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N/A N=40 Treatment

Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)

Erectile Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT00731666 ↗
Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Nov 2013
Primary outcome: Primary: The Study's Primary Objective Will Assess the Change in Penile Length. — 1.14; 0.99; 1.04; 0.94 cm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Inflatable Penile Prosthesis (Device)
Age
Adult, Older Adult · 25+ yrs
Sex
Male
Sponsor
Coloplast A/S
Primary completion
May 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
The Study's Primary Objective Will Assess the Change in Penile Length.		 1.14; 0.99; 1.04; 0.94; 0.69; 0.59 —
SECONDARY
Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.		 48.4; 16.1; 22.6; 12.9; 57.1; 10.7 —
SECONDARY
The Rate of Change in Male Stress Urinary Incontinence(SUI).		 16.7; 66.7; 16.7; 12.9; 61.3; 25.8 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00731666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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