Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04390230

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

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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

CHU de Nice

Nice, 06300, France

Location status: Recruiting

Location contact

Lionel MENDEL

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Penile prostheses implantation

Procedure

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

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. to show a correlation between easy handling and post-operative satisfaction

    Time frame: 3 months

    statistical correlation between easy handling and post-operative satisfaction

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

    Time frame: 3 months

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

Study contacts

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

Aysha SHAIKH

CONTACT

[email protected]

Lionel MENDEL, MD

CONTACT

[email protected]

00 33 (0)6 24 25 01 03

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Inflatable Penile Prostheses : Predicting Factors of Pump Misuse and Unsatisfaction

Important dates

Study start
2014
Primary completion
2020
Study completion
2027
First posted
May 15, 2020
Registry last updated
Jun 29, 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.

Published trials that share one or more normalized conditions with this study.