Penile ProsthesisECM3PNCT06376513
Evaluation of Penile Prosthesis Pump Manipulation
A study testing Evaluation in people with Penile Prosthesis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Prosthesis
- What is being tested?
- Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2024to 14 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
Show all 10Show fewer
- Adults
- Having a partner who meets the inclusion criteria
- Able to comprehend the nature and purpose of the research
- Having provided informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Department of Urology, Lyon Sud Hospital,
Pierre-Bénite, 69310
Nicolas MOREL, + 33 4 72 6788 37, nicolas.morel-journel@chu-lyon.fr
Clément PARAT, + 33 4 72 6788 37, clement.parat@chu-lyon.fr
About this study
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.
Read more
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
- Being tested
- Evaluation
- Keywords
- Erectile dysfunction, Penile prosthesis, Manipulation difficulties, Erection's rigidity, Sexual satisfaction
- Medical subject headings
- Erectile Dysfunction, Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: At inclusion (during a standard of care follow-up consultation from 3 months post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start14 Jun 2024
- Primary completion14 Dec 2026 (estimated)
- Study completion14 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile ProsthesisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376513
- Sponsor's protocol ID
- 69HCL24_0031
- Acronym
- ECM3P
- Status last verified
- Jan 2026
- First submitted
- 15 Apr 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Penile Prosthesis Pump Manipulation
- ClinicalTrials.gov ID
- NCT06376513
- Acronym / sponsor ID
- ECM3P / 69HCL24_0031
- Conditions
- Penile Prosthesis
- Keywords
- Erectile dysfunction, Penile prosthesis, Manipulation difficulties, Erection's rigidity, Sexual satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 14 Dec 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have undergone penile prosthesis implantation > 3 months ago and their partner | Other | Other: EvaluationEvaluation 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvaluationEvaluation 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 | Patients who have undergone penile prosthesis implantation > 3 months ago and their partner |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation in people with Penile Prosthesis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas MOREL-JOURNEL (+ 33 4 72 6788 37, nicolas.morel-journel@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.