TVT ir TVTO

Tension - free vaginal tape (TVT) versus Tension- free vaginal tape obturator (inside - outside) TVT-O in the surgical treatment of female stress urinary incontinence

Summary:

Objectives - to compare TVT (tension-free vaginal tape) and TVT-O (tension-free vaginal tape obturator from inside to outside) for the female surgical treatment of stress urinary incontinence: results, complications, effectiveness after 1 year.

Material and methods:

Prospective randomized study. Follow up period - 12 months. 114 patients were operated using TVT operation and 150 patients - TVT-O operation. There was no significant difference between groups for age, BMI (body mass index), parity, menopausal status and prolapse (no patients had cystocele greater than stage II).

Results: Mean operative time was significantly shorter in the TVT-O group (19 ± 5,6 min.) compared with the TVT group (27 ± 7,1 min.). There was no differences in the effectiveness of both procedures: TVT - 94,6% and TVT-O - 94,6% after one year. Hospital stay was statistically significantly shorter in TVT-O group (1,5 ± 0,5 days) than in TVT group (4,0 ± 1,6 days). Significantly less complications was in TVT-O group.

Conclusion: TVT and TVT-O operations are equally effective for the surgical treatment of female stress urinary incontinence. TVT-O had a shorter operation time and lower complications rate.

Introduction

Since 1995 the tension-free vaginal tape (TVT) technique has been the most commonly used surgical treatment for stress urinary incontinence [1]. A new surgical technique that uses polypropylene tape with new designed specific surgical instruments called transobturator vaginal tape from inside to outside or tension-free vaginal tape obturator from inside to outside (TVT-O) was described first time in 2003 [2].

If compare TVT and TVT-O procedures, these operations are equally effective in the treatment of female stress urinary incontinence, but TVT-O seems to be safer than the classic TVT [3, 4, 5].

This study was undertaken to compare prospectively the TVT procedure concerning the effectiveness, safety and simplicity with the TVT-O procedure.

 

Material and methods

114 patients were subjected to TVT procedure and 150 to TVT-O procedure. All those patients were available for follow-up at 12 months.

Inclusion criteria: women with stress urinary incontinence and patient's agreement to buy TVT or TVT-O equipment by herself (there is no compensation from territorial patients funds in Lithuania).

Exclusion criteria: urogenitale prolapse greater than stage II ,urinary retention, overactive bladder and psychiatric disease.

All patients had typical medical history of stress incontinence. The degree of the incontinence was 2 - 3 according to Ingelman-Sundberg scale.

Number of birth, obesity, menopause, urinary incontinence period, hysterectomy in the past and incontinence operations in the past of all patients was estimated.

A gynecological examination was performed for all patients. A stress provocation test was performed in the supine and standing positions with a comfortably filled bladder (300 ml) before and post operation.

Urodynamic evaluations were performed for 40% of patients ( in TVT group n = 44,in TVT-O group - n = 62) in a accordance with criteria established by the International Continence Society (ICS) [6].

The degree of vaginal defects was evaluated using the pelvic organ prolapse quantification (POP-Q) system [7].

Cystoscopy and cough test was routenly performed only in the TVT group.

Antibiotic prophylaxis was performed for all operations during surgery.

Foley catheter was left for 12 hours in TVT group and for 6 hours in the TVT-O group after operation.

Surgical procedures (TVT and TVT-O) were performed by the same surgeon (Rosita Aniuliene), using standardized Gynecare protocol.

Results were estimated according criteria:

  • Excellent - no signs of stress incontinence, no imperative urination, no disuria.
  • Good - no signs of stress incontinence, very mild imperative urination, no disuria.
  • Medium - no signs of stress incontinence, imperative urination with minimal leakage, very mild disuria.
  • Bad - stress incontinence, imperative urination, disuria, woman uses inlays.

Statistical analysis was performed with the use of Student's test and X2 test and p<0,05 was considered statistically significant.

Results:

All patients (TVT group n = 114 and TVT-O group n = 150) were assessed for eligibility. They agree to buy single equipment for operation, met the inclusion criteria and signed informed consent. All patients were operated in Kaunas University hospital, department of obstetrics and gynecology ( by the same surgeon- Rosita Aniuliene).

Patient characteristics are shown in the Table 1. There is no significant changes between the two groups for age, BMI, menopausal status and prolapse stage (no patients had cystocele greater stage II).

Also there was no difference in the duration of stress urinary incontinence (table 1).

 

Table 1. Patients characteristics

Patients characteristics TVT (n = 114) TVT-O (n = 150) p

Age ± SD

51 ± 10,1 49 ± 9,5 NS

POP Q system: Stage 1

Stage 2

26 31 NS
22 29 NS

Follow up period (months)

12 12 NS

BMI, kg/m2

27,9 ± 4,0 28,2 ± 3,8 NS

Number of birth

2,6 ± 1,1 2,5 ± 1,2 NS

Birth weight > 3500 g

49 ± 1,2 51 ± 1,3 NS

Menopause (1 - 30 years)

48 47 NS

Obesity (BMI > 30)

14 16 NS

Irritated bladder symptoms

6 5 NS

Urinary incontinence period

6,5 ± 3,1 7,5 ± 2,4 NS

Hysterectomy in the past

15 21 NS

Operated incontinence in the past

16 18 NS

 

As shown in the table 2 there was no differences in the effectiveness of both procedures (TVT - 94,6%, TVT-O - 94,6%). Mean operative time was significantly shorter in the TVT-O group (19 ± 5,6 min.) compared with the TVT group (27 ± 7,1 min.). Hospital stay was statistically significantly shorter in TVT-O group (1,5 ± 0,5 days) than in TVT group (4,0 ± 1,6 days). Bladder drainage was significantly rare in the TVT-O group (3,3%) compare with TVT group (15,8%).

Main type of anesthesia in TVT group was lumbar (83,3%) and in TVT-O group - intravenous (85,3%).

 

Table 2. TVT and TVT-O procedure register data

Register parameters TVT (n = 114) TVT-O (n = 150) p

Effectiveness of procedure

94,6%

94,6%

NS

Duration of procedure

27 ± 7,1

19 ± 5,6

p<0,05

Hospital stay (days)

4,0 ± 1,6

1,5 ± 0,5

p<0,05

Anesthesia: Epidural

13 (11,4%)

0

 

Local

2 (1,8%)

0

 

Lumbar

95 (83,3%)

22 (14,6%)

 

Intravenous

4 (3,5%)

128 (85,3%)

 

Bladder drainage:

- Interrupted catheterization

18 (15,8%)

5 (3,3%)

p<0,05

 

As shown in the table 3, the operation results in both group were similar. Bad results in TVT group - 3 cases and in TVT-O group - 3 cases. Medium - in TVT group (n=3), in TVT-O (n=5), good results in TVT group (n=11) in TVT-O (n=25) and excellent results in TVT group (n=97) in TVT-O (n=117).

 

Table 3. TVT and TVT-O procedures follow up results.

Results

(after 1 year)

TVT

N = 114

TVT-O

N = 150

Excellent

97 (85,0%)

117 (78%)

Good

11 (9,6%)

25 (16,6%)

Medium

3 (2,6%)

5 (3,3%)

Bad

3 (2,6%)

3 (2%)

 

As shown in table 4, significantly less complications was in TVT-O group. Suprapubic hematoma was occur 0,8% in TVT group and bladder perforation was 1 case in TVT group . Postoperative urinary retention significantly higher in TVT group (15,8%) than in TVT-O group (3,3%). There was no significant difference in such complications how: symptoms of irritated bladder. Infection of urinary tract in TVT group was in 4,4% and TVT-O group - 0,6%.

Table 4. Postoperative complications

Complications

TVT

(n = 114)

TVT-O

(n = 150)

p

No

81 (71,0%)

135 (90,0%)

P<0,05

Suprapubic hematoma

1 (0,8%)

0

NS

Wound bleeding in vagina

2 (1,8%)

3 (2%)

NS

Bladder perforation

1 (0,8%)

0

NS

Postoperative urinary retention

18 (15,8%)

5 (3,3%)

P<0,05

Symptoms of irritated bladder

6 (5,3%)

5 (3,3%)

NS

Infection of urinary tract

5 (4,4%)

1 (0,6%)

NS

Temperature > 38?C

0

1 (0,6%)

NS

Discussion

In the present study no statistically significant differences were noted between the two groups concerning the age, parity, menopause status, duration of urinary incontinence and degree of prolapse.

