Penile Prosthesis; ComplicationsPhase 2NCT03614429
Urethral Sterilization With Chlorhexidine Digluconate to Facilitate Primary Repair & Same-Session Implantation
A Phase 2 study testing Chlorhexidine gel will be prepared according to an international product Instillagel® in people with Penile Prosthesis; Complications, run by Cairo University at 1 site in Egypt.
Trial summary
The introduction of penile implants has revolutionized the management of male erectile dysfunction. However, a number of intraoperative complications may occur, which have a major impact on clinical outcomes and patient satisfaction such as bleeding, infection and urethral injury. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men only
- Conditions the study is for
- Penile Prosthesis; Complications
- What is being tested?
- Chlorhexidine gel will be prepared according to an international product Instillagel®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 1 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure
Who cannot join
- Unwilling patient for this procedure
- Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Andrology department - Kasr El Aini Hospitals - Faculty of Medicine - Cairo University
Cairo, 11553
About this study
Official title: Management of Urethral Injury During Penile Prosthesis Implantation: Urethral Sterilization With Chlorhexidine Digluconate to Facilitate Primary Repair and Same-Session Implantation
The introduction of penile implants has revolutionized the management of male erectile dysfunction. However, a number of intraoperative complications may occur, which have a major impact on clinical outcomes and patient satisfaction such as bleeding, infection and urethral injury.
Patients undergoing penile implant surgery with fibrotic corpora (e.g., after priapism, after infection, or with Peyronie disease) have a higher risk rates of urethral perforation. This may be related to previous scarring, the difficultly in dilating scarred and fibrotic corpora and its inherent risk of corporal crossover and urethral perforation.
Read more
This work examines the efficacy of pre-operative urethral sterilization in rendering the urethra as sterile as the skin of the genital area, with the skin sterilized as per the ISSM guidelines for penile prosthesis implantation, thereby allowing primary repair of urethral injuries should they occur, and implantation in the same setting, without a higher risk of infection.
The study will involve 100 male patients undergoing aseptic surgery (regardless the procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50 Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained:
- A penile skin swab.
- A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by culture and sensitivity, across the two groups.
Read the detailed description
study design Comparative experimental (interventional) study Sample size
The study will involve 100 male patients undergoing aseptic surgery (regardless the procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50
Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
Chlorhexidine gel will be prepared according to an international product; Instillagel®, used prior to urethral catheterization as analgesic / anti-septic, with the following composition:
6ml of Instillagel® gel contain: 117.6mg lidocaine hydrochloride, 3.1mg chlorhexidine digluconate, 3.8mg methyl hydroxybenzoate (E218), 1.6mg propyl hydroxybenzoate (E216) 11ml of Instillagel® gel contain: 215.7mg lidocaine hydrochloride, 5.8mg chlorhexidine digluconate, 6.9mg methyl hydroxybenzoate (E218), 2.9mg propyl hydroxybenzoate (E216)
The other ingredients are:
Hyetellose, propylene glycol* (E 1520), sodium hydroxide and purified water. Intra-operatively, the Ch group will receive Chlorhexidine instillation again before surgery, while the control group will not.
For both groups, skin sterilization will be performed according to the ISSM "International Society of Sexual Medicine" guidelines for skin preparation before penile prosthesis surgery (Darren J. Katz et.al 2012)
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained:
- A penile skin swab.
- A urethral swab.
- Conditions
- Penile Prosthesis; Complications
- Being tested
- Chlorhexidine gel will be prepared according to an international product Instillagel®
- Keywords
- Penile Prosthesis, Urethral injury, Urethral sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gel will be prepared according to an international product Instillagel®Drug
Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
Chlorhexidine gel will be prepared according to an international product; Instillagel®, used prior to urethral catheterization as analgesic / anti-septic, with the following composition:
6ml of Instillagel® gel contain: 117.6mg lidocaine hydrochloride, 3.1mg chlorhexidine digluconate, 3.8mg methyl hydroxybenzoate (E218), 1.6mg propyl hydroxybenzoate (E216) 11ml of Instillagel® gel contain: 215.7mg lidocaine hydrochloride, 5.8mg chlorhexidine digluconate, 6.9mg methyl hydroxybenzoate (E218), 2.9mg propyl hydroxybenzoate (E216)
The other ingredients are:
Hyetellose, propylene glycol* (E 1520), sodium hydroxide and purified water. Intra-operatively, the Ch group will receive Chlorhexidine instillation again before surgery, while the control group will not.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Group 1: control group, n=50 Male patients undergoing aseptic surgery (regardless the procedure) Inclusion criteria Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure. Exclusion criteria Unwilling patient for this procedure Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage. |
| Ch group | Experimental | Group 2: Chlorhexidine group (Ch group), n=50 Male patients undergoing aseptic surgery (regardless the procedure)
Inclusion criteria Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure.
Exclusion criteria Unwilling patient for this procedure Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage. Receives: Drug: Chlorhexidine gel will be prepared according to an international product Instillagel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colonization by culture and sensitivity
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained:
- A penile skin swab.
