NCT03313986

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

October 9, 2017

Last Update Submit

October 14, 2017

Conditions

Keywords

penile curvaturePeyronie's diseaseNesbit

Outcome Measures

Primary Outcomes (4)

  • Correcting the curvature.

    Measure of any residual curvature present by using the protractor.

    3 months postoperative

  • Preserving erectile function and hardness.

    to show any affection of erectile function by using Interarnational index of Erectile dysfunction questionnaire.

    4 months

  • Preserving penile length.

    to measure penile length postoperative and compare to the preoperative length

    3 months

  • Penile sensation.

    To show any affection of penile sensation postoperative

    3 months

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • penile curvature more than 30degree.

You may not qualify if:

  • Age: less than 18 years.
  • Non-orthotopic meatus
  • Patients with ED.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

  • Devine 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.

  • Kramer 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.

  • Donnahoo 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.

  • Bar 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.

  • Nehra 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.

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Mohamed Elgendy, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 19, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share