TVT operation

TVT operation

Analysis of new surgical correction of urinary incontinence - TVT operation - at the Clinic of Obstetrics and Gynaecology at Kaunas University of Medicine (Lithuania)

Assoc. Prof. Rosita Aniuliene,
MD Sonata Bariliene
Obstetrics and Gynaecology Clinic at Kaunas University of Medicine, Lithuania

Requests for reprints should be addressed to:
Assoc. Prof. Rosita Aniuliene
Eiveniu 2, 50009
Kaunas, Lithuania
Tel.: +370 7 326929
e-mail address: rositaan@hotmail.com

Abstract

There are various surgical methods for the treatment of female urinary stress incontinence. Objective of the study: to evaluate the effectiveness of TVT operation based on the clinical practice aquired for three years and the possibility of its use in the outpatient bases. Study design: the patients were examined according to a standardized protocol for urinary incontinence and were operated according to the original "Gynecare TVT" protocol. 57 women were operated and followed up during the study period (2000.02.25 - 2002.12.31). Type of statistical analysis: "STATISTICA 5.5", "Excel 2000". Results: The average age was 53,2 years old, of which 31 women (54,4%) were after menopause and 56 (97,9%) gave childbirth. 9 women had operations in their medical histories, where 5 had hysterectomies and the other 4 were operated because of urinary incontinence. Among the operated women 6 had local anesthesia, 13 had epidural and 38 had lumbar anesthesia. The average time of the operation was 22,26 minutes. The average of the hospital stay was 4,37 days. The effectiveness of operation was 98,2%. Complications: perforation of the urinary bladder - 1 (1,8%), infection of urinary tract - 4 (7,0%). Conclusion: the TVT operation is a minimal invasive, fast, safe and a very effective surgical procedure for the treatment of urinary stress incontinence, which has to be implemented in Lithuania as a routine outpatient procedure.

Analysis of new surgical correction of urinary incontinence - TVT operation - at the Clinic of Obstetrics and Gynaecology at Kaunas University of Medicine

 

Introduction

Female urinary incontinence is a social, hygienic and psychological problem that torments women so much and causes disablement.

Main factors that influence urinary incontinence are age, pregnancies and childbirths, menopause, obesity, urinary tract diseases, recognition disorder, hysterectomies, work character. It is observed that women having cystocelle or genital prolapse sometimes hold the urine well, and women with normally stated genitals often have urinary incontinence.

Most often urinary incontinence occurs during physical load because of increased intraabdominal pressure and, consequently, increased mobility of cervicourethral block and insufficiency of urethra function. These are the main indications for surgical treatment.

Diagnostic is based on gynaecological and urological anamnesis, urination diary of the patient, examination, objective and bimanual analysis, cough, Valsalva, Boney, Q-tip (cotton swab), stress, pad tests and (in cause of mixed urinary incontinence, preparing for operative treatment) - on urodynamical examination: urethrocystometry, uroflowmetry and videourodynamics.

More than 200 surgical technics are used in the world for curing female urinary incontinence caused by physical load. Till 1970, the main surgical method of treatment has been anterior colporrhaphy. For last 20 years this operation has been criticized for big amount of relapses. More reliable results are got when applying retropubic surgical methods. Anterior colporrhaphy is effective when curing the descending of the side of vagina if there is no problem with urinary incontinence. In opinion of American Association of Urologists, from 4 categories of operations (anterior colporrhaphy, suburethral sling, colposuspenses and long needle sling) anterior colporrhaphy is the least effective for long period treatment [1]. Cochrane collaboration library gives comparative facts: results of 6 studies affirm that when applying anterior colporrhaphy in curing urinary incontinence to 1 year, 29% of results have been unsuccessful, after 1 year - 41%, on the contrary, while making abdominal colposuspension these data are 14% and 17% [2]. Suprapubic colposuspension or urethrosuspension is much more effective than vaginal operations [3].

Objectives of the study:

To evaluate the effectiveness results and complications of TVT operation.
To estimate the correlation between risk factors of urinary incontinence and post-operative complications.

 

Methods of the study:

Before the operation there was collected gynaecological and urological anamnesis, performed gynaecological examination, urinary examination, cough, Valsalva, Boney and stress tests. Women were examined 2, 6, 12 and 24 months after the operation. Including criterions - women having physical load urinary incontinence of I, II, III degree (according to Ingelman-Sundberg-Stamey classification) or mixed urinary incontinence with cystocelle of I, II, III degree who agree to buy single TVT set.

