Complication of Surgical ProcedureNCT03313986
Outcomes of Surgical Correction of Penile Curvature in Adult
An observational study of Complication of Surgical Procedure, run by Assiut University.
Trial summary
Penile curvature in adults is divided into two main categories the first is congenital penile curvature with orthotopic meatus and the other is acquired curvature which its common causes are Peyronie's disease (PD) and previous penile surgery as for hypospadias repair.The congenital penile curvatures (CPC) which not… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Complication of Surgical Procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Dec 2020
- Phase
- Observational
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All patients with penile curvature with failure of conservative/medical treatment (nonsurgical treatment) and patient's preference for definite results According to exclusion and inclusion criteria Attending Assiut andrology outpatient clinic.
Who may be able to join
- penile curvature more than 30degree.
Who cannot join
- Age: less than 18 years.
- Non-orthotopic meatus
- Patients with ED.
Trial locations and contacts
No sites are listed yet.
About this study
Penile curvature in adults is divided into two main categories the first is congenital penile curvature with orthotopic meatus and the other is acquired curvature which its common causes are Peyronie's disease (PD) and previous penile surgery as for hypospadias repair.The congenital penile curvatures (CPC) which not associated with urethral malformation is a relatively uncommon condition that may present in late adolescent or early adult life. The incidence is estimated to be 0.6 % but the incidence of clinically significant CPC is much lower, as the degree of curvature and sexual dysfunction varies widely Penile curvature may lead to inability for sexual intercourse. These cases require treatment. Acquired penile curvature its most common cause is Peyronie's disease. Peyronie's disease is a fibrotic disorder of the tunica albuginea of the corpora cavernosa that is clinically defined by the presence of a palpable, inelastic tunical plaque. PD is relatively common and affects up to 20.3% of adult men to some degree.
Surgery is gold-standard for treatment of curvature in stable PD. Surgical therapy is subdivided into three main procedures: (1) plication techniques (Penile shortening procedures), (2) grafting procedures with partial plaque excision or incision followed by defect closure with various grafts, and (3) correction of deviation with simultaneous penile prosthesis implantation in patients with ED not responding to medical therapy.
In this study results of different surgical techniques in management of penile curvature will be compared.
Read the detailed description
The type of surgery will be chosen according to the degree of curvature and penile length after meticulous preoperative assessment.
Preoperative evaluation
- A thorough history will be taken, with special stress on:
- Sexual history, including concomitant ED and baseline erectile function as assessed using validated questionnaires such as the International Index of Erectile Function (IIEF).
- Penile curvature ;( direction, degree, interfere with intercourse (hand assisted or not), presence of pain, home (self) photograph during erection).
- Co-morbidities like vascular disease, diabetes mellitus, and cardiac disease.
- Special habits like tobacco use and drug intake.
- History of penile trauma.
- History of previous penile surgery.
- Physical examination including
- Measurement of stretched penile length, girth measurement, and penile sensation to touch.
- Direction and degree of penile curvature will be measured using the protractor through examination of the pharmacologically erect penis by office test using intracavernosal PGE1 (20 mg) and photograph taken during erection in the outpatient clinic.
- In cases of PD, the size, number, and position of the plaques will be assessed. • Routine evaluation for fitness before surgery. Operative techniques All surgeries will be performed under anaesthesia starting by a circumfericial degloving incision. After lateral dissection and mobilization of the neurovascular bundle, an artificial erection will be performed to assess the degree of deformity and the point of maximum curvature.
Plication On convex side of the shaft, Allis clamps are used on the greater curvature to estimate the number and length of tissue needed for plications, nonabsorbable stitches are placed into the tunica albuginea in pairs and adjusted as needed to achieve optimal straightening. The artificial erection is then released and sutures tied.
Nesbit Technique On the convex side of the shaft, excision of horizontal ellipses of the tunica albuginea on the greater curvature (with approximately 1 mm for each 10º of curvature), Allis clamps are then applied until the desired straightening is achieved. These ellipses are excised and closed transversely in a stepwise fashion until curvature is completely corrected.
Modified Nesbit Technique On the convex side of the shaft consisted of a longitudinal incision in the tunica with transverse closure (Heineke- Mikulicz principle), The length of the incision is limited to about 1 cm to prevent excessive indentation of the penis.
Length-Preserving Techniques (Grafting Technique) On the concave border of the penile shaft tunica lengthening procedures involve incising or excising the plaque, and adding graft material to cover the defect, Excision can be avoided if the surgeon is able to perform relaxing incisions on the plaque with added grafting material. The graft (usually 20% larger than the defect) is then sutured to the tunica albuginea with separate running suture, The types of graft used are autologous buccal mucosa or dermal graft.
The patients will return to outpatient clinic after discharge by 1 month and 3 months to evaluate for the postoperative results and complications.
Statistical analysis The statistical analysis will be done using SPSS 21.0 (statistical package for the social sciences).
Ethical considerations Informed written consent will be obtained from all patients after explanation of the operative details and possible postoperative complications.
