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Status unknownNCT03313986Updated Oct 19, 2017

Outcomes of Surgical Correction of Penile Curvature in Adult

An observational study in Complication of Surgical Procedure, sponsored by Assiut University. Status unknown. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-19.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
Male
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Study 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.

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.

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Conditions studied

  • Complication of Surgical Procedure

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Keywords

  • penile curvature
  • Peyronie's disease
  • Nesbit
03

In context

Penile Induration

47 studies on the registry are indexed under Penile Induration; 10 are open to participants now.

Browse Penile Induration studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • penile curvature more than 30degree.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Correcting the curvature.

    Measure of any residual curvature present by using the protractor.

    Time frame: 3 months postoperative

  2. Preserving erectile function and hardness.

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

    Time frame: 4 months

  3. Preserving penile length.

    to measure penile length postoperative and compare to the preoperative length

    Time frame: 3 months

  4. Penile sensation.

    To show any affection of penile sensation postoperative

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

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References and documents

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 22688922 ↗
  • 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. PubMed 4722625 ↗
  • 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. PubMed 7120563 ↗
  • 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. PubMed 9719289 ↗
  • 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. PubMed 15371846 ↗
  • 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. PubMed 26066402 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03313986
Lead sponsor
Assiut University
Responsible party
Mohamed Elgendy (Principal Investigator, Assiut University) — Principal investigator
First posted
Oct 19, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Nov 1, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Oct 19, 2017

Study contacts

Mohamed Elgendy, master
Contact
elgendy8686@hotmail.com
01009882171

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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