Clinical trial NCT00731666: Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)
Official title: Prospective, Non-randomized, Multi-center Clinical Trial to Assess the Effectiveness of the Coloplast Titan® IPP at Maintaining or Increasing Penile Length After Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: penile length
IPP
Erectile dysfunction
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 40
Sex: MALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the effectiveness of the Coloplast Titan® Inflatable Penile Prosthesis (IPP) at maintaining or increasing penile length after implantation of the device. It will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation.


Eligibility criteria: Inclusion Criteria:

* Has an estimated life expectancy of more than 5 years
* Has been diagnosed with erectile dysfunction
* Is willing to have the Titan IPP implanted
* Is able and willing to complete all follow-up visits and procedures indicated in this protocol
* Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site

Exclusion Criteria:

* Participant has had a previous penile prosthesis or prior penile enlargement surgeries
* Participant has a compromised immune system
* Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
* Participant does not have manual dexterity or mental ability to operate the pump
* Participant has an active urogenital infection or active skin infection in region of surgery
* Participant is diagnosed with fibrotic disease, such as priapism or Peyronie's disease
* Participant is diagnosed with Chordee
* Participant has neuropathy
* Participant has a serious bleeding disorder or coagulopathy

Primary outcomes:
measure: The Study's Primary Objective Will Assess the Change in Penile Length.
timeFrame: 12 months
Secondary outcomes:
measure: Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.
timeFrame: 12 and 24 months
measure: The Rate of Change in Male Stress Urinary Incontinence(SUI).
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A Haley VA
state: Florida
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: Regional Urology, LLC
name: Gerard Henry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JAames A Haley VA
name: Rafael Carrion, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Run Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry GD, Carrion R, Jennermann C, Wang R. Prospective evaluation of postoperative penile rehabilitation: penile length/girth maintenance 1 year following Coloplast Titan inflatable penile prosthesis. J Sex Med. 2015 May;12(5):1298-304. doi: 10.1111/jsm.12833. Epub 2015 Apr 14.