ICS 2024 - Results of the use of the Harex® penis clamp

Hypothesis / aims of study

The Harex® penis clamp is effective in controlling post-prostate surgery urinary incontinence

Study design, materials and methods

Prospective clinical research with a low intervention level, in male patients over 18 years of age, with stress urinary incontinence after prostatic surgery, who are offered the use of the Harex® penis clamp as a treatment option. Patients who consent to enter the study are provided with the clamp free of charge, and are instructed in its use. These patients are evaluated 4 weeks after their use, obtaining:- The improvement in incontinence through the Treatment Benefit Scale (TBS) and ICIQ-SF questionnaire - Number of absorbents needed in 24h- Patient satisfaction in relation to the Harex® penis clamp (0-10)- Ease of use of the penis clamp (YES/NO)- Record of complications using the Clavien-Dindo classification.

Results

From November 2021 to February 2023, 26 patients have been entered into the study. The mean age was 68.7 years (6.2). The previous surgery was: open radical prostatectomy: 7 patients (26.9%), laparoscopic radical prostatectomy: 13 (50%), robotic radical prostatectomy 1 (3.8%), prostate TUR: 4 (15.4%), and 1 prostate photovaporization (3.8%). Eight patients had a history of radiotherapy (30.8%). Five patients had a history of previous anti-incontinence surgery (26.9%). Regarding the result of the ICIQ-SF questionnaire, the mean was 17 (4). The mean number of pads was 4.2 (2.1), and 2 patients used a collector. In relation to the urodynamic study, the mean maximum cystometric capacity was 287.6ml (111.9), and 10 patients presented detrusor overactivity. After using the clamp for one month, a follow-up telephone survey was conducted. The mean score of the ICIQ-SF questionnaire decreased to 12 (6) (p=0.000). In the TBS, 12 patients (46%) reported that they were better or slightly better, 9 shown no benefit, and 3 were worse (“my penis swells with urine and when I remove the clamp I get all wet” in 2 cases and discomfort in the penis in 1 case).Regarding the number of absorbents, it decreased to 2.9/day (1.9) (p= 0.005). The average satisfaction rate was 6/10. Nineteen patients (73%) reported ease of use of the device. In relation to complications, 4 patients presented mild penile pain and 1 hematoma in the area where the clamp was placed (Clavien-Dindo 1). Two patients explained persistence of urinary incontinence despite the correct use of the clamp. Accidental fall of the clamp was reported in 5 patients with retractile penis.

Interpretation of results

Urinary incontinence is a recognized complication after prostate surgery, significantly affecting the quality of life of patients (1). The penile clamp can be considered as a valid alternative to avoid or reduce the use of absorbents (2) as a temporary treatment or in non-surgical candidates. Despite its wide use in routine clinical practice, there is little evidence to support this type of device. This study has shown that patients who use the Harex® penis clamp have a significant reduction in the ICIQ-SF score, and in the number of pads used daily. The results should be interpreted taking into account that they used the clamp for a maximum of 8 hours, requiring absorbents or a collector while not using the clamp

Concluding message

The Harex® penis clamp is an effective and safe device for the conservative management of urinary incontinence after prostate surgery.

References

1.- Vera Trofimenko, Jeremy B Myers, William O Brant. Post-Prostatectomy Incontinence: How Common and Bothersome Is It Really? Sex Med Rev. 2017; 5(4): 536-5432.- Margaret Macaulay, Jackie Broadbridge, Heather Gage, Peter Williams, Brian Birch, Katherine N Moore, Alan Cottenden, Mandy J Fader. A trial of devices for urinary incontinence after treatment for prostate cancer. BJU Int. 2015; 116(3): 432-42