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Tumescent Stretching Measurement Technique

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04864301
Acronym
TSMT
Enrollment
24
Registered
2021-04-28
Start date
2019-01-01
Completion date
2021-05-01
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

penile implant, iflatable penile implant, re-insertion, measurement

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.

Interventions

PROCEDURETumescent 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
21 Years to 79 Years
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 \-

Design outcomes

Primary

MeasureTime frameDescription
Number of penile implant insertions and re-insertions needed to arrive to adequate penile implant sizeIntraoperativeNumber of penile implant insertions and re-insertions needed to arrive to adequate penile implant size

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026