Tumescent Stretching Measurement Technique (TSMT)

Cairo University (CU)

Status: Unknown

Conditions: To Try to Eliminate Frequencies of Insertions in Order to Arrive to Adequate Size of Implanted Penile Prosthesis

Treatments: Procedure: Tumescent Stretching Measurement Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04864301

TSMT

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 21 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Tumescent Stretching Measurement Technique

Active Comparator group

Description:

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.

Treatment:

Procedure: Tumescent Stretching Measurement Technique

Conventional Measurement technique

Active Comparator group

Description:

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.

Treatment:

Procedure: Tumescent Stretching Measurement Technique