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Outcomes of Surgical Correction of Penile Curvature in Adult

This study is not yet open for participant recruitment.
Verified October 2017 by Mohamed Elgendy, Assiut University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03313986
First Posted: October 19, 2017
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohamed Elgendy, Assiut University
  Purpose

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.


Condition
Complication of Surgical Procedure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes of Surgical Correction of Penile Curvature in Adult

Further study details as provided by Mohamed Elgendy, Assiut University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50
Anticipated Study Start Date: November 1, 2017
Estimated Study Completion Date: December 1, 2020
Estimated Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • penile curvature more than 30degree.

Exclusion Criteria:

  • Age: less than 18 years.
  • Non-orthotopic meatus
  • Patients with ED.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313986


Contacts
Contact: Mohamed Elgendy, master 01009882171 elgendy8686@hotmail.com

Sponsors and Collaborators
Assiut University
  More Information

Publications:
Responsible Party: Mohamed Elgendy, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03313986     History of Changes
Other Study ID Numbers: Adult penile curvature
First Submitted: October 9, 2017
First Posted: October 19, 2017
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Elgendy, Assiut University:
penile curvature
Peyronie's disease
Nesbit