin, H., Cantey-Kiser, J., Flaherty, N., Leahy, N., &
Goldstein, I. (2001). Effect of Sildenafil on subjective and physiologic param-
eters of the female sexual repsonse in women with sexual arousal disorder.
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Billups, K., Berman, L., Berman, J., Metz, M., Glennon, B., & Goldstein, I. (2001). A
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FIEI as Outcome Measure of FSD Treatment
APPENDIX A: THE FEMALE INTERVENTION EFFICACY INDEX
(FIEI)
FEMALE INTERVENTION EFFICACY INDEX (FIEI)
1. After taking the pill, my vaginal lubrication during intercourse and/or other sexual stimu-
lation (e.g. foreplay) was
a. more than it had been before taking the pill
b. less than it had been before taking the pill
c. same as before; no more or less
d. could not tell a difference
e. I could not tell a difference, but my partner noticed an increase
2. After taking the pill, the sensation/feeling in my genital (vagina, labia, clitoris) area during
intercourse or other sexual stimulation (e.g. foreplay) seemed to be
a. more than before
b. less than before
c. unchanged
3. If you perceived a change in sensation in your genital area, was it
a. pleasant and satisfying
b. unpleasant/disturbing
c. neither pleasant or unpleasant
d. other, please describe________________________________ _
4. After taking the pill, intercourse and/or other sexual stimulation (e.g. foreplay) was
a. pleasant and satisfying: better than before taking the pill
b. unpleasant; worse than before the pill
c. unchanged; no difference
d. pleasant; but still not like it used to be or I would like it to be
5. After taking the pill, my ability to have an orgasm was
a. increased; easier to have an orgasm
b. decreased; more difficult to have an orgasm
c. unchanged
6. Did you experience any of the following side effects after taking the pill (circle all that
apply and please state any other negative side-effects if any)?
a. nausea
b. diarrhea
c. lightheadedness
d. dizziness
e. headache
f. facial flushing
g. nasal congestion
h. abdominal pain or cramping
i. visual changes
j. nervousness; agitation
k. other_________________________________ ___
7. Overall, I feel that the pills
a. improved my sexual experience, and I would like to continue taking them
b. did not change my sexual experience, but I would like to continue taking them
c. did not change my sexual experience and I don’t want to continue taking them
d. worsened my sexual experience and I don’t want to continue taking them