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Open Access Journal of Urology & Nephrology Research Article 12 min read

Nine Year Median Follow Up of Mid-Urethral Slings and Autologous Sling, Single Center Experience

Mohamed Elkhamesy, Ahmed A Selim and Bassem S Wadie*
* Corresponding author
ISSN: 2578-4676  10.23880/oajun-16000178  Received: April 08, 2020  Published: May 04, 2020
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Keywords
Sling MUS Long-term Outcome
Abstract

Objective: Evaluation of the subjective and objective cure rates as well as adverse events of 3 major procedures used for treatment of SUI. We also compared them in attempt to explore their long-term efficacy and safety Materials and Methods: All baseline demographic data as well as clinical data including stress and pad tests were collected. Urodynamics at baseline and at last follow up were reported together with UDSi-6 and IIQ-7 symptoms scores of all women included. SPSS was used for statistical analysis. Results: Study included 65 women; 32 underwent PVS while 19 TVT and 14 TOT with a mean age was 46.55 ± 7.07. All were followed to a minimum of 5 years (Median: 9 years). 39 had isolated stress incontinence while 26 had MUI. 30 had grade I POP and 5 patients had grade II POP. 40 women (61.5%) underwent sling only, while 38.5% underwent concomitant surgery for POP. At last follow up, 58 patients had no POP while 7 patients had. Stress test was negative in 55 patients while ten patients had positive stress test. Quality of life at last follow up showed no significant difference among treatment groups Conclusion: Synthetic MUS were comparable to PVS at long term follow up. All slings maintained a reasonable objective cure rate with time while no new adverse events develop after 5 years.

Introduction

MUS are the mainstay of surgical treatment of women with SUI. We first reported the comparative efficacy of TVT as compared to PVS in the first reported RCT on the subject [1]. Since then, tremendous amount of publications evolved on the long term efficacy of either PVS or synthetic MUS [2, 3]. Since 2011, after the FDA has issued it public notification on the use of mesh in correction of POP, a trend of decline in the use of mesh in correction of POP was first reported [4], then a decline in the use of synthetic MUS was also reported. Rac, et al. [5] have also noted that PVS have witnessed significant increase in its application when compared to total SUI intervention, from 21% of all SUI surgeries in 2007 to 30% in 2013 (P < 0.0001). MUS showed similar satisfactory result at medium and long term follow up. Objective cure rates were similar while TOT was associated with a lower subjective cure rate than TVT in a systematic review [6]. PVS was also attended with high cure rate. The cure/improved rate of PVS was 97% in 44 women with SUI at a median of 3 year follow up [7].

In this retrospective analysis, we evaluated women who underwent MUS or PVS over the past 14 years. We

examined the subjective and objective cure rates as well as adverse events developing during the observation period. We compared the 3 types of procedures to one another in attempt to explore their long-term efficacy and safety.

Patients and Methods

This is a retrospective study that included women who underwent mid-urethral sling (MUS) or PVS, during the period of 2001 to 2015 with a minimum follow up of five years. Patients were phone called and asked to attend an outpatient clinic visit. Informed consent was obtained from all patients before their enrollment. The study design and protocol were approved by local committee of the urology department at UNC.

Preoperative evaluation

We reviewed history, including gynecological and surgical past history. Patients were asked to fill in Arabic versions of IIQ-7, UDI-6 for evaluation of bothersome impact of stress incontinence in the last follow up visit. This questionnaire was introduced in Arabic validated form few years ago so preoperative results were not available for this analysis [8].

Physical examination

Patients underwent physical examination including stress test. The degree of pelvic organ prolapse (POP) was assessed and graded according to Baden and Walker [9]. Laboratory investigations included urine analysis with or without urine culture, serum creatinine, CBC and liver functions tests.

Urodynamic testing

Urodynamic testing was performed in all patients at baseline and 2 years afterwards. In those who experienced failure of the procedure and in patients in whom post voiding residual was more than 100 ml, urodynamics was requested at last follow up visit

Follow Up Schedule and Assessment of Outcome

Patients were assessed at the follow up visit, at which per vaginum examination, stress test, pad test, post-void residual urine (PVR) and symptom scores were recorded (a physician administered score) at this visit.

