One year follow up after operating with the Ophira Mini Sling System (Promedon) for urinary stress incontinence.

Larsson P1, Rajpar G1

Research Type


Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 762
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Incontinence Stress Urinary Incontinence Surgery Female
1.Skaraborg hospital


Hypothesis / aims of study
The outcome of operating using mini-slings for Stress Urinary Incontinence (SUI) has not been promising. We report encouraging results from one centre using a novel technique in an outpatient setting under local anaesthetic, and compare this with the National Registry for Incontinence procedures.
Study design, materials and methods
This prospective consecutive cohort study evaluated the outcome of operating using the Ophira® Mini Sling System from Promedon. A small 1.5cm incision is made in the anterior vaginal wall followed by periurethral dissection. The needle is inserted toward the obturator foramen and retracted to deploy the Sling Tip. The second Sling Tip is inserted into the contralateral side towards the obturator foramen. The needle is then advanced until appropriate Sling tension is achieved under local anaesthesia. As the patient is awaked she can be asked to cough. Operate with the Ophira mini-sling system using this technique began in 2017. Uniquely this procedure is carried out at our out-patient clinic, without support from an operating theatre or anaesthetic nurses. As the patients are first in the morning and without sedation, there are no challenges with voiding after the surgery. After voiding a bladder scan is carried out to ensure that they have emptied the bladder. 

All women operated on receive a questionnaire after eight weeks and one year. The same questionnaire is used nationally for other incontinence procedures. It is therefore possible to compare the results from our unit with other incontinence procedures carried out nationally, such as Tension Vaginal Tape (TVT-retropubic, TVT-Obtorator inside-out and TOT outside-in). The questionnaire states;
A. Do you have incontinence? Never, never, 1-3 time a months, 1-3 time a week, daily.  
B. Do you have over active bladder? Never, almost never, 1-3 time a months, 1-3 times a week, daily. C. Postoperatively do you feel, Much better, better, the same, worse or much worse. 
D. Are you satisfied of the postoperative results. Very satisfied, satisfied, the same, worse, much worse.
Since 2017 we have operated on a total of 109 women with SUI or Mixed Incontinence. Women have been selected consecutively with selections criteria of not been operated before. Women operated on during the second half of 2018 have not yet answered the 1 year follow-up questions. We therefore have responses from 91 women.  

The postoperative follow up after 1 year showed 59% (54/91) had no incontinence episodes and 18% (16/91) less than 1-3 times per month. 66% (59/90) had no over active bladder and 82% (75/91) were very satisfied or satisfied of the operating results and 11% were disappointed. 88% (80/91) of patients reported feeling better, 8% the same, and 3% of patients felt worse.  

From the National Incontinence Registry 3347 women have answered the same questionnaire. The operations were 57.0% TVT-retropubic, TVT-O 18.4% and TOT 21.9% and mini-slings 2.7%. 

In comparison the results show that 72% (2399/3345) had no incontinence episodes and 10% have leakage 1-3 times per month. 65% (2159/3341) had no over active bladder and 85% (2822/3328) were satisfied and 7% not satisfied. 90% (3011/3330) of patients reported feeling better, 6% the same and 12% worse.  

No peri-operative or post-operative complications have been observed, except 3 Urinary Tract Infections.
Interpretation of results
The results from operating with the Ophira mini-sling ® at our centre, demonstrates good outcomes similar to other procedures currently being used nationally. Considering the operation is in an out-patient clinic without an anesthetic nurse makes the operation much cheaper, less time-consuming and more convenient for our patients. Furthermore it has a faster recovery.
Concluding message
Using our novel method the Ophira® has demonstrated similar results to other TVT procedures currently practiced for treatment of SUI. The Ophira® is more simple, easier to perform than traditional TVT procedures and can be carried out in outpatient clinics without anaesthetic nurses.
Figure 1 Are you satisfied
Figure 2
<span class="text-strong">Funding</span> Have received financial support to travel to Rom, Italy to study the operation by Promedon. No other foundings or grants. <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Public Registry</span> No <span class="text-strong">RCT</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics not Req'd</span> clinical control study <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes