Is penile prosthesis implantation for severe male impotence a satisfactory treatment for both patient and sexual partner and why?

Active, not recruiting

• Conditions: Refractory erectile dysfunction; Renal and Urogenital - Other renal and urogenital disorders; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12612000235808
• Lead Sponsor: Aristotle University of Thessaloniki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1.Patients with refractory to oral and intracavernosal injection treatment erectile dysfunction not allowing sexual intercourse .
2.Contraindication for oral and intracavernosal injection treatment for patients with erectile dysfunction not allowing sexual intercourse.
3.Unwilling for oral and intracavernosal injection treatment patients with erectile dysfunction not allowing sexual intercourse.
4. Patients with refractory to oral treatment erectile dysfunction not allowing sexual intercourse, who do not wish to receive intracavernosal injections

Exclusion Criteria

1.Patients with erectile dysfunction safely curable by oral or intracavernosal injection treatment
2.Patients, who despite their refractory erectile dysfunction in oral and intracavernosal injection treatment, can have sexual intercourse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction of patients with refractory erectile dysfunction and their sexual partners, after penile prosthesis implantation by using the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS) Patient and Partner Versions[Patients fill up questionnaires on 12th, 24th and 36th month postoperatively];Correlation between patients and partners sexual satisfaction by statistical analysis[Patients fill up questionnaires on 12th, 24th and 36th month postoperatively];Assessment of various predicting factors resulting in patients satisfaction or dissatisfaction by using EDITS questionnaire[Patients fill up questionnaires on 12th, 24th and 36th month postoperatively]

Secondary Outcome Measures

Name	Time	Method
Surgical complications after the operation using the modified Clavien System.[All the complications are going to be recorded during the early and late postoperatively day. On dishcarge day and in 30 days postoperatively.];Long term complications of the penile prothesis. Mechanical failure, fracture, infection, revision surgery, withdrawl, exchange.[On 24th, 36th, 48th month postoperatively.]