TSMT: Tumescent Stretching Measurement Technique

• Sponsor: Cairo University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04864301
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
To Try to Eliminate Frequencies of Insertions in Order to Arrive to Adequate Size of Implanted Penile Prosthesis	Procedure: Tumescent Stretching Measurement Technique	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Tumescent Stretching Measurment Technique: A New Technique for Intraoperartive Measurement of Inflatable Penile Implant Size
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 79 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adham ZAAZAA, Associate Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04864301
• Other Study ID Numbers: TSMT
• First Posted: Apr 28, 2021
• Last Update Posted: Apr 28, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Adham ZAAZAA, Associate Professor, Cairo University: penile implant, iflatable penile implant, re-insertion, measurement

Study Results

No Results Posted as of Apr 28, 2021