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

NCT05764889 | Unknown

• 1 other identifier: M2022628
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circumcision, Male

Keywords

Circumcision; Postoperative complications; Protection devices

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Wound pain assessment

  through study completion, an average of 12weeks

• Comfort and convenience assessment

  through study completion, an average of 12weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

OTHER

Patients in the control group were wrapped with traditional gauze after operation.

Other: wrapped with traditional gauze

Interventions

wrapped with the Flexible Sleeve Penis Protection Device OTHER

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.

Experimental group

wrapped with traditional gauze OTHER

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.

Control group

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Liu Zhuo: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (4)

• 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.

  PMID: 31364098 BACKGROUND

• 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.

  PMID: 28265321 BACKGROUND

• 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.

  PMID: 32984117 BACKGROUND

• 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.

  PMID: 30270101 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhuo Liu, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Doctor

Model Details: Patients in the experimental group were wrapped with this device postoperatively Patients in the control group were wrapped with traditional gauze postoperatively.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 13, 2023
• Study Start: March 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)