Hypothesis / aims of study
Optilume drug-coated balloon is a novel treatment for anterior urethral strictures in men. The procedure is done under flexible cystoscopy guidance and involves a combination of balloon dilatation of the urethral stricture and treating the dilated area with paclitaxel, a microtubule inhibitor. It provides a simple and safe alternative to conventional urethral stricture treatments namely urethrotomy, rod dilation and open urethroplasty. Carrying out this procedure in outpatient with topical application of local anaesthetic provides significant medical, economical and logistical advantages at a time where our health system is under enormous pressure.
As the first centre in Europe to deliver Optilume treatment almost exclusively in an outpatient setting, we are interested in patients overall experience, throughout the peri-procedure period. We anticipated patients main concerns would be pain during balloon dilatation, anxiety in receiving a novel treatment without sedation and the lack of ward-based post-operative care in the immediate recovery period.
Study design, materials and methods
We have designed a patient experience questionnaire with information collected over the phone 7-14 days post-procedure. The questionnaire is divided in 3 sections: pre-procedure, during procedure and post-procedure, to gain feedback on the following the domains:
1. Patient experience receiving treatment in outpatient setting versus day surgery
2. Tolerability of procedure under local anaesthetic only and post-procedure pain
3. Recovery
4. Comparison to conventional treatments for urethral stricture
Results
Outpatient vs. Day Surgery: 100% of patients found it easier to arrange an outpatient appointment for Optilume treatment compared to arranging day case surgery in theatre. 90% of patients report they are less anxious receiving treatment in outpatient setting compared to a theatre procedure.
Tolerability: 70% of patients report experienced discomfort at one point of the procedure, 57% of which reported the most uncomfortable part being insertion of the flexible cystoscope, the remainder found balloon expansion being the most uncomfortable/painful. Patients were asked to rate pain experienced from 0 (no pain) to 10 (worst painful), mean pain score was 2.8 and 100% of patients agreed the procedure was tolerable with Instillagel given prior to the procedure. 20% of patients required simple analgesia post-procedure, the rest did not require any form of analgesia.
Recovery: Time between procedure and resuming their normal daily activities ranged from immediate to 5 days — 20% of patients reported returning to normal daily activities immediately, 50% within 24 hours as soon as after removal of catheter. All patients agreed there is improvement in urinary symptoms. Relief of urethral stricture symptoms by Optilume treatment is apparent immediately after procedure/on removal of urethral catheter in 80% of patients. All patients were satisfied with speed and ease of recovery.
Should urethral stricture symptoms recur, 90% of patients will opt to have Optilume in outpatient setting again, patients who did not prefer Optilume in outpatient preferred receiving treatment under general anesthesia. When given the option of Optilume to conventional urethral stricture treatments — 80% patients would have Optilume rather than Rod/S-curve dilator treatment under local anaesthetics, and 70% patients would have Optilume rather than urethroplasty, no patient preferred optical urethrotomy over Optilume.
Interpretation of results
1. Patients appreciated the ease and flexibility of booking the Optilume appointment in an outpatient setting as compared to the complex booking process for daycase or inpatient surgery. Anxiety from receiving a cystoscopic procedure without sedation and being able to see the entire procedure on screen was the main issue for one patient who prefer receiving treatment in theatre under general anaesthesia/sedation. Improvements in clinic set up (using screens, providing music or other distractions during the procedure) could enhance the patient experience and alleviate anxiety.
2. Most patients report minimal pain or less pain than anticipated. 2x 11ml cold Instillagel administered 10 minutes pre-procedure followed by a further 11ml of Instillagel provides adequate pain relief. Most patients described balloon expansion as 'discomfort' rather than pain.
3. None of the patients experienced pain more than 24 hours after procedure. Patients who experienced slight haematuria immediately following removal of the Optilume catheter are sent home with a Foley catheter to be left in in-situ for 24 hours.
4. Most of our patients had undergone a variety of other stricture treatments in the past. The majority of patients expressed a preference for the Optilume dilatation when presented with the choice of potential future procedures in the event of stricture recurrence.