During the examination period (25-02-2000 - 31-12-2002) 57 women were operated according to original TVT operation protocol. Results of the operation were evaluated according to criterions accepted: very good - urine is held, no imperative urination or disury; good - urine is held, slight imperative urination, no disury; average - urine is held, imperative urination with minimal urinary outflow, slight disury; bad - urine is not held, imperative urination, disury, the woman wears pads [5].

 

Protocol of TVT operation

 

INDICATIONS FOR THE OPERATION:

  1. Stress urinary incontinence (I, II, III degree) with increased mobility of urethra and congenital insufficiency of sphincter.
  2. Mixed urinary incontinence.

 

CONDITIONS: genital prolapse of I?, II?, III?.

CONTRAINDICATIONS:

  1. Pregnancy.
  2. Childhood, adolescence.
  3. Pregnancy planned in the future.
  4. Genital prolapse of IV?, V?.

 

TVT equipment:

  • Apparatus of single use "GYNECARE TVT"
  • Intubator of multiple use
  • Stiff catheter turner of multiple use "GYNECARE TVT"

 

Results and discussion:

57 patients took part in the study. 95% reliable interval of women age is from 50,1 to 56,4 year. The youngest operated patient was 31 year of age, oldest - 82 years of age. Comparing these women according to amount of childbirths we have stated that contingent was homogenic, childbirth average 1,96 (1,74-2,19). 31 patient was in period of menopause. Average period of female urinary incontinence reached 6,5 (4,69 - 8,32) years. TVT operation was performed to 7 obese women (BWI>30). 5 women before the operation have suffered symptoms of irritable urinary bladder (in case of mixed incontinence). Besides, 3 women had laparotomic total hysterectomy, 1 - subtotal hysterectomy and 1 - vaginal hysterectomy before. Because of urinary incontinence 4 women were operated before: 2 women were operated in Kelly way, 1 - in open Burch way and 1 - in Stoeckel way (Table 1).

Operated women were observed after 2, 6, 12 and 24 months. Table 2 gives facts of our register. Effectiveness of the operation is rather high (98,2%) - it has been evaluated as very good and good results of the operation after 2 months (Table 3).

This paper gives the most attention to a new methodology - TVT operation that was done for the first time in Lithuania and the Baltic states on February 25, 2000, in assistance of Dr. T. T. Pentinnen (Finland). TVT operation is very effective, minimum invasive, it is widely used in the world for curing female urinary stress incontinence. Professor U. Ulmsten has done first new surgical correction of urinary incontinence - TVT operation - to a woman with urinary incontinence due to physical load at Upsala University Hospital in 1995 [4]

Our data are very similar to the data in foreign literature. L. M. Partoll also describes effectiveness of TVT operation - 94%. The author has operated 37 women due to stress urinary incontinence using TVT method [6].

In reviewing rather many publications of literature about surgical treatment of urinary incontinence, we would like to mention multicentral Nordic study where 90 women, operated according to TVT methodology have participated. The patients were observed for 5 years. Effectiveness of the operation reached 84.7% (n=72), 10.6% (n=9) of patients have indicated noticeable improvement and 4.7% (n=4) had no effect. The authors did not present any information about 5 patients left. No reactions of throwing off the foreign body were observed during the study. 25 women from 90 mentioned patients were included into the study because of mixed type of urinary incontinence. 14 patients after the operation suffered symptoms of irritable urinary bladder. In conclusion the authors assert that TVT operation justifies all hopes of surgeons staying the most effective operative treatment of female urinary incontinence [7].

Similar conclusion has been presented by S. L. Stanton. He asserts that minimal invasive methods such as TVT procedure get more successful and more light to the patient because of minimal pain, short hospitalization, few complications and outside phenomenon. Effectiveness of the operation reaches 88-96% [8].

Period of operation and in-patient treatment, method of anaesthesia and need of post-operative drainage of urinary bladder were compared with corresponding facts in the Central TVT register of Austria [9]. According to facts presented by Austrian urogynaecologic work group, average period of TVT operation is 30 minutes, average period of in-patient treatment - 4 days, local anaesthesia is applied in 46% of cases, regional - in 43% of cases. Periodical catheterization is necessary to 20% of patients. TVT operation it is possible to perform in intravenous anaesthesia.

T. S. Lo and co-authors have performed an interesting examination: they operated 45 women of 65-85 year of age with intravenous anaesthesia and deep sedation. Average period of the operation - 21 minute, post-operative period in inpatient department - 1-3 days. Effectiveness of the operation itself according to their data was very high (91%) [10].

