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SurgeryNCT04390230

Inflatable Penile Prostheses : Which Patients Can Correctly Use the Scrotal Pump ?

An observational study of Surgery and Satisfaction, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Sexual health and satisfaction are well know as critical critera to assess quality of life, at any age. Among the multiple aspects of sexual health, erectile dysfunction (ED) is not anymore a fate, mainly thanks to the advent of phosphodiesterase type 5 (PDE5) inhibitors in 1998. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Penile prostheses implantation
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteFrance
Study dates
24 Jan 2014to 25 Jun 2027
Phase
Observational
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

Study population: All patients who underwent implantation with either Coloplast or Boston Scientific - AMS IPPs between 2014 and 2019, by 2 surgeons of the University Hospital of Nice, France.

All cases included were discussed and approved by a multidisciplinary team. Patients who underwent prosthesis replacement or second implantation were not included. We excluded patients who refused or were not able to answer our questionnaire, patients who provided unreliable answers, and patients that experimented a secondary malfunction of their IP.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aysha SHAIKH contact

shaikh.a@chu-nice.fr

France1 site, 1 recruiting
  • CHU de Nice

    Nice, 06300

    Lionel MENDEL

    Recruiting

Other trials in France

About this study

Official title: Inflatable Penile Prostheses : Predicting Factors of Pump Misuse and Unsatisfaction

Sexual health and satisfaction are well know as critical critera to assess quality of life, at any age. Among the multiple aspects of sexual health, erectile dysfunction (ED) is not anymore a fate, mainly thanks to the advent of phosphodiesterase type 5 (PDE5) inhibitors in 1998. Nevertheless, a significant part of patients are intolerant or does not respond to PDE5 inhibitors and thus are looking for other treatment options.

Since the first implantation of foreign material intracarvernosally in 1966 by Beheri, multiple modifications and enhancements were achieved in order to produce devices more reliable with a more natural appearance. First introduced in 1973 by Scott et al., inflatable prosthesis provides now high general satisfaction rates (69-94%), better than in malleable prostheses, except for few authors.

Read more

In addition to changes in materials and construction, the two main manufacturers of IPP, Boston scientific AMS (Marlborough, MA, USA) and Coloplast (Minneapolis, MN, USA), modernized the pump mechanism of their devices. Since the introduction of AMS IPP, three main pump formats have been used : the standard pump has been replaced in 2004 by the " Tactile " pump and then the " Momentary Squeeze " (MS) pump in 2006, smaller and easier to deflate by not requiring the patient to hold the deflation button throughout deflation. Coloplast also replaced in 2008 their " Genesis " pump by a " One Touch Release " (OTR) pump, and finally in 2014 by the current " Touch " pump, smaller, and presenting a biconcave deflation button, easier to find.

Despite all technological advances, appropriate pre-operative counselling and careful post-operative teachning, a significant part of patients has still difficulties to handle the pump and thus, does not use their IPP, regardless of any material malfunction. That situation obviously leads to patient's dissatisfaction and highlights the operating risks of a useless surgical procedure.

The purposes of this study were:to identify the risks factors, modifiable and non-modifiable, for patients' difficulty to inflate and/or deflate their device after IPP implantation, then to show a correlation between easy handling and post-operative satisfaction. And last but not least, to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling. That information could help the physicians to improve the pre-operative selection of patients and to adapt the peri-operative care in order to improve patients satisfaction.

Being tested
Penile prostheses implantation
Medical subject headings
Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Penile prostheses implantationProcedure or surgery

    Penial implantation with either Coloplast or Boston Scientific - AMS IPPs between 2014 and 2019, by 2 surgeons of the University Hospital of Nice, France

Study groups in NCT04390230
Study groupRoleWhat they receive
Patient with peniale implantationAll patients who underwent implantation with either Coloplast or Boston Scientific - AMS IPPs between 2014 and 2019, by 2 surgeons of the University Hospital of Nice, France.
Receives: Procedure: Penile prostheses implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to identify the risks factors, modifiable and non-modifiable, for patients' difficulty to inflate and/or deflate their device after IPP implantation.

    the statistical association between pump misusing, and a range of potentially relevant factors such as ages, BMI, model pump, inappropriate positionning or post operative complications

    Measured: 3 months

Secondary outcomes (2)
  1. to show a correlation between easy handling and post-operative satisfaction

    statistical correlation between easy handling and post-operative satisfaction

    Measured: 3 months

  2. to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling

    statistical association between pre-operative pump pattern viewing and handling and post-operative easy handling.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start24 Jan 2014
  3. Primary completion1 May 2020
  4. Study completion25 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04390230
Sponsor's protocol ID
20Urobase01
Status last verified
Jun 2026
First submitted
12 May 2020
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No data sharing plan has been established.

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Satisfaction, run by Centre Hospitalier Universitaire de Nice 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?

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 29 Jun 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 Lionel MENDEL, MD (00 33 (0)6 24 25 01 03, mendel.l@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to identify the risks factors, modifiable and non-modifiable, for patients' difficulty to inflate and/or deflate their device after IPP implantation. (time frame: 3 months). 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 29 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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