Stress Test

Stress test was performed by asking the patient to lie down, flexing her hips and thighs while the bladder is half- full and then to cough. A positive cough stress test, in which leakage is observed at the moment of the cough, is essential to confirm the diagnosis. One hour Pad test where the patient wears a pre-weighed pad, drinks 500 ml of water and rests for 15 minutes. She then performs 30 minutes of moderate exercise, such as stair climbing and walking. The remaining 15 minutes are spent performing more provocative exercises, including coughing vigorously, bending over, hand washing and running. At the end of one hour, the pad is removed and re-weighed. Increase in pad weight more than 2 grams is considered positive. This is not identical to the recommendation of the ICS, where an increase of 1.4 gm or more in 1-hour pad test was considered positive [10]. The explanation for this discrepancy arises from the fact that all our patients were obese, with 33.3 as an overall mean BMI. This together with more perspiration resulting from local hot climate would make 1.4 gm cut-off value rather unrealistic [11]. The primary outcome measure was correction of SUI as measured by stress test and pad test. Secondary outcome measures were evaluated using urogenital distress inventory (UDI-6), incontinence impact questionnaire (IIQ-7), as well as long term adverse events.

Results

Sixty five women were included, 32 patients underwent PVS while 19 patients had TVT and 14 TOT with a mean age was 46.55 ± 7.07. All were followed to a minimum of 5 years. Median follow up was 9 years (range 5-15).

PVS (n= 32)TVT (n=19)TOT (n=14)P value *
mean ± (SD)mean ± (SD)mean ± (SD)
Age46.50 ± (6.99)47.31±(6.82)45.64±(7.45)0.5557
Gravidity3.63±(1.66)3.17±(1.09)3.43±(1.34)0.556
Parity3.31±(1.34)3.17±(1.09)3.14±(1.16)0.874
BMI34.70±(10.47)31.80±(3.39)33.44 ±(4.76)0.674

Table 1: Demographic Data of Patients in the Study.

*P value is calculated using ANNOVA test. Table 1: Demographic Data of Patients in the Study.

Table 1 shows demographic data. Among our patients, 39 had isolated stress incontinence while 26 complained of mixed incontinence. Of the 65 patients, 31 patients were not complaining of POP, 30 had grade I POP and 5 patients had grade II POP. Ten patients (15.4%) had history of surgical correction of pelvic organ prolapse, 12 had other pelvic surgeries (18.5%) and 22 (33.8%) had irrelevant surgeries not related to the pelvis. Forty out of sixty five patients (61.5%) underwent sling only, while the remaining twenty five patients (38.5%) underwent concomitant surgery for POP. 19 underwent anterior colporrhaphy, 4 posterior colporrhaphy and 2 underwent combined anterior and posterior colporrhaphy. Table 2 shows the distribution of POP repair among study group. At last follow up visit, 58 patients were having normal local examination while 7 patients were complaining of prolapse (P= 0.88), 4 of them were de-novo, while 3 had previous concomitant anterior POP repair. Table 3 demonstrates the result of vaginal examination at last follow up (recall) visit.

POPSling type
PVSTVTTOTTotal
No.101383147.70%
grade I18452741.60%
grade II421710.70%
Total32191465100%

Table 2: Distribution of Anterior POP among Treatment Groups before Surgery.

Local ExaminationSling Type
PVSTVTTOTTotal
Normal2916125787.70%
Prolapse332811.30%
Total32191465100%

Table 3: Vaginal Examination Findings in Patients at Last Follow Up.

At last follow up, stress test was negative in 55 patients while ten patients had positive stress test. Difference between the three groups was insignificant regarding those with +ve stress test (p=0.8, using t test). Breaking up patients into 2 groups according to pad weight revealed that 48 patients had less than 2 Gm -increase (0 to less than 2) and 17 patients pad weight were more than 2 Gm. The difference between different types of MUS was not statistically significant (P=0.975), using ANOVA. Table 4 shows the distribution of stress test and positive pad test among treatment groups.