In 1998 was already performed multicentral examination at six centres in Scandinavia where 131 woman have been operated. All operations were performed applying local anaesthesia. Average period of the operation - 28 minutes (19-41 minutes). 91% (n=119) of patients absolutely recovered, and 7% felt noticeable improvement. 90% of women were let out home the same day, others - the next day. Three patients have needed constant catheter for 3 days. Complications found: in 2 cases there were haematomas observed and in 1 case - perforation of the urinary bladder [11].

We have dynamically evaluated the post-operative results (Table 3). 6 months after very good post-operative results decreased (87,6%) and good results increased (10,7%), frequency of bad results did not change (1,8%). 12 months after the tendencies stayed the same: very good results decreased (72,3%) and good results increased (25,5%), therefore, post-operative results did not change essentially to most of women - they were very good or good. Comparing the last two periods, i.e. after 2 months and 12 months, frequency of bad results has slightly increased (0,3%).

Possibility for changing post-operative results after doing logistic regression analysis, we have stated that the amount of childbirths and the duration of operation statistically significant influenced the decreasing of post-operative results (Table 4). Every childbirth increased 2.29 times (p<0.05) the OR of decreasing of post-operative results. Every minute of operation this OR increased 1.21 time (p<0.05).

On the other hand, age, period of menopause and urinary incontinence did not influence decreasing of very good results to good (Table 4).

We have evaluated the correlation of various symptoms and risk factors (Table 5). The strongest connection was established between period of the operation and age and post-operative urinary retention. The correlation of other symptoms was slight or insignificant.

In our results we present all complications, even the slightest, that occurred in our examined group because it influenced longer period of hospitalization for the patients. In world literature authors present only the most distinctive complications during the TVT operation such as perforation of the urinary bladder or urinary tract infection [3]. In our study (Table 6) these complications were observed only in 5 cases (8,8%). Authors of the other countries indicate from 2 to 6% of similar complications [3].

A group of American authors that have examined the technique of TVT operation, ways out and complications assert that it is unique operation for treatment of urinary stress incontinence. Tape of "prolen mesh" that raises the middle part of urethra to physiological state, effectively cures urinary stress incontinenc (Picture 1). The "foreign substance" itself is well-tolerated, and the procedure is more effective than other corrective operations for urinary incontinence [12].

In our clinic there were no complications observed to more than half patients (61,3%) during the operation and after it. In 1 case suprapubic haematoma was observed that resorbed itself in early post-operative period when applying procedures of physiotherapy, in 2 cases (3,5%) haemorrhage from the wound was observed: one patient - day after the operation, other - on the 7th day when the patient was already at home.

After wading vagina to the latter patient the haemorrhage stopped and no operative interventions were needed. Perforation of the urinary bladder occurred in 1 case (1,8%), possibly because of atypical anatomy of the urinary bladder sticking the second needle into Retzium cavity. However, the urinary bladder was only pricked, the needle was taken out and the operation was finished in typical way. After the operation when performing supplementary cytoscopy with urologists a slight hurt in one point of the cavity was observed. Constant catheter was left to this patient for 7 days. The most frequent complication - post-operative urinary retention - occurred to 15,8% (n=9) of women. This index exceeds the literary facts possibly because of non-adequate strain of prolen tape [13].

Symptoms of irritable urinary bladder during early post-operative period occurred in 8,8% (n=5) cases, however, this was influenced by analogical pre-operative symptoms observed in 8,8 % (n=5) cases of mixed urinary incontinence. The urinary tract infection was found in 4 cases (7%). That is two times more frequently in comparing with literarure, however, it is difficult to compare these indexes with one another because the world literature gives facts from multicentral studies that have much more patients included [14].

After presenting the complications observed in detail, we have evaluated their connection with risk factors (Table 7). The strongest connection has been established in evaluating the age and post-operative urinary retention - the latter has increased when the age increased. Table 8 presents logistic regression analysis of complication risk factors that shows that the amount of childbirths did not influence the frequency of complications, and other indexes, especially the period of urinary incontinence, are connected with complications occurred.

Operations, combined with TVT (or simultaneous operations) are presented in Table 9. Anterior colporrhaphy has been performed in 8 (14,1%) cases seeking to remove the cystocelle. In 2 cases (3,5%) prolen mesh has been used and in 2 cases (3,5%) posterior colporrhaphy has been performed because of rectocelle. These combinations of operations had no influence to ways out or complications of TVT operation, only the period of the operation has increased for 10-20 minutes and period of patient hospitalization has increased for 2-3 days.

According to literary facts in the world, it is established that the most effective treatment for urinary incontinence because of physical load is used by performing TVT, laparoscopic and laparotomic Burch operations [3, 13, 15]. However, the economical advantage of quicker recovery of the patient, smaller amount of blood lost, shorter days in bed and smaller expenditures of labour is bigger when performing the TVT operation. At the time minimal invasive, effective and patient comfortable ways of treatment are looked for in the world. TVT operation is most like that: maximum advantage to the patient and pleasure to the operating surgeon. The one disadvantage of TVT operation in our country at the time is that the operation is not compensated by Territorial Patient Fund and patients have to buy the expensive set for the operation themselves.

 

Conclusions

  1. TVT operation is a very effective procedure while curing female urinary stress incontinence and mixed incontinence.
  2. The amount of childbirths in the anamnesis is connected with decreasing of post-operative results after 12 months.
  3. Early heavy post-operative complications after TVT operations have occurred in 8,8% cases.
  4. Post-operative urinary retention is connected with old age.
  5. Period of urinary incontinence in anamnesis is connected with complications of TVT operation.
  6. Operations combined with TVT did not make any influence to complications, however, they prolonged the period of the operation and bed stay.
  7. TVT operation is minimum invasive, economical, and it has to be implemented in Lithuania as a routine outpatient procedure for the treatment of urinary stress incontinence and mixed incontinence.

Table 1. Characteristics of patients operated in TVT method at Clinics of Obstetrics and Gynaecology in 2000-2002 (n=57)

Index Average (±95% PI) Limits n (%)
Age (years) 53,2 (50,1-56,4) 31-82
Amount of childbirths 1,96 (1,74-2,19) 0-5
Period of menopause (from 1 to 28 years) 10,26 (6,91-13,6) 1-30 31 (54,4)
Obesity (BWI>30)

7 (12,3)
Symptomatic of irritable urinary bladder in cause of mixed incontinence

5 (8,8)
Period of urinary incontinence (years) 6,5 (4,7-8,3) 1-28
Hysterectomy performed in the past

5 (8,8)
Operated due to urinary incontinence in the past

4 (7,0)
Period of observation (months) 22,9 (19,6-26,2) 2,1-48

 

Table 2. Facts in the register of TVT operation at the Clinics of Obstetrics and Gynaecology

Parameters of the register Average (±95% PI) Limits n (%)
Effectiveness of the operation 98,2%

Period of the operation (min.) 22,3 (20,8-23,7) 15-40
Period of the hospital stay (days) 4,7 (3,5-5,2) 1-14
Anaesthesia: local epidural lumbar


6 (10,5) 13 (22,8) 38 (66,7)
Drainage of urinary bladder: periodical catheterization

9 (15,8)

 

 

Table 3. Results of TVT operation during the observation period (information of the Clinics of Obstetrics and Gynaecology in Kaunas University of Medicine)

Results 2 months after n (%) 6 months after n (%) 12 months after n (%) 24 months after n (%)
Very good 54 (94,7) 49 (87,5) 34 (72,3) 12 (63,2)
Good 2 (3,5) 6 (10,7) 12 (25,5) 6 (31,6)
Mild - - - -
Bad 1 (1,8) 1 (1,8) 1 (2,1) 1 (5,3)
No information - 1 10 38

 

Table 4. Logistic regression analysis of risk factors of decreasing post-operative results (information of the Clinic of Obstetrics and Gynaecology in Kaunas University of Medicine)

Variable Exp (B) ±95% PI
p
Period of the operation (min.) 1,208 1,042-1,421 0,012
Age (years) 0,870 0,7538-1,0035 0,420
Period of menopause (years) 1,163 0,9565-1,415 0,380
Amount of childbirths 2,289 0,829-6,327 0,024
Period of urinary incontinence (months) 1,002 0,852-1,177 0,380

 

Table 5. Correlation of various factors (information of the Clinic of Obstetrics and Gynaecology in Kaunas University of Medicine)

Variable

Period of operation

Post-operative urinary retention

Amount of childbirths

Age

Period of menopause

Period of treatment in patient department

-0,083

-0,025


-0,069


0,101


-0,030


Period of the operation

0,109

0,036

-0,012

-0,068

Post-operative urinary retention

0,148

0,494**

0,354**

Amount of childbirths


-0,024

-0,263*

Age





0,751**

* - p<0.05, ** - p<0.01

 

Table 6. Early complications of TVT operation (information of the Clinic of Obstetrics and Gynaecology in Kaunas University of Medicine)

