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

NCT02450188 | Completed Phase 4

• 1 other identifier: ANDRO-AOUC-2014-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; PDE5 inhibitors; Cognitive-behavioral Sex Therapy

Outcome Measures

Primary Outcomes (2)

• erectile function

  we evaluate change in IIEF-15 erectile function domain from the beginning to the end of treatment (T0 vs.T2)

  Time0= at the beginning of treatment, Time 1 = after 5 weeks of treatment and Time 2= after 10 weeks of treatment

• overall satisfaction

  we evaluate change in IIEF-15 overall satisfaction domain from the beginning to the end of treatment (T0 vs.T2)

  Time0= at the beginning of treatment, Time 1 = after 5 weeks of treatment and Time 2= after 10 weeks of treatment

Study Arms (2)

vardenafil

ACTIVE COMPARATOR

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

vardenafil+cbst

ACTIVE COMPARATOR

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; Behavioral: CBST

Interventions

Vardenafil DRUG

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.

vardenafil; vardenafil+cbst

CBST BEHAVIORAL

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.

vardenafil+cbst

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Ambulatori Medicina della Sessualità e Andrologia

Florence, Italy

Location

Related Publications (5)

• Dean J, Rubio-Aurioles E, McCabe M, Eardley I, Speakman M, Buvat J, de Tejada IS, Fisher W. Integrating partners into erectile dysfunction treatment: improving the sexual experience for the couple. Int J Clin Pract. 2008 Jan;62(1):127-33. doi: 10.1111/j.1742-1241.2007.01636.x. Epub 2007 Nov 19.

  PMID: 18028387 BACKGROUND

• Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M. Structured interview on erectile dysfunction (SIEDY): a new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res. 2003 Jun;15(3):210-20. doi: 10.1038/sj.ijir.3901006.

  PMID: 12904808 BACKGROUND

• Banner LL, Anderson RU. Integrated sildenafil and cognitive-behavior sex therapy for psychogenic erectile dysfunction: a pilot study. J Sex Med. 2007 Jul;4(4 Pt 2):1117-25. doi: 10.1111/j.1743-6109.2007.00535.x.

  PMID: 17627724 BACKGROUND

• Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF, Sharlip I, Althof SE, Andersson KE, Brock G, Broderick G, Burnett A, Buvat J, Dean J, Donatucci C, Eardley I, Fugl-Meyer KS, Goldstein I, Hackett G, Hatzichristou D, Hellstrom W, Incrocci L, Jackson G, Kadioglu A, Levine L, Lewis RW, Maggi M, McCabe M, McMahon CG, Montague D, Montorsi P, Mulhall J, Pfaus J, Porst H, Ralph D, Rosen R, Rowland D, Sadeghi-Nejad H, Shabsigh R, Stief C, Vardi Y, Wallen K, Wasserman M. Summary of the recommendations on sexual dysfunctions in men. J Sex Med. 2010 Nov;7(11):3572-88. doi: 10.1111/j.1743-6109.2010.02062.x.

  PMID: 21040491 BACKGROUND

• Boddi V, Castellini G, Casale H, Rastrelli G, Boni L, Corona G, Maggi M. An integrated approach with vardenafil orodispersible tablet and cognitive behavioral sex therapy for treatment of erectile dysfunction: a randomized controlled pilot study. Andrology. 2015 Sep;3(5):909-18. doi: 10.1111/andr.12079.

  PMID: 26311340 RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Mario Maggi

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Endocrinology

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: May 21, 2015
• Study Start: March 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

IT (1)