A study comparing two circumcision techniques in adult men with phimosis: effects on surgery time, penis length, sexual function, and sensitivity
| ISRCTN | ISRCTN10105871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10105871 |
| Sponsors | Gdańsk Medical University, University Clinical Centre, Gdańsk |
| Funder | Gdański Uniwersytet Medyczny |
- Submission date
- 03/04/2026
- Registration date
- 08/04/2026
- Last edited
- 08/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Phimosis is a condition where the foreskin is too tight to be pulled back over the head of the penis. It can cause pain, infections, problems with urination, and difficulties during sexual activity. Circumcision, which is the surgical removal of the foreskin, is the standard treatment for this condition. Circumcision can be performed using different techniques. The traditional method is done by the surgeon using standard surgical tools. A newer method uses a special disposable device that allows the procedure to be performed more quickly and in a more uniform way. Previous studies suggest that device-assisted circumcision may take less time and cause less bleeding during surgery. However, it is still unclear whether it affects recovery, sexual function, or sensitivity differently compared to the traditional method. The aim of this study is to compare these two circumcision techniques in adult men with phimosis. We will look at how long the procedure takes and how it affects penis length, sexual function, sensitivity, and overall patient experience.
Who can participate?
Adult men over the age of 18 who were diagnosed with phimosis and required circumcision as part of their treatment
What does the study involve?
Participants will be randomly assigned to one of two types of circumcision. This means that each person has an equal chance of receiving either the traditional surgical method or the device-assisted method. All procedures will be carried out under local anaesthesia (numbing medication), so patients will be awake but should not feel pain during the surgery. The procedure is performed as a day case, which means patients can go home the same day. After the surgery, they will receive clear instructions on how to care for the wound, including hygiene, dressing changes, and when it is safe to return to normal activities. Before the procedure, participants will be asked to complete simple questionnaires about their symptoms, sexual function, and how they feel about the appearance of their genitals. Doctors will also take measurements of penis length and assess sensitivity using a standard medical device. The total time of the procedure will be recorded, as this is one of the main outcomes of the study. Pain during and after the procedure will also be assessed using a simple rating scale. After the surgery, participants will return for follow-up visits. The first visit will take place at around 4 weeks, when doctors will check wound healing, remove any remaining stitches or staples if needed, and assess recovery. A final follow-up will take place at around 3 months after the procedure. At that time, participants will again complete questionnaires, and repeat measurements of penis length and sensitivity will be performed. Throughout the study, doctors will monitor for any complications or side effects to ensure patient safety.
What are the possible benefits and risks of participating?
There were no direct benefits associated with participating in the study. However, the benefits of participating in the study included the results of the circumcision procedure. It appears that the results of this study may influence patients' future decisions regarding their choice of circumcision method. The risks associated with participation in the study included typical post-circumcision complications, such as bleeding, surgical site infection, and wound dehiscence.
Where is the study run from?
Medical University of Gdańsk (Poland)
When is the study starting and how long is it expected to run for?
March 2024 to December 2024
Who is funding the study?
Medical University of Gdańsk (Poland)
Who is the main contact?
Jakub Gondek, kba@gumed.edu.pl
Contact information
Public, Scientific, Principal investigator
Medical University of Gdańsk, Smoluchowskiego 17
Gdańsk
80-214
Poland
 ORCID ID |
0009-0000-4010-8030 |
|---|---|
| Phone | +48 (0)58 349 31 60 |
| kba@gumed.edu.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Device feasibility, Treatment |
| Scientific title | A comparison between forceps-guided and stapler-assisted circumcision in adult phimosis: procedure time and 3-month changes in penile length, sexual function and vibratory sensitivity - a randomised trial |
| Study objectives | The CircC device is a disposable circular stapling and cutting system that enables rapid sleeve-type circumcision with simultaneous tissue excision and staple-line closure. Forceps-guided circumcision (FGC) is a conventional, widely taught open technique that remains routinely used in many centres. The present trial was designed to compare these two operative approaches in adult men with pathological phimosis under standardised single-surgeon conditions. |
| Ethics approval(s) |
Approved 01/03/2024, Bioethics Committee for Scientific Research, Medical University of Gdańsk (Dębinki 7, Gdańsk, 80-211, Poland; +48 (0)58 349 10 11; komisja.bioetyczna@gumed.edu.pl), ref: KB/87/2024 |
| Health condition(s) or problem(s) studied | Phimosis |
| Intervention | Patients were recruited consecutively and randomized in a 1:1 ratio using the National Cancer Institute Clinical Trial Randomization Tool - MTI method: maximal (National Cancer Institute. Clinical Trial Randomization Tool. https://ctrandomization.cancer.gov [accessed 18 March 2024]). The allocation sequence was generated in advance and stored in a secure, password-protected format accessible only to a study team member not involved in the eligibility assessment or surgery. Treatment assignment was obtained sequentially only after eligibility confirmation and the completion of baseline assessments. Circumcisions were performed under local anaesthesia using 10 ml of lidocaine 2% and 10 ml of bupivacaine 0.5%, administered circumferentially at the base of the penis. CircC technique: The device size was selected individually based on the penile circumference measured with the manufacturer-provided tape to ensure an appropriate fit of the glans-protective bell and stapling ring. Following frenuloplasty, a glans-protective bell was inserted beneath the foreskin. In instances where the preputial opening was constricted, a dorsal incision was made to facilitate insertion. Once the bell was positioned, the CircCurer™ device was applied and activated, simultaneously cutting and inserting the metal staples. Haemostasis was verified, and a pressure dressing was applied to manage the bleeding. FGC technique: Following frenuloplasty, the foreskin was grasped with two forceps to standardise traction, and a third transverse forceps was used as the cutting guide. The prepuce was excised distal to the clamp using a scalpel, haemostasis was obtained with bipolar cautery, and the skin edges were approximated with interrupted rapidly absorbable sutures, consistent with standard forceps-guided descriptions. Postoperatively, all patients were observed for several hours and discharged on the same day with instructions on penile elevation, twice-daily dressing changes, wound disinfection with antiseptic agents, and topical fusidic acid application for 14 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/12/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Male |
| Target sample size at registration | 100 |
| Total final enrolment | 81 |
| Key inclusion criteria | 1. Male sex 2. Age ≥18 years 3. Clinical diagnosis of pathological phimosis requiring circumcision 4. Ability to provide written informed consent 5. Willingness to complete the planned follow-up visits |
| Key exclusion criteria | 1. Active genital infection or balanoposthitis at the time of surgery 2. Suspected penile malignancy requiring broader oncological management 3. Known allergy to local anaesthetic 4. Contraindication to local anaesthetic |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 02/09/2024 |
Locations
Countries of recruitment
- Poland
Study participating centre
Gdańsk
80-952
Poland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 07/04/2026 | No | No | ||
| Protocol file | 07/04/2026 | No | No |
Additional files
- 49320_PROTOCOL.pdf
- Protocol file
- 49320_ConsentForm.pdf
- Other files
Editorial Notes
08/04/2026: Study's existence confirmed by the Bioethics Committee for Scientific Research, Medical University of Gdańsk.
