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

Circumcision, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05764889
• Other study ID #: M2022628
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: March 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Circumcision, Male

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Liu Zhuo

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative complication	Assessing the incidence of post-operative complications	through study completion, an average of 12weeks
Primary	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
Primary	Healing time	Time for sutures to come off completely and time for wound healing	through study completion, an average of 12weeks
Secondary	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
Secondary	Comfort and convenience assessment	Comfort and convenience assessed by questionnaire	through study completion, an average of 12weeks