- A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by culture and sensitivity, across the two groups.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jun 2018
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Prosthesis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative experimental (interventional) controlled study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Kamal Shaeer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614429
- Sponsor's protocol ID
- 1-4-2018
- Status last verified
- Aug 2018
- First submitted
- 29 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Urethral Injury During Penile Prosthesis Implantation: Urethral Sterilization With Chlorhexidine Digluconate to Facilitate Primary Repair and Same-Session Implantation
- ClinicalTrials.gov ID
- NCT03614429
- Acronym / sponsor ID
- 1-4-2018
- Conditions
- Penile Prosthesis; Complications
- Keywords
- Penile Prosthesis, Urethral injury, Urethral sterilization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The introduction of penile implants has revolutionized the management of male erectile dysfunction. However, a number of intraoperative complications may occur, which have a major impact on clinical outcomes and patient satisfaction such as bleeding, infection and urethral injury.
Patients undergoing penile implant surgery with fibrotic corpora (e.g., after priapism, after infection, or with Peyronie disease) have a higher risk rates of urethral perforation. This may be related to previous scarring, the difficultly in dilating scarred and fibrotic corpora and its inherent risk of corporal crossover and urethral perforation.
This work examines the efficacy of pre-operative urethral sterilization in rendering the urethra as sterile as the skin of the genital area, with the skin sterilized as per the ISSM guidelines for penile prosthesis implantation, thereby allowing primary repair of urethral injuries should they occur, and implantation in the same setting, without a higher risk of infection.
The study will involve 100 male patients undergoing aseptic surgery (regardless the procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50 Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained:
- A penile skin swab.
- A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by culture and sensitivity, across the two groups.
Detailed description
study design Comparative experimental (interventional) study Sample size
The study will involve 100 male patients undergoing aseptic surgery (regardless the procedure). Patients will be divided into two groups:
Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50
Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
Chlorhexidine gel will be prepared according to an international product; Instillagel®, used prior to urethral catheterization as analgesic / anti-septic, with the following composition:
6ml of Instillagel® gel contain: 117.6mg lidocaine hydrochloride, 3.1mg chlorhexidine digluconate, 3.8mg methyl hydroxybenzoate (E218), 1.6mg propyl hydroxybenzoate (E216) 11ml of Instillagel® gel contain: 215.7mg lidocaine hydrochloride, 5.8mg chlorhexidine digluconate, 6.9mg methyl hydroxybenzoate (E218), 2.9mg propyl hydroxybenzoate (E216)
The other ingredients are:
Hyetellose, propylene glycol* (E 1520), sodium hydroxide and purified water. Intra-operatively, the Ch group will receive Chlorhexidine instillation again before surgery, while the control group will not.
For both groups, skin sterilization will be performed according to the ISSM "International Society of Sexual Medicine" guidelines for skin preparation before penile prosthesis surgery (Darren J. Katz et.al 2012)
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained:
- A penile skin swab.
- A urethral swab.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative experimental (interventional) controlled study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Group 1: control group, n=50 Male patients undergoing aseptic surgery (regardless the procedure) Inclusion criteria Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure. Exclusion criteria Unwilling patient for this procedure Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage. |
| Ch group | Experimental | Drug: Chlorhexidine gel will be prepared according to an international product Instillagel®Group 2: Chlorhexidine group (Ch group), n=50 Male patients undergoing aseptic surgery (regardless the procedure) Inclusion criteria Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure. Exclusion criteria Unwilling patient for this procedure Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male patients aged 20-50 years-old or older undergoing a sterile surgical procedure
Key exclusion criteria (2 listed)
- Unwilling patient for this procedure
- Patients with history of urethral surgery, urinary calculi, urethral structure, or ongoing pyospermia, prostatitis or pyuria will be excluded, and so will be patients undergoing non-sterile surgeries such as abscess drainage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gel will be prepared according to an international product Instillagel®Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed. Chlorhexidine gel will be prepared according to an international product; Instillagel®, used prior to urethral catheterization as analgesic / anti-septic, with the following composition: 6ml of Instillagel® gel contain: 117.6mg lidocaine hydrochloride, 3.1mg chlorhexidine digluconate, 3.8mg methyl hydroxybenzoate (E218), 1.6mg propyl hydroxybenzoate (E216) 11ml of Instillagel® gel contain: 215.7mg lidocaine hydrochloride, 5.8mg chlorhexidine digluconate, 6.9mg methyl hydroxybenzoate (E218), 2.9mg propyl hydroxybenzoate (E216) The other ingredients are: Hyetellose, propylene glycol* (E 1520), sodium hydroxide and purified water. Intra-operatively, the Ch group will receive Chlorhexidine instillation again before surgery, while the control group will not. | Drug | Ch group |
Primary outcome
Bacterial colonization by culture and sensitivity
Time frame: 4 days
After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained: * A penile skin swab. * A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by culture and sensitivity, across the two groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorhexidine gel will be prepared according to an international product Instillagel® in people with Penile Prosthesis; Complications, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama K Shaeer, M.D., PhD (+201006600606, osamashaeer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial colonization by culture and sensitivity (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.