Outcomes of Surgical Correction of Penile Curvature in Adult
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Preserving erectile function and hardness.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •penile curvature more than 30degree.
排除标准
- •Age: less than 18 years.
- •Non-orthotopic meatus
- •Patients with ED.
结局指标
主要结局
Preserving erectile function and hardness.
时间窗: 4 months
to show any affection of erectile function by using Interarnational index of Erectile dysfunction questionnaire.
Preserving penile length.
时间窗: 3 months
to measure penile length postoperative and compare to the preoperative length
Penile sensation.
时间窗: 3 months
To show any affection of penile sensation postoperative
Correcting the curvature.
时间窗: 3 months postoperative
Measure of any residual curvature present by using the protractor.
次要结局
未报告次要终点
研究者
Mohamed Elgendy
Principal Investigator
Assiut University