There was a significant statistical difference in the mean operative time and it was much longer in the TVT procedure than in TVT-O method, because in the TVT group was need of intraoperative cystoscopy [8]. The duration of hospitalisation statistically significant longer was in TVT group (4,0 ± 1,6 days), how in TVT-O group - 1,5% ± 0,5 days.

The results are not in agreement with other authors [9], where the majority of patients were discharged from the hospital on the first postoperative day.

Effectiveness of procedure (or cure rate) was 94,6% in TVT group and 94,6% in TVT-O group. These results are in agreement with other authors with a range of cure rate from 84% to 95% [10, 11, 12, 13,27].

Bladder perforation in our study was in 0,8% in TVT group and it is less then reported in the literature [10, 14, 15].

Postoperative urinary retention significantly higher was in TVT group (15,8%), so our data disagree with the literature [16].

Postoperative infection of urinary tract in TVT group was 4,4% and in TVT-O group - 0,6% (less like reported in the literature) [15].

Wound bleeding in TVT group was 1,8% and TVT-O - 2,0%. 1 patient was treated surgically and 4 - conservatively.

Duration of TVT-O operation was shorter than TVT, because in TVT-O procedure there was no need to perform cough test and cystoscopy.

TVT is a safe and effective surgical treatment of female stress urinary incontinence with a good effectiveness [17, 18, 19, 20,26], but TVT is associated with various perioperative complications [21, 22, 23, 24].

Several suburethral tape insertion procedures have been described such as tension-free trans-obturator tape (TOT) either from outside to inside or inside to outside [2,24, 25, ]. One retrospective comparative study, investigating retropubic and outside - in transobturator sling, demonstrated that these procedures are equally efficacious to treat female stress urinary incontinence with a cure rate of 90% versus 84% for TOT and TVT, respectively [3].

 

Conclusions

1. TVT and TVT-O operations are very effective procedures while curing female stress incontinence after 12 month of follow-up.

2. TVT-O procedure had a shorter operation time and hospital stay.

3. TVT-O had less complication rate than TVT operation.

 

Laisvai traukiama makšties kilpa (angl. tension free vaginal tape - TVT) ir laisvai traukiama obturatorinė kilpa (angl. Tension- free vaginal tape obturator - TVT-O) - moterų fizinio krūvio šlapimo nelaikymo chirurginių gydymo metodų palyginimas

Rosita Aniulienė

Kauno medicinos universitetas

 

Santrauka:

Tikslas: palyginti moterų fizinio krūvio šlapimo nelaikymo chirurginio gydymo metodų: laisvai traukiamos makšties kilpos (TVT) ir laisvai traukiamos obturacinės kilpos (TVT-O) rezultatus, komplikacijas, efektyvumą vienų metų laikotarpyje.

Medžiaga ir metodai: atsitiktinis perspektyvinis tyrimas. 114 pacienčių operuota, naudojant TVT metodą ir 150 pacienčių - TVT-O metodą. Vertinant amžių, KMI, gimdymų skaičių, menopauzės laiką ir makšties slinkimo stadiją (nebuvo pacienčių su didesne nei antra priekinės makšties sienelės slinkimo stadija). Tarp grupių statistiškai reikšmingo skirtumo nebuvo.

Rezultatai:

Vidutinė operacijos trukmė TVT-O grupėje buvo trumpesnė (19 ± 5,6 min.) lyginant su TVT grupe (27 ± 7,1 min.). Nebuvo statistiškai reikšmingo skirtumo šių operacijų efektyvume: TVT - 94,6% ir TVT-O - 94,6% efektyvumas po vienų metų. Po TVT-O operacijų stebima statistiškai reikšmingai trumpesnė hospitalizacijos trukmė - 1,5 ± 0,5 dienos, kai po TVT operacijų - 4,0 ± 1,6 dienos. Statistiškai reikšmingai mažiau komplikacijų stebėta TVT-O grupėje.

Išvados: TVT ir TVT-O operacijos yra vienodai efektyvios, gydant chirurginiu būdu moterų fizinio krūvio šlapimo nelaikymą, TVT-O operacija trunka trumpiau ir sukelia mažiau komplikacijų nei TVT operacija.

 

References:

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