Erectile Dysfunction Clinical Trial
Official title:
An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)
The aim of the present study is to evaluate the efficacy of a combined approach with Vardenafil orodispersible and Cognitive Behavioural Sex Therapy in the treatment of Erectile Dysfunction, compared to medical only treatment, in terms of quality and duration of erection and couple's sexual satisfaction.
This is a randomized controlled study involving 30 subjects with ED, and their partners,
seeking medical care for sexual dysfunction at Sexual Medicine and Andrology Unit of
Florence's University, Florence, Italy.
Couples were informed that both partners must attend all treatment appointments.
After signed their informed consent form, couples were randomly assigned to two different
groups (2:1 ratio), Vardenafil (Group A) or Vardenafil + CBST (Group B), using a computer
generated random code.
Couples were randomized for patient's age, partner's age and relationship span, in order to
create two homogeneous group.
The study includes a total period of 10 week with a total of 3 visits for Group A (at the
beginning, at 5th week and at the end) and with a total of 10 visits for Group B (one weekly
visit).
Ethics The ethic committee for clinical trials approved the study protocol, and all patients
and their partners provided signed, written, informed consent. The study was conducted in
accordance with regulatory standards of Good Clinical Practice and the Declaration of
Helsinki (1996).
Participants This study involved 30 male patients with ED, and their partners, both aged > 18
years and in a stable heterosexual relationship (> 6 months), seeking medical care for sexual
dysfunction at Andrology Unit of University of Florence, Florence, Italy.
Couples were excluded from participation if man had unstable medical conditions, prior pelvic
surgery or trauma, spinal cord injury, prostate surgery or radiation, diabetes mellitus,
neurogenic trauma, retinitis pigmentosa, Peyronie's disease, multiple sclerosis, substance
abuse disorder, significant mental health problems requiring psychotropic drugs, or were
receiving medication for heart disease/angina (especially nitrates) or vascular disease.
Testosterone levels has been considered normal for plasma levels ≥ 12 nmol/L and/or
calculated free testosterone≥ 225 pmol/L. When a diagnosis of hypogonadism was made, an
adequate testosterone replacement therapy was assessed.
Patients with an artheriogenic ED (assessed with peak systolic velocity at penile colour
doppler ultrasound after PGE1 stimulation, considered normal for data ≥ 25 cm/sec ) were
excluded.
The investigators also excluded couples including women with primary sexual dysfunction, as
dyspareunia, anorgasmia or vaginismus; substance abuse disorder and/or with significant
mental health problems requiring psychotropic drugs. The presence of substance abuse or
mental health problems was assessed by clinical interviews by a mental health specialist.
Study Procedures Before starting any treatment and before any specific diagnostic procedures,
male patients were interviewed by the sexual medicine specialist using SIEDY structured
interview. This is a 13-item interview previously validated which identifies and quantifies
the contribution of organic, relational and intra-psychic domains of ED.
Patients were also required to provide basic laboratory examinations (including the
evaluation of LH, total testosterone, SHBG, glycemia, FSH, TSH, total cholesterol, HDL, PSA,
PRL, triglycerides) and to perform a Colour-Doppler Ultrasound (CDU) study of penis.
After completion of this screening by the andrologist, couples were randomly assigned to
either Group A for monotherapy with Vardenafil orodispersible or to Group B for the combining
treatment with Vardenafil orodispersible and CBST.
The outline of both Group procedures is presented respectively in Table 1 and Table 2.
The CBST cognitive intervention, in according with Beck, includes to help patients and their
partners to gain a commonsense understanding and reframe their problems.
On the other side, the CBST behaviour intervention, how described by Meichenbaum, is a method
to teach patients to practice different behaviours that allows the replacement of the
compromised behaviour with a functional one.
CBST interventions used in this study includes: psycho-educational interventions on ED
maintaining, on anxiety's role and sexual homework. This course is structured in 10 weekly
meetings.
Materials All participants completed questionnaires at week 1 (before starting treatment),
week 5 (in mid of treatment) and week 10 (last session).
Both, male and female, completed the International Index of Erectile Fuction (IIEF-15), the
Index of Sexual Satisfaction (ISS) and the Middelsex Hospital Questionnaire (MHQ).
IIEF-15 was used to evaluate male erectile function (erectile function domain, EF) and both
male and female sexual satisfaction (intercourse satisfaction, IS domain, and overall
satisfaction, OS domain). In fact, even if IIEF-15 has been designed in order to evaluate
male sexual function, the investigators also asked the female partner to complete this
interview, in order to capture their perception of their partner's erectile function and
their own satisfaction.
Couple's sexual satisfaction was also assessed using the ISS, an instrument that assesses any
sexual couple's dissatisfaction. The MHQ was used to assess any underlying psychopathology in
both partners. Female partners also completed the Female Sexual Function Index (FSFI), to
assess their sexual function at the beginning and at the end of treatment. The Authors didn't
use the FSFI to exclude sexual female dysfunction because of, in according with previous
researches, women who report a partner with ED show significantly lower FSFI scores than
women who don't report ED in their partner.
Medicament In this study Vardenafil 10 mg orodispersible tablets were used. These are the
only orodispersible tablets on commerce indicated for the treatment of ED. This kind of
tablets were chosen because of their easy way of assumption that can also have a minor
psychological impact on patients.
Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10
weeks.
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