- Conditions
- Complication of Surgical Procedure
- Keywords
- penile curvature, Peyronie's disease, Nesbit
- Medical subject headings
- Penile Induration
What is being measured
The primary outcome is the main question the study is designed to answer.
Correcting the curvature.
Measure of any residual curvature present by using the protractor.
Measured: 3 months postoperative
Preserving erectile function and hardness.
to show any affection of erectile function by using Interarnational index of Erectile dysfunction questionnaire.
Measured: 4 months
Preserving penile length.
to measure penile length postoperative and compare to the preoperative length
Measured: 3 months
Penile sensation.
To show any affection of penile sensation postoperative
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elgendy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313986
- Sponsor's protocol ID
- Adult penile curvature
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makovey I, Higuchi TT, Montague DK, Angermeier KW, Wood HM. Congenital penile curvature: update and management. Curr Urol Rep. 2012 Aug;13(4):290-7. doi: 10.1007/s11934-012-0257-x.
PubMed 22688922Devine CJ Jr, Horton CE. Chordee without hypospadias. J Urol. 1973 Aug;110(2):264-71. doi: 10.1016/s0022-5347(17)60183-6. No abstract available.
PubMed 4722625Kramer SA, Aydin G, Kelalis PP. Chordee without hypospadias in children. J Urol. 1982 Sep;128(3):559-61. doi: 10.1016/s0022-5347(17)53045-1.
PubMed 7120563Donnahoo KK, Cain MP, Pope JC, Casale AJ, Keating MA, Adams MC, Rink RC. Etiology, management and surgical complications of congenital chordee without hypospadias. J Urol. 1998 Sep;160(3 Pt 2):1120-2. doi: 10.1097/00005392-199809020-00041.
PubMed 9719289Bar Yosef Y, Binyamini J, Matzkin H, Ben-Chaim J. Midline dorsal plication technique for penile curvature repair. J Urol. 2004 Oct;172(4 Pt 1):1368-9. doi: 10.1097/01.ju.0000138341.68365.b6.
PubMed 15371846Nehra A, Alterowitz R, Culkin DJ, Faraday MM, Hakim LS, Heidelbaugh JJ, Khera M, Kirkby E, McVary KT, Miner MM, Nelson CJ, Sadeghi-Nejad H, Seftel AD, Shindel AW, Burnett AL; American Urological Association Education and Research, Inc.,. Peyronie's Disease: AUA Guideline. J Urol. 2015 Sep;194(3):745-53. doi: 10.1016/j.juro.2015.05.098. Epub 2015 Jun 9.
PubMed 26066402
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgical Correction of Penile Curvature in Adult
- ClinicalTrials.gov ID
- NCT03313986
- Acronym / sponsor ID
- Adult penile curvature
- Conditions
- Complication of Surgical Procedure
- Keywords
- penile curvature, Peyronie's disease, Nesbit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 19 Oct 2017 (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.
Penile curvature in adults is divided into two main categories the first is congenital penile curvature with orthotopic meatus and the other is acquired curvature which its common causes are Peyronie's disease (PD) and previous penile surgery as for hypospadias repair.The congenital penile curvatures (CPC) which not associated with urethral malformation is a relatively uncommon condition that may present in late adolescent or early adult life. The incidence is estimated to be 0.6 % but the incidence of clinically significant CPC is much lower, as the degree of curvature and sexual dysfunction varies widely Penile curvature may lead to inability for sexual intercourse. These cases require treatment. Acquired penile curvature its most common cause is Peyronie's disease. Peyronie's disease is a fibrotic disorder of the tunica albuginea of the corpora cavernosa that is clinically defined by the presence of a palpable, inelastic tunical plaque. PD is relatively common and affects up to 20.3% of adult men to some degree.
Surgery is gold-standard for treatment of curvature in stable PD. Surgical therapy is subdivided into three main procedures: (1) plication techniques (Penile shortening procedures), (2) grafting procedures with partial plaque excision or incision followed by defect closure with various grafts, and (3) correction of deviation with simultaneous penile prosthesis implantation in patients with ED not responding to medical therapy.
In this study results of different surgical techniques in management of penile curvature will be compared.
Detailed description
The type of surgery will be chosen according to the degree of curvature and penile length after meticulous preoperative assessment.
Preoperative evaluation
- A thorough history will be taken, with special stress on:
- Sexual history, including concomitant ED and baseline erectile function as assessed using validated questionnaires such as the International Index of Erectile Function (IIEF).
- Penile curvature ;( direction, degree, interfere with intercourse (hand assisted or not), presence of pain, home (self) photograph during erection).
- Co-morbidities like vascular disease, diabetes mellitus, and cardiac disease.
- Special habits like tobacco use and drug intake.
- History of penile trauma.
- History of previous penile surgery.
- Physical examination including
- Measurement of stretched penile length, girth measurement, and penile sensation to touch.
