Study on the Protective Effect of a Flexible Sleeve Penis Protection Device on Penis After Circumcision

Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. For post-circumcision patients, a flexible sleeve penile protection device was invented as a modification of the traditional gauze bandage. This study investigated the protective effect of the device by recruiting post-circumcision patients to use the device and collecting indicators related to post-operative recovery and patients' experience of using the device.

Study Overview

• Status: Enrolling by invitation
• Conditions: Circumcision, Male
• Intervention / Treatment: Other: wrapped with the Flexible Sleeve Penis Protection Device; Other: wrapped with traditional gauze

Detailed Description

Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. Post-circumcision patients remain at risk of gauze detachment, wound pain and post-operative bleeding, leading to serious post-operative adverse effects, including complications such as dehiscence and infection. The investigators have invented a flexible sleeve penile protection device, which consists of two components, a flexible sleeve and a hood, the main function of the flexible sleeve is to stop bleeding with compression and immobilisation, and the main function of the hood is to provide protection to the head of the penis and prevent the wound from rubbing against clothing leading to pain.

The aim of this study was to investigate the protective effect of a flexible sleeve penile protection device on post-circumcision patients in terms of gauze loosening and dislodging, post-operative pain and post-operative bleeding. This study was a prospective randomized controlled trial of patients who underwent circumcision at Peking University Third Hospital from February 2023 to May 2023. Patients in the experimental group were wrapped with this device postoperatively, while patients in the control group were wrapped with traditional gauze postoperatively. Patients were followed up regularly after surgery, and indicators such as complications, pain and recovery time were collected to investigate the protective effect of this device.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Diagnosed redundant prepuce and circumcised at Peking University Third Hospital.
2. Male patients aged between 12 and 60 years (inclusive).
3. The person or guardian fully understands and signs the informed consent form.

Exclusion Criteria:

1. Acute urinary and genital infections, such as acute urethritis, acute prostatitis, acute epididymitis, etc., or trauma.
2. Abnormal blood clotting function.
3. Those who are allergic to the materials used in the manufacture of the product.
4. Patients who are mentally incapable or unable to understand the requirements for participation in the study and have difficulty in cooperating.
5. Subjects who, in the opinion of the investigator, are unable to comply with follow-up, compromising the scientific validity and integrity of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively.	Other: wrapped with the Flexible Sleeve Penis Protection Device; Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. Patients in the control group were wrapped with traditional gauze post-operatively.
Other: Control group; Patients in the control group were wrapped with traditional gauze after operation.	Other: wrapped with traditional gauze; Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. Patients in the control group were wrapped with traditional gauze post-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative complication	Assessing the incidence of post-operative complications	through study completion, an average of 12weeks
Foreskin edema score	Assessment of foreskin oedema which includes 0-6 points. A higher score means a more severe case of penile foreskin oedema	through study completion, an average of 12weeks
Healing time	Time for sutures to come off completely and time for wound healing	through study completion, an average of 12weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound pain assessment	Using the Visual analogue scale ，which includes 0-10 points. A higher score means more pain	through study completion, an average of 12weeks
Comfort and convenience assessment	Comfort and convenience assessed by questionnaire	through study completion, an average of 12weeks

Collaborators and Investigators

• Sponsor: Liu Zhuo
• Investigators: Study Director: Zhuo Liu, MD, Peking University Third Hospital

Publications and helpful links

General Publications

• Soltany S, Ardestanizadeh A. The study of the factors affecting the time of ring fall off in circumcision using Plastibell. J Family Med Prim Care. 2020 Jun 30;9(6):2736-2740. doi: 10.4103/jfmpc.jfmpc_1261_19. eCollection 2020 Jun.
• Mu J, Fan L, Liu D, Zhu D. A Comparative Study on the Efficacy of Four Types of Circumcision for Elderly Males with Redundant Prepuce. Urol J. 2020 May 16;17(3):301-305. doi: 10.22037/uj.v0i0.4973.
• Abara EO. Prepuce health and childhood circumcision: Choices in Canada. Can Urol Assoc J. 2017 Jan-Feb;11(1-2Suppl1):S55-S62. doi: 10.5489/cuaj.4447.
• van den Dungen IAL, Rynja SP, Bosch JLHR, de Jong TPVM, de Kort LMO. Comparison of preputioplasty and circumcision in distal hypospadias correction: long-term follow-up. J Pediatr Urol. 2019 Feb;15(1):47.e1-47.e9. doi: 10.1016/j.jpurol.2018.08.001. Epub 2018 Aug 20.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative complications; Circumcision; Protection devices
• Other Study ID Numbers: M2022628

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