Tumescent Stretching Measurement Technique (TSMT)

Tumescent Stretching Measurment Technique: A New Technique for Intraoperartive Measurement of Inflatable Penile Implant Size

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

Study Overview

• Status: Active, not recruiting
• Conditions: To Try to Eliminate Frequencies of Insertions in Order to Arrive to Adequate Size of Implanted Penile Prosthesis
• Intervention / Treatment: Procedure: Tumescent Stretching Measurement Technique

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: 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.
ACTIVE_COMPARATOR: Conventional 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size	Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant size	Intraoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: April 24, 2021
• First Posted (ACTUAL): April 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 24, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: penile implant, iflatable penile implant, re-insertion, measurement
• Other Study ID Numbers: TSMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes