Tumescent Stretching Measurement Technique

Not Applicable

• Conditions: To Try to Eliminate Frequencies of Insertions in Order to Arrive to Adequate Size of Implanted Penile Prosthesis
• Interventions: Procedure: Tumescent Stretching Measurement Technique

• Registration Number: NCT04864301
• Lead Sponsor: Cairo University

Brief Summary

Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length by stretching the tumesncent penis intraoperatively instead of taking proximla and distal measurement to the corporotomy

Detailed Description

Objectives:

Introducing and evaluating the accuracy of a novel method for estimating inflatable penile prosthesis cylinders length.

Methods:

24 patients undergoing a Coloplast Titan ® Touch implantation procedure will berandomly divided into two groups.

The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will be stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.

The control group (N=12) will receive no intraoperative ICI. Following maximal corporal dilatation, cylinder length will be estimated by adding up the internally measured distal and proximal corpora to the length of the corporotomy.

Implants are deemed correctly sized when cylinders reached the proximal third of the glans with no buckling of cylinders or floppy glans.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-24
• Study First Submitted QC: 2021-04-24
• Last Update Submitted: 2021-04-24
• Study First Posted: 2021-04-28
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Males needing Penile implant surgery, not responding to oral pharmacological drugs for ttt of ED -

Exclusion Criteria

Previouys penile surgery Previous implanted penile prosthesis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Measurement technique	Tumescent Stretching Measurement Technique	The control group (N=12) will receive no intraoperative ICI. Following maximal corporal dilatation, cylinder length will be estimated conventionally by adding up the internally measured distal and proximal corpora to the length of the corporotomy.
Tumescent Stretching Measurement Technique	Tumescent Stretching Measurement Technique	The "Tumescent Stretching Measurement Technique" (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus.

Primary Outcome Measures

Name	Time	Method
Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size	Intraoperative	Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt