Hybrid tape versus synthetic tape in treatment of female stress urinary incontinence .A prospective clinical study

doi:10.21203/rs.3.rs-2958083/v1

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Hybrid tape versus synthetic tape in treatment of female stress urinary incontinence .A prospective clinical study

https://doi.org/10.21203/rs.3.rs-2958083/v1

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Objective:

To compare the clinical and operative outcomes of hybrid tape versus synthetic tapes during mid-urethral sling in treating female stress urinary incontinence (SUI).

Patients and methods:

This prospective study included 60 women with SUI. Patients were categorized into two groups: Group I included 30 patients who underwent midurethral sling procedure using hybrid tape; and Group II included 30 patients that had synthetic sling, using trans obturator tape approach (TOT) in both groups . The following variables were compared: operative time, post operative pain scores, duration of indwelling urethral catheter, hospital stay, and QoL assessment (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF]) before and after discharge from hospital.

Results:

Patients among the two groups were normally distributed with no statistically significant difference in patient’s demographic data and comorbidities. There was an obvious increase in operative time in group I compared to group II. This increase was statistically highly significant. (p <0.001).

Conclusion:

Hybrid tape should be considered as a treatment option during TOT for female SUI with comparable efficacy and safety to synthetic tape. Long term follow up should be considered.

Subject classification codes: include these here if the journal requires them

female incontinence

synthetic mesh

rectus fascia

autologous graft

cough stress test

Vaginal and urethral sling erosions are complications unique to synthetic slings. Hybrid tape is a new technique supposed to avoid the complications of synthetic slings. It is composed of central autologous part which is taken from rectus fascia fixed to two lateral arms of the synthetic mesh

Take home messages:

It had a comparable efficacy and safety as synthetic sling during TOT for treatment of female SUI with lesser incidence of sling erosion.

Stress urinary incontinence (SUI) is one of the distressing problems that affects large numbers of women allover the world. It affects about 35% of women in the general population (1). The tension-free vaginal tape (TVT) has been established as main surgical approach for the treatment of SUI Since it was introduced by Ulmsten et al. in 1996. Despite TVT procedure was shown to have a high cure rate in the medium and long terms (2), complications such as bladder injury and retropubic hematoma resulting from the passage of the sling through the retropubic space and voiding dysfunction have been reported (3). Despite the popularity of the tension-free vaginal tape procedure via a retropubic approach, using an elastic polypropylene tape for the management of SUI, the overall safety of the synthetic slings have been put under further scrutiny due to the high complication rate weighted against its high long-term success rate [4]. The use of the transobturator route (outside–in) was advocated by Delorme et al. to avoid the complications associated with the retropubic route. (5)

Vaginal and urethral sling erosions are complications unique to synthetic slings (6). Hybrid tape is a new technique supposed to avoid the complications of synthetic slings. It is composed of central autologous part which is taken from rectus fascia fixed to two lateral arms of the synthetic mesh. This tape will be inserted under the mid urethra by TOT approach .the two lateral arms will give the advantage of self-fixation of the synthetic one. In this study we compared both the hybrid tape and the synthetic one as amid urethral sling in treatment of female SUI through TOT procedure.

This prospective study was conducted in October 2018 to October 2022. The study was approved by the faculty ethics committee [IRB approval code 5786-11-12-2019] and all patients signed an informed consent for the details of the procedure. Sample size was calculated assuming that mean ± SD for incontinence impact in autologous group versus synthetic group was 43.3 ± 47.3 VS 73.3 ± 38.8, the sample size was calculated to be 60 (30 in each group ) with confidence interval 95% & power of the test 85% using open EPI. Outcome measures: cure was defined as no leakage based on both symptom scale scoring and physical examination. improvement was defined as ≥ 50% decrease in symptoms based on the questionnaire‘s results.

We included all the patients with pure stress urinary incontinence scheduled for TOT as defined by the symptom of involuntary urine leakage on any increase of intra-abdominal pressure (e.g. coughing, exertion, etc.) and confirmed objectively by clinical evaluation. We excluded patients with detrusor overactivity and/or detrusor overactivity UI as confirmed by urodynamics. Patients who had significant pelvic organ prolapse that required surgical correction or had a history of previous prolapse repair, or active UTI, or having evidence of voiding dysfunction and patients with a PVR > 100 mL by urodynamics, were excluded from enrolment into the study.

Patients evaluation included standardized history, clinical examination (including stress test), numbers of pads/24 h,, and objectively confirmed by complete urodynamic evaluation with Valsalva leak-point pressure (VLPP) recording according to the standards recommended by the ICS [7]. Both uroflowmetry results and post-void residual urine volume (PVR) were retrieved for comparison and assessment of postoperative voiding dysfunction and urethral obstruction. We used the validated Arabic translation of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) questionnaire to assess QoL before surgery, and at the 1 and 6-month postoperative visits [8]. The post operative scores were compared to baseline scores.

The women with SUI were randomized into two groups after inclusion using closed envelope: Group I included women who underwent TOT using hybrid tape and Group II who had a TOT using synthetic sling [DynaMesh®-SIS direct].In group I patients we start to harvest autologous graft from rectus fascia through small pfannenstiel incision the graft is 6 cm length and 2 cm width. We cut the synthetic tape in the center, and then suture the autologous part between the halves of the synthetic tape, and TOT (outside–in) was performed in both groups as described by Delorme et al. [9].

The procedure was timed from the first incision to the last suture, At the end the procedure vaginal pack was left for 12–24 h postoperatively, whilst an indwelling urethral Foley’s catheter (16F) was fixed for 1 day. Intraoperative and immediate postoperative complications, hospital stay, and return to normal activity were calculated.

Follow up Data from at 1 and 6-month postoperative visits were compared with the perioperative variables and QoL.

Descriptive statistical data, perioperative variables were recorded as mean ± SD, whilst postoperative surgical outcome in percentage for comparison between the groups .Statistical analysis was performed using paired t-test and z test, with a P ≤ 0.05considered to indicate statistical significance.

Table 1 shows Epidemiological characteristics of the study groups with no statistically significant difference between both groups. Past surgical histories of women in Group I and Group II were not significantly different. Both groups were comparable as regard pretreatment clinical assessment as, IC-IQ score, Q max, VLPP and PVR with insignificant statistical difference. The operating time was significantly longer in the hybrid tape (Group I) compared to synthetic tape (Group II). Blood loss was insignificant in both groups. The mean time to return to normal activity was significantly shorter in Group II patients compared to those in Group I. we had no patients needed bladder self- catheterization postoperatively. No bladder, vascular, nervous or intestinal injuries were encountered in either group. Post operative pain was measured using numerical rating scale [10]

[NRS]: 0 = ‘no pain’, 10 = ‘unendurable pain’). It was significantly higher in group The impact of surgery regarding clinical outcomes and complications [early or late] is shown in table 2 and 3. overall cure rate (defined as no more episodes of SUI or pad use) was statistically insignificant in both groups. Post operative nocturia, urgency, and urge incontinence rates were not significantly different between in both groups, and these cases were managed by medical treatment. Vaginal sling erosion was encountered in one case in group II which was managed by sling removal.

Stress urinary incontinence is a common problem in women causing significant morbidity and poor quality of life and requires surgical treatment for its management. Although autologous tapes were advocated in the past, they became less popular due to availability of easier and faster tension free tapes [11,12].

The present prospective study shows that hybrid tape (Group I) and TOT groups (Group II) showed similar rates of immediate success in treating the SUI. The success rate of 90% for hybrid tape in Group I patients, in our present study is comparable to the Mourad et al. [13] study.

But with no cases complicated by bladder injury compared to the previously mentioned study, which explained by use of TOT procedure in both groups in our study, while the other study was comparing autologous rectus sheath graft as pubovaginal sling with synthetic sling as TOT procedure. Our results were comparable to the study presented by El Gamal et al In 2012 who used similar hybrid sling for treating 44 female with SUI (14) with success rate about 92% with no cases of urethral or vaginal erosion, however Bong et al in 2006 reported in their study one case of vaginal erosion after similar hybrid sling where the urethra was supported by a strip of a biological mesh and the two arms were formed of polypropylene mesh. (15)

The hybrid tape procedure had a longer mean (SD) operative time of 45.3± 3.6 min, which was longer than the TOT procedure, at a mean (SD) of 29 (3.3) min. This difference is probably attributable to rectus sheath graft harvesting and preparation of the hybrid tape in Group I, and this was comparable with Sharma et al. (16) with longer operative time in autologous rectus sheath group ((55.60 _ 5.77vs 25.27 _ 4.32 min), In the present study, the both groups were associated with similar incidence of voiding problems. In group l , de novo urgency was found in 13.3%, which was comparable to that reported by Sharma et al [16] ( 13% in autologous group versus 20% in synthetic group) but higher than that reported by Mourad et al. (9.7 % versus 3.13%) (13). In the present study, perioperative complications, pain, QoL, and the immediate functional results (surgical outcome and voiding dysfunction) were evaluated at the 1- and 6-month postoperative follow-up visits. Hybrid tape group showed better improvement in IC-IC SF score and cure rate than synthetic group .These results were close to that reported by El Gamal et al [14] in their study using similar hybrid sling procedure with cure rate 92% and significant improvement in symptoms scores postoperatively. In another study presented by Mousa et al using autologous rectus fascia as a midurethral sling by TOT approach, similar results were reported was high cure rated 93% with no cases of erosion or bladder injury. (17)

There was one case of vaginal sling erosion in group II in our present study which is contrary to Mourad et al [13] but Cipullo et al. [18] reported in their study three cases of vaginal tape erosion which occurred few months after their procedure. The mean hospital stay and consequently return to normal activity were significantly shorter for Group II patients [mean (SD) 2.3 (0.1) days] compared with Group I [mean (SD) 8.4 (1.2) days], thus indicating that the TOT procedure with synthetic sling is the simpler operation. The complaint of groin pain was observed with in 53% of our patients in both groups (n = 32), which is consistent with results of Nazari et al. [19] and this resolved in all the patients at 2 weeks of the procedure.

Hybrid tape had a comparable efficacy and safety as synthetic sling during TOT for treatment of female SUI with lesser incidence of sling erosion. A study with longer duration of follow up and larger number of patients to assess the long term efficacy and safety of hybrid tape sling.

Conflict of interest

We have no conflict of interest to declare or funding to disclose

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Table 1. demographic and preoperative and operative criteria

	Group I	Group II	P-value (sig.)
Age (years)	41.8±7.03	43.1±5.4	0.41
BMI (Kg/m2)	28.8±0.86	28.8±0.95	0.92
Parity	3±1	3±1	0.6
Postmenopausal state	6(20%)	7(23.3%)	0.63
Pretreatment IC-IQ score	15.5±1.5	15.5±1.4	0.93
Pretreatment Q max (ml/sec.)	25.6±1.8	25.4±2.01	0.68
Pretreatment VLPP (cm H2O)	82.3±7.5	83.06±5.01	0.67
Pretreatment PVR (ml)	5±0.11	5±0.18	0.74
Operative time mean ± SD	45.3±3.6	29.5±3.5	<0.001**
Intra op complications Vaginal injury	0	1	0.26
Retropubic hematoma	1	0	0.26
Persistent Postoperative pain	6	2	0.03
Overall intra op complications	7	4	0.04
mean time to return to normal activity mean ± SD [days]	8.4 (1.2)	2.3 (0.1)	0.02

Table 2 Comparison of clinical outcomes between both groups as regard the 1st and 6th month visit

	Group I At 1^st moth visit	Group II At 1^st moth visit	P value	Group I At 6^th moth visit	Group II At 6^th moth visit	P value
	Group I At 1^st moth visit	Group II At 1^st moth visit	P value		Group II At 6^th moth visit	P value
IC-IQ score : median ± IQR	2±2	3±1.75	0.009*	1±2	2±1	0.001*
Q MAX mean ± SD	23.8±1.6	23.4±1.5	0.42	23±2	23±2	0.74
PVR median ± IQR	0±20	0±18.75	0.85	0±21.75	0±7.5	0.1
Cough stress test: - Positive - Negative	4 (13.3%) 26 (86.7%)	5 (16.7%) 25 (83.3%)	0.71	2 (6.7%) 28 (93.3%)	3 (10.3%) 26 (89.7%)	0.61
Overall outcome comparison between both groups: Failed Improved Cured	0 (0%) 4(13.3) 26(86.7%)	0 (0%) 5 (16.7%) 25(83.3%	0.71	0 (0%) 2 (6.7%) 28 (93.3%)	0 (0%) 3 (10.3%) 26 (89.7%)	0.61

Table 3 Comparison of clinical early amd late postoperative complications in both groups

Early [within 4 weeks post operative] Complications:

Urgency

Voiding dysfunction

4 (13.3%)

2 (6.7%)

4 (13.3%)

3 (10%)

0.89

Late Complications [after 4 weeks post operative]

Urgency

Voiding symp.

Vaginal erosion

2 (6.7%)

1 (3.4%)

0.71

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Version 1

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Hybrid tape versus synthetic tape in treatment of female stress urinary incontinence .A prospective clinical study

Status:

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Abstract

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What does this study adds to the clinical work?

Introduction

Patients and methods

Results

Discussion

Conclusion

Declarations

References

Tables

Status:

Version 1