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NCT Number: NCT06376513

Evaluation of Penile Prosthesis Pump Manipulation

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

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Key information

Conditions

Penile Prosthesis Behavior Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Orgasm Sexual Behavior Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients will be included based on the following criteria:
  • Adults
  • Erectile Dysfunction, and had undergone penile prosthesis implantation for more than 3 months
  • Able to comprehend the nature and purpose of the research
  • Having provided informed consent

The partner will be included based on the following criteria :

  • Adults
  • Having a partner who meets the inclusion criteria
  • Able to comprehend the nature and purpose of the research
  • Having provided informed consent

Exclusion criteria

  • Patients with a dysfunctional penile prosthesis (reservoir, pump, or cylinders anomaly)
  • Adults subject to legal protective measures.
  • Individuals not affiliated with a social security scheme or beneficiaries of a similar scheme.

Treatment and study plan

Evaluation

Other

Evaluation of the manipulation abilities of patients with penile prostheses Evaluation of the rigidity of erections with penile prosthesis, the patient and partner's sexual satisfaction, the satisfaction related to pump manipulation

Primary outcomes

  1. Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    Measurement of overall hand grip strength using the JAMAR dynamometer. The force is expressed in kg.

  2. Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    Measurement of pinch grip strength using the "pinch test".The force is expressed in kg.

  3. Describing the manipulation abilities of patients with penile prosthesis : proprioception

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    Measurement of proprioception with a object recognition test : the "Moberg pick-up test".

    The patient must recognize (with eyes closed) objects that he has previously seen and held in his hand. A score ranging from 0 to 12 will thus be obtained.

  4. Describing the manipulation abilities of patients with penile prosthesis :discrimination

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    Measurement of discrimination with a two points touch test. Evaluation of the smallest perceived distance between two points, expressed in mm.

  5. Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    Evaluation of upper limb function for activities of daily living: the Quick DASH (Disabilities of the Arm, Shoulder and Hand).

    A score ranging from 11 to 55 will thus be obtained.

Secondary outcomes

  1. Correlation of manipulation parameters (main outcome) with rigidity of erections

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    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.

    The patient will be asked to inflate his prosthesis under normal usage conditions. The physician will then apply the device to the erect penis and note the point of deformation of the penis (buckling). The result is expressed in grams.

    Manipulation of the penile prosthesis pump resulting in an erection rigidity exceeding 550g will be considered adequate

  2. Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with patient's sexual satisfaction (modified EDITS).

    The responses to the EDITS questionnaire are given on a Likert scale ranging from 0 to 4 for each item. A score of 0 corresponds to maximum dissatisfaction, and a score of 4 corresponds to maximum satisfaction. A score ranging from 0 to 36 will thus be obtained. For each item, satisfaction is deemed sufficient if the Likert score obtained is ≥ 3.

  3. Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with patient's sexual satisfaction ( QoLSPP).

    The responses to the QoLSPP questionnaire are given on a Likert scale ranging from 0 to 5 for each item. A score of 0 corresponds to maximum dissatisfaction, and a score of 5 corresponds to maximum satisfaction. A score ranging from 0 to 80 will thus be obtained. For each item, satisfaction is deemed sufficient if the Likert score obtained is ≥ 3.

  4. Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with partner's sexual satisfaction (partner modified EDITS)

    The responses to the partner EDITS questionnaire are given on a Likert scale ranging from 0 to 4 for each item. A score of 0 corresponds to maximum dissatisfaction, and a score of 4 corresponds to maximum satisfaction. A score ranging from 0 to 20 will thus be obtained. For each item, satisfaction is deemed sufficient if the Likert score obtained is ≥ 3.

  5. Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire)

    Time frame: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)

    To estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with satisfaction related to pump manipulation (self-made questionnaire)

    The responses to this questionnaire will also be provided on a Likert scale ranging from 0 to 4 for each item. A score of 0 corresponds to complete inability to perform the act, and a score of 4 corresponds to performing the act without any difficulty. A score ranging from 0 to 24 will thus be obtained. For each item, satisfaction related to pump manipulation is deemed sufficient if the Likert score obtained is ≥ 3.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas MOREL-JOURNEL

CONTACT

[email protected]

+ 33 4 72 6788 37

clément PARAT

CONTACT

[email protected]

+ 33 4 72 6788 37

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ECM3P

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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