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Vardenafil and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV) (STEDOV)

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ClinicalTrials.gov Identifier: NCT02450188
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Mario Maggi, University of Florence

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Vardenafil Behavioral: CBST Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)
Study Start Date : March 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vardenafil

Arm Intervention/treatment
Active Comparator: vardenafil
The study includes a total period of 10 week with a total of 3 visits for vardenafil Group (at the beginning, at 5th week and at the end). In this study we used Vardenafil 10 mg orodispersible tablets. These are the only orodispersible tablets on commerce indicated for the treatment of ED. Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10 weeks.
Drug: Vardenafil

In this study we used Vardenafil 10 mg orodispersible tablets. These are the only orodispersible tablets on commerce indicated for the treatment of ED. We choose this kind of tablets 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.


Active Comparator: vardenafil+cbst

The study includes a total period of 10 week with a total of 10 visits for vardenafil+cbst Group (one weekly visit).

Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10 weeks.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.

Drug: Vardenafil

In this study we used Vardenafil 10 mg orodispersible tablets. These are the only orodispersible tablets on commerce indicated for the treatment of ED. We choose this kind of tablets 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.


Behavioral: CBST

The CBST cognitive intervention, in according with Beck (1976), 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 (1993), 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. Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10 weeks.





Primary Outcome Measures :
  1. erectile function [ Time Frame: Time0= at the beginning of treatment, Time 1 = after 5 weeks of treatment and Time 2= after 10 weeks of treatment ]
    we evaluate change in IIEF-15 erectile function domain from the beginning to the end of treatment (T0 vs.T2)

  2. overall satisfaction [ Time Frame: Time0= at the beginning of treatment, Time 1 = after 5 weeks of treatment and Time 2= after 10 weeks of treatment ]
    we evaluate change in IIEF-15 overall satisfaction domain from the beginning to the end of treatment (T0 vs.T2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • We 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450188


Locations
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Italy
Ambulatori Medicina della Sessualità e Andrologia
Florence, Italy
Sponsors and Collaborators
University of Florence
Investigators
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Principal Investigator: Mario Maggi University of Florence

Publications of Results:
Other Publications:
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Responsible Party: Mario Maggi, Full Professor of Endocrinology, University of Florence
ClinicalTrials.gov Identifier: NCT02450188     History of Changes
Other Study ID Numbers: ANDRO-AOUC-2014-02
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Keywords provided by Mario Maggi, University of Florence:
Erectile Dysfunction
PDE5 inhibitors
Cognitive-behavioral Sex Therapy
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents