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Long-term efficacy

Long-term efficacy
Long-term efficacy

ORIGINAL ARTICLE

Long-term efficacy of tension-free vaginal tape

in the management of stress urinary incontinence in women:efficacy at5-and7-year follow-up

A.Liapis&P.Bakas&G.Creatsas

Received:22February2008/Accepted:18May2008/Published online:10June2008

#The International Urogynecological Association2008

Abstract The objective of the study was to obtain a prospective assessment of the efficacy and the complica-tions associated with the use of tension-free vaginal tape (TVT)for the management of urodynamic stress inconti-nence at5-and7-year follow-up.Sixty-five female patients with stage I cystocele or less who have been operated with TVT procedure for management of urodynamic stress incontinence have been included in the study.At5-year follow-up,the objective cure rate was83%and failure rate 9.4%.At7-year follow-up,the objective cure rate was80% and the failure rate13.5%.De novo detrusor overactivity was seen in9.4%and11.4%of patients at5-and7-year follow-up,https://www.sodocs.net/doc/8e10791730.html,T operation is an effective and safe minimally invasive procedure for the management of urodynamic stress incontinence in women without signifi-cant cystocele in the long-term follow-up.The10-and20-year results are awaited.

Keywords Efficacy.Long term.Results.

Stress https://www.sodocs.net/doc/8e10791730.html,T.Urinary incontinence Introduction

The tension-free vaginal tape(TVT)is a relatively new procedure that has been designed for the surgical manage-ment of stress urinary incontinence in women.It has been introduced since1995[1]and has achieved worldwide popularity since then.The short-term results of the proce-dure have been encouraging[2]and are comparable to the Burch colposuspension,which is considered the most suc-cessful operation for stress urinary incontinence in women available to date.In addition,it is characterized by less operative time,significantly less surgical complications and postoperative voiding dysfunction,less hospitalization time,and faster recovery[3,4].During the last few years, the long-term results of TVT procedure started appearing in the literature[5],but there are limited data yet.In this study, we present our experience in relation to long-term efficacy of TVT procedure for the management of stress urinary incontinence in women.

Materials and methods

Seventy consecutive patients have been included in this study.It was estimated that,for a type I error-alpha0.10 and a type II error-beta0.10(power of the study90%)and an82%success rate for TVT at5years follow-up,null hypothesis value to detect a success rate of65%requires a sample size of at least54patients.

This prospective study took place in the2nd Department of Obstetrics and Gynecology of the University of Athens.All patients were asked via telephone call to come for follow-up and underwent postoperative urodynamic assessment.

All patients had a full history taken and a complete gynecological examination performed at initial visit,and frequency–volume charts were completed for2–4days. Preoperative urodynamic investigations included filling and voiding cystometry,uroflow,and1-h pad test.Stratification of severity of stress incontinence was based on the classifi-cation of pad weight gain suggested by the5th Report of the International Continence Society,Bristol,https://www.sodocs.net/doc/8e10791730.html,d to moderate urine loss was observed in31.4%of patients,

Int Urogynecol J(2008)19:1509–1512

DOI10.1007/s00192-008-0664-1

A.Liapis(*)

:P.Bakas:G.Creatsas

2nd Department of Obstetrics and Gynecology, Aretaieio Hospital,University of Athens,

N.Paritsi9A,N.Psichiko,

15451Athens,Greece

e-mail:p_bakas@https://www.sodocs.net/doc/8e10791730.html,

severe loss in45.8%,and very severe loss in22.8%of patients.Patient assessment at5-year follow-up included gynecological examination,filling and voiding cystometry, uroflow,and1-h pad test,and at7years follow-up included filling and voiding cystometry,uroflow,and a simple patient satisfaction questionnaire.Urodynamic stress incon-tinence diagnosis was based on the findings of urodynamic investigation.Diagnosis of detrusor overactivity was based on cystometric findings.All patients had USI with stage I prolapse or less of the anterior compartment according to the International Continence Society classification(ICSC). Patients with urodynamic findings of detrusor overactivity, previous operation in the genital tract or maximum urethral closure pressure of less than20cmH2O,prolapse of the anterior compartment greater than stage I according to ICSC,or prolapse of the middle or posterior compartment requiring management were excluded from the study.All patients were operated on with epidural anesthesia.All patients signed an informed consent,and approval of the hospital ethical committee was obtained.The outcome of the operation was assessed both subjectively and objec-tively.Objective assessment was based on the findings of cough stress test by asking the patient to cough with the bladder filled with400–450ml of normal saline or filled up to maximum cystometric capacity.At5-year follow-up, objective cure was considered as the absence of urine leaking during cough test in lithotomy or upright position and a pad test weight of<1g,and improvement as the reduction of urine loss to less than50%of urine loss they experienced before the operation.This was based on the findings of the1-h pad test.Subjective cure was defined as no loss of urine with exercise,coughing,or weight lifting and improvement as a subjectively significant reduction of the leaking episodes,expressed by patients’satisfaction. At7-year follow-up,objective cure was considered as the absence of urine leaking during cough test in lithotomy and upright position.In subjective cure,improvement and failure were assessed with the use of a simple question-naire that patients answered during their examination (“Appendix”).Statistical analysis was performed for vari-ables following normal distribution with the Student’s t test for independent samples and for variables not following normal distribution with the Mann–Whitney test for independent samples.A p<0.05was considered statistically significant.The software used for statistical analysis was Medcalc version7.6.0.0.

Results

Of the70patients,five were lost at5-year follow-up(three patients could not be located and two patients could not come for follow-up because they were living far away from the clinic).At7-year follow-up,four additional patients were excluded because two of them had died from natural causes and two were living in a nursing home and could not attend for follow-up.The patients’characteristics are shown in Table1.The objective cure rate was83%at5-years and 80%at7-year follow-up.In the objective cure rate at5-and 7-year follow-up,the patients having pure urge urinary incontinence have been included because they have been considered treated from their initial problem that was pure stress urinary incontinence.Total success rate,improve-ment,and failure rates at5-and7-year follow-up are presented in Tables2and3.Cystocele grade II or higher was seen in9.2%of patients at5-year follow-up and in 12.5%at7-year follow-up.

At5-year follow-up,de novo detrusor overactivity was seen in8%(5/65)of patients and urgency in12.3%(8/65) of patients.Out of the five patients with detrusor over-activity,one patient had mixed incontinence and four patients had urge urinary incontinence(6.5%).Three out of five patients complained of dysuria,but they had postvoid residual volume(PVR)of urine of less than 100ml and peak flow rates(PFRs)of17.8,13.4,and 13.8ml/s,respectively.

At7-year follow-up,de novo detrusor overactivity was seen in11.4%(7/61)of patients and urgency in19.6% (12/61).Out of seven patients with detrusor overactivity, two patients had mixed incontinence and five patients had urge urinary incontinence.Four out of seven patients complained of dysuria,and two of them had80and60ml PVR and13.4and13.8ml/s PFR,respectively,while the rest of the patients had PFR>15ml/s and PVR<100ml (Table4).At5-year follow-up,the median age of patients with bladder overactivity was72(range55–78),and at7-year follow-up the median age was72(range57–80). At7-year follow-up,overall subjective dysuria was14.7% (9/61),but PVR was normal(median5ml,range0–60ml), and PFR median was16.2ml/s(range13.4–24ml/s). Recurrent lower urinary tract infection was seen in3.2%of patients(2/61),but they had no complaints of dysuria or incontinence.

We had one case of TVT tape erosion developed at 29months postoperatively which was treated by cutting the TVT tape edges which were projecting through the vaginal Table1Patients’characteristics at7-year follow-up

Values(N=61) Age(years)58.1±10.4 Parity2±1.1

BMI26.8±2.3 Menopausal70.4%

BMI Body mass index

mucosa.The rest of the patients had no evidence of tape erosion at7-year follow-up.

Discussion

The introduction of TVT procedure for the management of stress urinary incontinence in women was based on the integral theory.According to such theory,the female urethra is closed at the level of the midurethra and not at the bladder https://www.sodocs.net/doc/8e10791730.html,ck of support of the midurethra from the pubourethral ligaments and from the suburethral anterior vaginal wall and defective function and insertion of pubococcygeal muscles predisposes one to stress urinary incontinence[6,7].The purpose of the TVT procedure is to reinforce the midurethral support,and it uses a polypro-pylene mesh tape that is inserted beneath and around the midurethra[8].

The efficacy of TVT procedure in the short term has been reassuring and very encouraging,and this is supported by several papers[2,9,10].

In the present study,the objective cure rate is83%,the objective improvement is7.8%,and the failure rate is9.2% at5-year follow-up,while there is no significant difference from the results of subjective assessment.These results are similar with the84.7%[11]and94.5%[12]for pure stress urinary incontinence that has been reported,and it is comparable with the78%for pure stress urinary inconti-nence that has been published[13].At7-year follow-up, the objective cure rate is80%,the objective improvement is 6.5%,and the failure rate is13%.These findings are comparable with the81.3%cure rate that has been reported by Nilsson et al.[14].De novo detrusor overactivity was seen in11.4%of patients,while in the Nilsson et al.series de novo urge symptoms were 6.3%.The presence of detrusor overactivity was not associated with significant obstructive findings from the lower urinary tract and could at least be partly attributed to the aging of the patients.

These findings support that TVT procedure maintains its very good short-term efficacy in the long term,and it is very satisfactory for the patients and the physicians.We had no significant intraoperative complications,and we had no patients with voiding difficulties in the long term.There was only one case of erosion of vaginal mucosa by TVT tape,which was treated by cutting the edges of the TVT tape,and the patient remained continent.Its clinical presentation was as a sharp foreign body in the vagina, making sexual intercourse for her husband painful.These results are comparable with the Burch colposuspension [15],while TVT procedure is much less invasive,with fast recovery time and low rate of complications.However, Burch colposuspension presents a time-dependent decline in its efficacy,having a surgical success decline to62%at more than10-year follow-up[16];at14or more years of follow-up,subjective cure rate could be reduced to44% [17].It has to be seen in the near future if the use of TVT tape as prosthetic material and the fibrotic tissue that is developed around it could maintain their function in the long term,preventing stress urinary incontinence.The incidence of de novo urgency at5-year follow-up was 12.3%,which is in agreement with the results published by Doo et al.[13]wherein they report11.5%incidence of de novo urgency and urge incontinence,higher than the6% incidence of de novo urgency reported by Chene et al.[12].

Table3Outcome of surgery at7-year follow-up

Values Percentage

Objective

Cure49/6180 Improvement4/61 6.5 Failure

Mixed incontinence2/61 3.2 USUI6/619.8 Subjective

Cured48/6178.7 Improved5/618.1 Failed8/6113.1 USUI Urodynamic stress urinary incontinence Table4Findings of filling and voiding cystometry at5-and7-year follow-up

5years

(65patients)

7years

(61patients)

p

First desire(ml)95.2±31.398.3±29.5 Maximum cystometric

capacity(ml)

363.2±60.7362.4±57.7NS

Maximal flow rate(ml/s)16.7±1.816.6±2NS Postvoid residual(ml)12.9±19.315.5±19.4NS NS No statistically significant difference

Table2Outcome of surgery at5-year follow-up

Values Percentage Objective

Cure54/6583 Improvement5/657.6 Failure

Mixed incontinence1/65 1.5 USUI5/657.6 Subjective

Cured55/6584.6 Improved3/65 4.6 Failed7/6510.7 USUI Urodynamic stress urinary incontinence

At7-year follow-up,the incidence of de novo urgency was 19.6%,while other studies have reported an incidence of de novo urge symptoms at6.3%[5].The higher incidence of de novo urgency in the present study could be possibly attributed to the relatively smaller number of patients studied compared to that of other studies and to the aging of patients,which could contribute to a higher incidence of de novo urgency.

TVT procedure maintains a high efficacy at5-and7-year follow-up,which is comparable with the Burch colposuspension,but its efficacy at10-and20-year follow-up remains to be https://www.sodocs.net/doc/8e10791730.html,T procedure for the management of urodynamic stress incontinence appears to be a cost-effective technique at5-and7-year follow-up. Conflicts of interest None.

Appendix

1.Do you feel cured from your stress urinary incontinence

after the operation you had?

YES NO

2.Do you think that your incontinence has been improved

after the operation you had?

YES NO

3.Do you think that you are about the same or worse after

your operation for the management of your stress urinary incontinence

About the same YES NO

Worse YES NO

References

1.Ulmsten U,Petros P(1995)Intravaginal sling-plasty(IVS).An

ambulatory surgical procedure for treatment of female urinary incontinence.Scand J Urol Nephrol29:75–82

2.Ulmsten U,Johnson P,Rezapour M(1999)A three-year follow up

of tension free vaginal tape for surgical treatment of female stress urinary incontinence.Br J Obstet Gynecol106:345–350

3.Ward K,Hilton P(2002)Prospective multicentre randomized trial

of tension-free vaginal tape and colposuspension as primary treatment for stress urinary incontinence.Br Med J325:67–73 4.Liapis A,Bakas P,Creatsas G(2002)Burch colposuspension and

tension-free vaginal tape in the management of stress urinary incontinence in women.Eur Urol41:469–473

5.Nilsson CG,Kuuva N,Falconer C,Rezapour M,Ulmsten U

(2001)Long term results of the tension free vaginal tape procedure for surgical treatment of female stress urinary inconti-nence.Int Urocynecol J56(Suppl2):S5–S8

6.Petros P,Ulmsten U(1990)An integral theory of female urinary

incontinence.Experimental and clinical considerations.Acta Obstet Gynecol Scand69(Suppl153):7–31

7.Petros P,Ulmsten U(1993)An integral theory and its method for

the diagnosis and management of female urinary incontinence.

Scand J Urol Nephrol153:1–93

8.Ulmsten U,Henriksson L,Johnson P,Varhos G(1996)An

ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence.Int Urogynecol J7:81–86

9.Lo Ts,Chang TC,Chao As,Chou HH,Tseng LH,Liang CC

(2003)Tension-free vaginal tape procedure on genuine stress incontinent women with coexisting genital prolapse.Acta Obstet Gynecol Scand82:1049–1053

10.Karram MM,Segal JL,Vassallo BJ,Kleeman SD(2003)

Complications and untoward effects of the tension free vaginal tape procedure.Obstet Gynecol101:929–932

11.Liapis A,Bakas P,Creatsas G(2001)Management of stress

urinary incontinence in women with the use of tension-free vaginal tape.Eur Urol40(5):548–51

12.Chene G,Amblard J,Tardieu AS,Escalona JR,Viallon A,Fatton

B,Jacquetin B(2007)Long term results of tension-free vaginal tape(TVT)for the treatment of female urinary stress incontinence.

Eur J Obstet Gynecol RB134:87–94

13.Doo CK,Hong B,Chung BJ,Kim JY,Jung HC,Lee KS,Choo

MS(2006)Five year outcomes of the tension free vaginal tape procedure for treatment of female stress urinary incontinence.Eur Urol50:333–338

14.Nilsson CG,Falconer C,Rezapour M(2004)Seven year follow

up of the tension-free vaginal tape procedure for treatment of urinary incontinence.Obstet Gynecol104:1259–1262

15.Jarvis GJ(1994)Surgery for genuine stress incontinence.Br J

Obstet Gynecol101:371–374

16.El-Toukhy T,Mahadevan S,Davies AE(2000)Burch colposuspen-

sion:a10to20years follow up.J Obstet Gynecol20:178–179 17.Kjohede P(2005)Long term efficacy of Burch colposuspension:a

14years follow up.Acta Obstet Gynecol Scand84:767–772

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