Evaluation of Penile Prosthesis Pump Manipulation

NCT06376513 | Recruiting

• 1 other identifier: 69HCL24_0031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Penile Prosthesis

Keywords

Erectile dysfunction; Penile prosthesis; Manipulation difficulties; Erection's rigidity; Sexual satisfaction

Outcome Measures

Primary Outcomes (5)

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

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

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

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

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

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

• Describing the manipulation abilities of patients with penile prosthesis : proprioception

  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.

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

• Describing the manipulation abilities of patients with penile prosthesis :discrimination

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

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

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

  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.

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

Secondary Outcomes (5)

• Correlation of manipulation parameters (main outcome) with rigidity of erections

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

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

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

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

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

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

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

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

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

Study Arms (1)

Patients who have undergone penile prosthesis implantation > 3 months ago and their partner

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

Other: Evaluation

Interventions

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

Patients who have undergone penile prosthesis implantation > 3 months ago and their partner

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient with penile prosthesis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to comprehend the nature and purpose of the research
• Having provided informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Department of Urology, Lyon Sud Hospital,

Pierre-Bénite, 69310, France

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Orgasm

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nicolas MOREL-JOURNEL

CONTACT

+ 33 4 72 6788 37; nicolas.morel-journel@chu-lyon.fr

clément PARAT

CONTACT

+ 33 4 72 6788 37; clement.parat@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 19, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (1)