Outcomes of Surgical Correction of Penile Curvature in Adult

October 14, 2017 updated by: Mohamed Elgendy, Assiut University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

Inclusion Criteria:

  • penile curvature more than 30degree.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correcting the curvature.
Time Frame: 3 months postoperative
Measure of any residual curvature present by using the protractor.
3 months postoperative
Preserving erectile function and hardness.
Time Frame: 4 months
to show any affection of erectile function by using Interarnational index of Erectile dysfunction questionnaire.
4 months
Preserving penile length.
Time Frame: 3 months
to measure penile length postoperative and compare to the preoperative length
3 months
Penile sensation.
Time Frame: 3 months
To show any affection of penile sensation postoperative
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 14, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 14, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Adult penile curvature

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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