Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06376513

Evaluation of Penile Prosthesis Pump Manipulation

Led by Hospices Civils de Lyon · Updated on 2026-01-23

60

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with penetration. Unfortunately, current prostheses are difficult (or even impossible) to manipulate for some patients. Many patients underutilize their device due to difficulties in using the pump related to mechanical issues (difficult grip, lack of strength, etc.) or sensory issues (altered proprioception, etc.), resulting in an inability to achieve rigidity that allows optimal satisfaction for the patient and/or partners. These difficulties correspond to a significant portion of dissatisfaction among patients with penile prostheses. Actually, no study has evaluated patients' ability to manipulate the pump of their penile prosthesis, as well as the association between these manipulation abilities, the rigidity of erections with a penile prosthesis, and patient and partner sexual satisfaction. In this descriptive study, the primary outcome is to describe the manipulation abilities of patients with penile prostheses during follow-up consultations after prosthesis implantation. The secondary outcomes are to estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with * Rigidity of erections with penile prosthesis * Patient's sexual satisfaction * Partner's sexual satisfaction * Satisfaction related to pump manipulation

CONDITIONS

Official Title

Evaluation of Penile Prosthesis Pump Manipulation

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults
  • Diagnosed with erectile dysfunction and had penile prosthesis implantation more than 3 months ago
  • Able to understand the nature and purpose of the research
  • Have provided informed consent
  • Partners of eligible patients must be adults
  • Partners must understand the nature and purpose of the research
  • Partners must have provided informed consent
Not Eligible

You will not qualify if you...

  • Patients with a dysfunctional penile prosthesis (problems with reservoir, pump, or cylinders)
  • Adults under legal protective measures
  • Individuals not affiliated with a social security scheme or similar beneficiaries

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Urology, Lyon Sud Hospital,

Pierre-Bénite, France, 69310

Actively Recruiting

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Research Team

N

Nicolas MOREL-JOURNEL

CONTACT

C

clément PARAT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Evaluation of Penile Prosthesis Pump Manipulation | DecenTrialz