- Direction and degree of penile curvature will be measured using the protractor through examination of the pharmacologically erect penis by office test using intracavernosal PGE1 (20 mg) and photograph taken during erection in the outpatient clinic.
- In cases of PD, the size, number, and position of the plaques will be assessed. • Routine evaluation for fitness before surgery. Operative techniques All surgeries will be performed under anaesthesia starting by a circumfericial degloving incision. After lateral dissection and mobilization of the neurovascular bundle, an artificial erection will be performed to assess the degree of deformity and the point of maximum curvature.
Plication On convex side of the shaft, Allis clamps are used on the greater curvature to estimate the number and length of tissue needed for plications, nonabsorbable stitches are placed into the tunica albuginea in pairs and adjusted as needed to achieve optimal straightening. The artificial erection is then released and sutures tied.
Nesbit Technique On the convex side of the shaft, excision of horizontal ellipses of the tunica albuginea on the greater curvature (with approximately 1 mm for each 10º of curvature), Allis clamps are then applied until the desired straightening is achieved. These ellipses are excised and closed transversely in a stepwise fashion until curvature is completely corrected.
Modified Nesbit Technique On the convex side of the shaft consisted of a longitudinal incision in the tunica with transverse closure (Heineke- Mikulicz principle), The length of the incision is limited to about 1 cm to prevent excessive indentation of the penis.
Length-Preserving Techniques (Grafting Technique) On the concave border of the penile shaft tunica lengthening procedures involve incising or excising the plaque, and adding graft material to cover the defect, Excision can be avoided if the surgeon is able to perform relaxing incisions on the plaque with added grafting material. The graft (usually 20% larger than the defect) is then sutured to the tunica albuginea with separate running suture, The types of graft used are autologous buccal mucosa or dermal graft.
The patients will return to outpatient clinic after discharge by 1 month and 3 months to evaluate for the postoperative results and complications.
Statistical analysis The statistical analysis will be done using SPSS 21.0 (statistical package for the social sciences).
Ethical considerations Informed written consent will be obtained from all patients after explanation of the operative details and possible postoperative complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with penile curvature with failure of conservative/medical treatment (nonsurgical treatment) and patient's preference for definite results According to exclusion and inclusion criteria Attending Assiut andrology outpatient clinic.
Key inclusion criteria (1 listed)
- penile curvature more than 30degree.
Key exclusion criteria (3 listed)
- Age: less than 18 years.
- Non-orthotopic meatus
- Patients with ED.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correcting the curvature.
Time frame: 3 months postoperative
Measure of any residual curvature present by using the protractor.
Preserving erectile function and hardness.
Time frame: 4 months
to show any affection of erectile function by using Interarnational index of Erectile dysfunction questionnaire.
Preserving penile length.
Time frame: 3 months
to measure penile length postoperative and compare to the preoperative length
Penile sensation.
Time frame: 3 months
To show any affection of penile sensation postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Results publication: PubMed 22688922Makovey I, Higuchi TT, Montague DK, Angermeier KW, Wood HM. Congenital penile curvature: update and management. Curr Urol Rep. 2012 Aug;13(4):290-7. doi: 10.1007/s11934-012-0257-x.
- Results publication: PubMed 4722625Devine CJ Jr, Horton CE. Chordee without hypospadias. J Urol. 1973 Aug;110(2):264-71. doi: 10.1016/s0022-5347(17)60183-6. No abstract available.
- Results publication: PubMed 7120563Kramer SA, Aydin G, Kelalis PP. Chordee without hypospadias in children. J Urol. 1982 Sep;128(3):559-61. doi: 10.1016/s0022-5347(17)53045-1.
- Results publication: PubMed 9719289Donnahoo KK, Cain MP, Pope JC, Casale AJ, Keating MA, Adams MC, Rink RC. Etiology, management and surgical complications of congenital chordee without hypospadias. J Urol. 1998 Sep;160(3 Pt 2):1120-2. doi: 10.1097/00005392-199809020-00041.
- Results publication: PubMed 15371846Bar Yosef Y, Binyamini J, Matzkin H, Ben-Chaim J. Midline dorsal plication technique for penile curvature repair. J Urol. 2004 Oct;172(4 Pt 1):1368-9. doi: 10.1097/01.ju.0000138341.68365.b6.
- Results publication: PubMed 26066402Nehra A, Alterowitz R, Culkin DJ, Faraday MM, Hakim LS, Heidelbaugh JJ, Khera M, Kirkby E, McVary KT, Miner MM, Nelson CJ, Sadeghi-Nejad H, Seftel AD, Shindel AW, Burnett AL; American Urological Association Education and Research, Inc.,. Peyronie's Disease: AUA Guideline. J Urol. 2015 Sep;194(3):745-53. doi: 10.1016/j.juro.2015.05.098. Epub 2015 Jun 9.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Surgical Procedure, run by Assiut University.
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 3 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Mohamed Elgendy, master (01009882171, elgendy8686@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correcting the curvature. (time frame: 3 months postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03313986, which also lists 6 linked publications.
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 19 Oct 2017.