Table 5 shows urodynamic data of all patients at baseline. Two-year follow-up Urodynamic data is demonstrated in Table 6. No statistically significant difference between groups was noted. Quality of life at last follow up among treatment groups is displayed in Table 7. Fifty eight women had normal microscopic urine examination, while 8 patients had pus cell count more than 5/HPF. No long term adverse events were noticed from 5 years onwards, as reported by patients at last follow-up.

Stress testSling type
PVSTVTTOTTotal
-VE2716125584.60%
+VE5321015.40%
Total32191465100%
Pad test
Negative (< 2 gm)2414104873.80%
Positive (> 2 gm)8541726.20%
Total32191465100%
N:65PVS (n=32)TVT(n=19)TOT (n=14)
mean ± (SD)mean ± (SD)mean ± (SD)P Value*
PVR14.33± (22.2)52.42±(21.5)56.66±(49.0)0.553
Abd. LPP82.6±(28.04)80.6 ±(28.44)94.3± (29.7)0.878
Capacity396.44±(116.3)344.4±(123.7)408.5±(163.7)0.253
Qmax13.9 ±(7.4)17.7±(8.5)13.3±(6.4)0.953
Voided volume316.5± (75.9)247.0±(110.2)324.1±(144)0.331
P det Q max20.1±11.429.9±24.127.66±17.60.406

Table 4: Stress and Pad tests of Patients at Last Follow Up.

*P value is calculated using ANOVA test. Table 5: Urodynamic Variables at Baseline.

N= 60PVSTVTTOT
mean ± (SD)mean ± (SD)mean ± (SD)P Value *
PVR15.0±(7.9)17.7±(5.58)11.1±(4.77)0.35
Capacity337.6(102.5)340.44 (116.8)375.15±(78)0.331
Qmax18.5±(8.35)18±(11.82)18.6 ±(7017)0.652
Voided volume221.6±(93.63)220.7±(95.41)298±(95.64)0.876
P det Q max22.8±(6.7)19.2±(8.2)17±(7.2)0.08

Table 5: Urodynamic Variables at Interim Follow-Up.

*Significance testing using ANOVA. Table 6: Urodynamic Variables at Interim Follow-Up.

PVSTVTTOT
mean ± (SD)mean ± (SD)mean ± (SD)P Value*
UDI-644.9± (15)37.8 ±(13)43.9 ± (14)0.294
IIQ-742.9 ±(18)33.5±(15)37.6±(18)0.157

Table 6: Quality of Life among Patients at Last Follow- Up.

*P value was calculated using ANOVA. Table 7: Quality of Life among Patients at Last Follow- Up.

Discussion

Approximately 200,000 SUI surgeries are performed annually in the United States, increasing by 27% from 2000 to 2009. Most of this increase is attributed to sling procedures [12]. Mean age of our patients was 46.55 years. Our patients seem to be younger than those reported by Schauer, et al. [2] where they presented 10-year follow up of 139 patients with a mean age of 63 years. Similarly, a large Danish study involving 8671 patients found that mean age was 56.1 years [13]. They were studying the re-operation rate at 5-year where the cumulative incidence of reoperation after any surgical treatment for urinary incontinence was 10%. The lowest rate of reoperation was observed among women having pubovaginal slings (6%), retropubic midurethral tape (6%) and Burch colposuspension (6%) followed by transobturator tape (9%). In a Cox proportional hazard model, the transobturator tape carried a 2-fold higher risk of reoperation (HR, 2.1; 95% CI, 1.5-2.9). In our cohort, 52.3% had POP, ranging from grade 1 to 3 and some had anterior POP (18 cases) while 7 had posterior prolapse. The prevalence of urinary incontinence varies from 17-45% among adult women [14]. Similarly, 50% of parous women have POP [15]. The prevalence of POP among women with SUI is somewhere between 40% to 53.4% [16, 17]. Twenty five of our patients underwent concomitant correction of POP. The association of TVT-O with other procedures was studied by Cho MK, et al. [18] on 272 women having either TVT-O only (122 patients) or TVT-O and other procedure (150). The success rate was 89.3% in the TVT-O-only group vs. 93.3% in the TVT-O with concomitant gynecological surgery group (p =0.729).

