Hypothesis / aims of study
Autologous fascial slings (AFS) have increased in popularity in our tertiary referral unit since 2010. AFS were traditionally used to treat Stress Urinary Incontinence (SUI) for women with intrinsic sphincter deficiency (low mid-urethral closure pressures) or for secondary surgery in recurrent SUI. Given concerns about mesh related complications associated with mid-urethral tape procedures, increasing numbers of women are choosing AFS for both primary and secondary (recurrent SUI) surgical treatment for SUI.
Our aim was to assess the effect of low, borderline or normal maximum urethral closure pressure (MUCP) on the long-term success and complication rates of Autologous Fascial Slings (AFS) for SUI in clinical practice.
Study design, materials and methods
Retrospective analysis of data collected from the hospital database for AFS performed from 2010- 2017 was carried out. Patient electronic case notes were reviewed. All patients had a “sling-on-a-string”1 procedure, placed either mid-urethrally (non-obstructive) or at the bladder neck (obstructive). Women were categorized in 3 groups based on MUCP -having low (<30cm H2O), borderline (30-40cm H2O) or normal (>40cm H2O) MUCP. The primary outcome was patient reported improvement on a 4-point scale: ‘cured, improved, no change, worse’ as utilised on the British Society of Urogynaecologists audit database. Success was defined as patient-reported resolution of symptoms (cured) and significant improvement when women felt they had improved symptoms but were not symptom free.
Secondary outcome was to assess complications particularly voiding dysfunction, overactive bladder and need for further treatment.
Results
96 AFS procedures were identified by the database and electronic records were reviewed. All patients were more than 1 year post-operative and 23.9% (21) were more than 5 years post-operative.
MUCP was recorded for 89.8% (79/88) patients. 19.3% (17) of women had low MUCP, 17.7% (14) had borderline MUCP and 60.8% (48) had normal MUCP. In women with normal MUCP, 54% (26) were performed as primary procedures (all non-obstructive slings except one patient who specifically wished an obstructive sling) for SUI which accounts for a third of all the patients in our cohort who had AFS. 82.4% (14/17) patients with low MUCP and 57.1% (8/14) with borderline MUCP had AFS for secondary/recurrent SUI.
Outcomes:
Success: Table 1
Overall 72/79 patients (91.1%) were cured requiring no further treatment for SUI. Cure rates were the same at 5 years as at 1 year post-operative.
4/79 patients (5.1%), though not completely dry, reported significant improvement in their symptoms.. Two of these women opted for sling adjustment and two opted for bladder neck injections and all were subsequently cured of SUI.
In women with normal MUCP, those having AFS for primary SUI (26) had a slightly lower success rate - 84.6% (23) compared to those who had AFS as a secondary surgery (22) for SUI with a cure rate of 90% (19). Across all three groups, women who had obstructive AFS had higher success irrespective of whether they were performed for primary or recurrent SUI. All women who had obstructive AFS with low or borderline MUCP were cured (100 % successful).
Failure:
Only 3 patient were “no change”. 2 of these women and 2 women who experienced some improvement opted to have further surgical treatment. There were no reported cases of worsening SUI symptoms.
All sling failures occurred within the first year postoperatively.
• Low MUCP
The patient’s pelvis was noted to be extensively scarred from multiple previous vaginal surgeries and it was not possible to mobilise her urethra.
• Borderline MUCP
One patient had redo of AFS and was cured.
• Normal MUCP
Three women were not cured and required further treatment. One woman experienced no benefit immediately postoperative- the sutures were found to have pulled off the sling. She had redo of AFS and was cured. Two women opted for further tightening of the sling which was undertaken within a few weeks of initial surgery and were cured.
Complications:
Perioperative:
• 2 (2.5%) patients had bladder injury noted intraoperatively and all were successfully treated conservatively. There were no bowel injuries.
• 26.5% (21) required antibiotics for wound infection but only 5.1% (4) of women needed inpatient management.
Clean Intermittent Self Catheterisation (CISC)
Table 2
Post-operative voiding dysfunction requiring CISC was common with 59% women discharged from hospital performing CISC. The rate dropped at each follow-up point with the biggest fall was seen between 1 and 3 months. Most women who were still doing CISC at 6 months continued to do so long-term. As expected, obstructive procedures had a higher rate of ongoing CISC beyond 12 months, irrespective of MUCP (31.6% versus 11% with non-obstructive slings). Higher rates of CISC beyond 12 months post-operatively were seen in women with low (23.5%) or borderline (20%) MUCP because a higher proportion of women with low and borderline MUCP had obstructive procedures.
19 women had other risk factors for long-term CISC – 5 of them were performing CISC pre-operatively, a further 9 had pre-existing voiding dysfunction but were not catheterising. 2 additional women had pre-operative Botox injections and 5 commenced Botox post-operatively for new or worsening Over Active Bladder (OAB). 60 women had no additional risk factors for CISC and so had lower rates of CISC– 49 had non-obstructive procedures with 6/49 performing CISC at 3 months (12.3%) and 3/49 at 12 months (6.2%). 11 had obstructive procedures with 3 at 3 months (25%) and 1 at 12 (8.3%) months still performing CISC.
Worsening OAB:
21.1% (19) women experienced worsened or new onset OAB symptoms. Women with normal MUCP were less likely to experience an exacerbation of OAB symptoms 12.5% (6) than women with low- 47% (8)- or borderline -35.7% (5)-MUCP probably because less patients in the normal MUCP group had an obstructive sling.
Interpretation of results
Autologous fascial slings offer a good cure rate in all groups. Obstructive procedures provide the best cure rates as expected but with higher rates of long-term CISC. Proportionately more obstructive slings were performed for women with low or borderline MUCP which may contribute to the higher overall cure rate seen in these women compared to those with normal MUCP, where more patients had non obstructive slings.
Women with normal MUCP had a higher cure rate with non-obstructive AFS and lower rate of CISC. Long term rate of CISC in women with no pre-existing voiding dysfunction are low with both obstructive and non-obstructive slings.