Complications

n (%)
No complications 35 (61,3)
Suprapubic haematoma 1 (1,8)
Haemorrhage from the wound in vagina 2 (3,5)
Perforation of urinary bladder 1 (1,8)
Post-operative urinary retention 9 (15,8)
Symptoms of irritable urinary bladder 5 (8,8)
Infection of urinary tract 4 (7,0)

 

Table 7. Connection between complications and risk factors (information of the Clinic of Obstetrics and Gynaecology in Kaunas University of Medicine)

Complication/Risk factors

Age

(</? 50 years)

Childbirth

(yes/no)

Menopause

(yes/no)
Period of urinary incontinence (</? 10 years)
Haemorrhage from the wound of vagina 1/1 1/0 0/0 1/0
Suprapubic haematoma 0/1 1/0 1/0 1/0
Post-operative urinary retention 1/9 1/1 1/1 1/1
Symptoms of irritable urinary bladder 0/5 1/1 1/0 0/1
Infection of urinary tract 1/3 1/1 1/1 1/1

 

Table 8. Logistic regression analysis of complication risk factors (information of the Clinic of Obstetrics and Gynaecology in Kaunas University of Medicine)

Variable

Exp (B) ±95% PI p
Age (years) 1,004 0,922-1,095 0,920
Period of menopause (years) 1,091 0,960-1,240 0,180
Amount of childbirths 0,659 0,279-1,555 0,341
Period of urinary incontinence (months) 1,143 1,008-1,296 0,038

 

Table 9. Operations combined with TVT (n=12) (information of the Clinic of Obstetrics and Gynaecology in Kaunas University of Medicine)

Operative procedure

n (%) n=57 (%)
Anterior colporrhaphy 8 (66,6) 14,1
Prolen mesh application for liquidating the cystocelle 2 (16,7) 3,5
Posterior colporrhaphy (colpoperineoplastic) 2 (16,7) 3,5

References

  1. Leach GE, Dmochowski RR, Appell RA, Blaivas JG, Hadley HR, Luber KM, et al. Female stress urinary incontinence clinical guidelines. J Urol 1997; 158:875 - 80.
  2. Glazener CM, Cooper K. Anterior vaginal repair for urinary incontinence in women. Cochrane Database Syst Rev 2003;CD001755.
  3. Incontinence. Editors: Paul Abrams - Saad Khoury - Alan Wein. 1st. International Consultation of Incontinence. June 28- July 1. 1998. Monaco.
  4. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996.; 7:81 - 86.
  5. Černiauskienė A. Moterų šlapimo nelaikymas. Lietuvos Akušerija ir ginekologija. 2002; 5(1): 37-42.
  6. Partoll L.M. Efficacy of tension-free vaginal tape with other pelvic reconstructive surgery. Am J Obstet Gynecol 2002 Jun 186(6): 1292-1295.
  7. Nilsson C.G, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the TVT procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J. 2001; Suppl.2: 5-8.
  8. Stanton S.L. Tension-free vaginal tape - a minimally invasive surgical procedure for the treatment of female urinary incontinence. Int Urogynecol J. 2001; 12(8): 1-2.
  9. Tamussino K, Hanzal E, Kölle D, Ralph G, Riss P. "The Austrian Tension - free vaginal tape registry". Int.Urogynecol J (2001) (Suppl 2) S:28-29.
  10. Lo T.S, Huang H.J, Chang C.L, Wong S.Y, Horng S.G, Liang C.C. Use of intravenous anesthesia for tension-free vaginal tape therapy in olderly women with genuine stress incontinence. Urology 2002. Mar; 59(3): 349-353.
  11. Ulmsten U, Falconer, Johnson P. et all. A multicenter study of Tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J 1998.; 9:210 - 213.
  12. Brophy M.M, Klutke J.J, Klutke C.G. A review of the tension-free vaginal tape procedure: outcomes, complications and theories. Curr Urol Rep. 2001 Oct; 2(5): 364-369. (USA).
  13. Laparoscopic colposuspension for urinary incontinence in women. Moehrer B., Ellis G., Carey M., Wilson P.D. The Cochrane Library, Issue 3,2002.
  14. Wang A.C. "An assessment of the early surgical outcome and urodynamic effects of the TVT. Int Urogynecol J Pelvic Floor Dysfunct 2000; 11(5): 282-284.
  15. Suburethral sling operations for urinary incontinence in women. Bezerre C.A., Bruschini H. The Cochrane Library, Issue 3,2002.