Incontinence recurs in 8% of women after 10-year follow up of TVT-O according to Serati, et al. [19]. In TOMUS trial [20], 1- year objective failure rates of 19.2% and 22.3% were reported for retropubic and transobturator MUS respectively. Objective success was defined as negative stress test, 24-hour pad test and no re-treatment for stress- type incontinence. Based on stress test, overall success rate was 84.6%, while it was 73.8% based on 1 hour pad test. Price and Noblett [21] found that cough stress test is more reliable than the pad test for documentation of stress urinary incontinence. They founded their conclusion on the agreement between urodynamic testing and each of stress test and 24-hour pad test. Stress test showed 89% agreement while pad test exhibited only 60%. Three types of sling in our study did not show significant differences regarding success rate or HRQOL. Differences between the groups regarding PVR, bladder capacity, maximum flow rate and detrusor pressure at maximum flow as well as UDI and IIQ scores were statistically insignificant. However, detrusor pressure at maximum flow tended to be higher than both TVT and TOT (22.8 vs. 19.2 and 17cm H2O respectively). The difference did not amount to significance (p= 0.08). Success rates at median follow up were comparable. Based on stress test, 84.4%, 84.2% and 85.7% success rates were noted for PVS, TVT and TOT respectively. Based on pad test, rates were lower at 75%, 73.7% and 73.8% respectively. Jeon, et al. [22] have reported cure rates for the 3 types of sling in women with ISD with significantly poorer outcome regarding TOT (87.25%, 86.94%, and 34.89%, respectively; P < .0001) However, more recently, Ulrich, et al. [23] have published on 10-year of follow up of 112 women with TOT. They reported subjective and objective cure rates at 10 –year to be 69% and 64% respectively. We attempted to elucidate predictors of success among our patients. Univariate analysis was performed involving BMI, parity, abd. LPP, the presence of DO, sling type and the presence of concomitant surgery (Table 8). None of these variables proved significantly affecting the outcome. In one large volume study based of SISTER, Richter, et al. [24] found that only greater baseline urge incontinence symptoms, more advanced prolapse, and menopausal not on hormone replacement therapy are the only failure risk factors in women who underwent Burch or PVS alike. Our sample size was a significant shortcoming that would hinder conducting such analysis.

SuccessFailureP value
BMI <3063.20%36.80%0.39*
>3073.90%26.10%
Parity (1-7)70.80%29.20%0.71*
Abd. LPP (30-158cm H O)
2		70.30%29.70%0.52*
Detrusor Overactivity
Present57.10%42.90%0.34**
Absent72%28%
Sling Type
PVS71.90%28.10%0.82*
TVT73.70%26.30%
TOT64.30%35.70%
Concomitant surgery ϕ
No70%30%033*
Yes Anterior
Posterior
Combined		70%
100%
0%		30%
100%
0%

Table 7: Univariate Analysis to Assess Predictor of Success.

*Using Pearson Chi-square Using Fisher’s exact test Φ Surgery for POP Table 8:** Univariate Analysis to Assess Predictor of Success.

Our study is long term and involved a comprehensive array of subjective and objective outcome measures that give a reasonable insight for the long term outcome of most commonly used types of MUS. Sample size and incomplete urodynamic data are notable deficiency.

References

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@article{mohamed2020,
  title   = {Nine Year Median Follow Up of Mid-Urethral Slings and Autologous Sling, Single Center Experience},
  author  = {Mohamed Elkhamesy, Ahmed A Selim and Bassem S Wadie},
  journal = {Open Access Journal of Urology & Nephrology},
  year    = {2020},
  volume  = {5},
  number  = {2},
  doi     = {10.23880/oajun-16000178}
}
Mohamed Elkhamesy, Ahmed A Selim and Bassem S Wadie (2020). Nine Year Median Follow Up of Mid-Urethral Slings and Autologous Sling, Single Center Experience. Open Access Journal of Urology & Nephrology, 5(2). https://doi.org/10.23880/oajun-16000178
TY  - JOUR
TI  - Nine Year Median Follow Up of Mid-Urethral Slings and Autologous Sling, Single Center Experience
AU  - Mohamed Elkhamesy, Ahmed A Selim and Bassem S Wadie
JO  - Open Access Journal of Urology & Nephrology
PY  - 2020
VL  - 5
IS  - 2
DO  - 10.23880/oajun-16000178
ER  -