Nursing and Health Care (ISSN: 2573-3877)

Research Article :

Long Term Quality of Life after Tension-Free Vaginal Tape-Obturator Procedure in Women with Stress Urinary Incontinence


Athanasios Farfaras, Stefanos Antoniou and Panagiotis Skolarikos

Abstract

Introduction:   

Stress  urinary  incontinence  represents  a  common  but  strongly  underestimated health problem that affects women of all ages and severely downgrades  their health related quality of life. The transobturator vaginal tape (TVT-O) approach  offers  long  term  success  rates,  while  minimizing  complications.  In  this  study,  we  examined  quality  of  life  of  patients  suffering  by  stress  urinary  incontinence  and  investigated whether TVT-O procedure offers considerable benefits in patients quality  of life after 5 years of placement.

Methods and results:  

Women with confirmed urodynamic stress  urinary incontinence  that underwent TVT-O procedure were included in this prospective study. Patients  quality of life was evaluated by using the Greek version of SF-36 preoperatively and 60  months postoperatively. The outcomes demonstrated that incontinence had significant  adverse effect in patients quality of life. However, TVT-O procedure offers a safe and  efficient  treatment,  substantially  improving  both  physical  and  mental  dimension  of  womens health related quality of life (P>0.05).

Discussion:  

Stress urinary incontinence strongly impairs womens health related  quality of life, limiting their physical activities, social function and causing emotionally  imbalance. Insertion of tension free vaginal tape reverses symptoms and significantly  improves all health indicators associated with patients health related quality of life. In  our study, we demonstrate that minimal invasive surgery, by using TVT-O procedure  is highly effective, in long term, in improving quality of life of women with stress urinary incontinence

Full-Text

Introduction

Urinary incontinence (UI) represents an important problem which affects women of all ages [1,2]. However the prevalence increases considerably with age and it is estimated that half of all women above 60 years old have some form of UI [3,4]. The most common subtype of UI is Stress Urinary Incontinence (SUI) which accounts for up to 80% of all cases and is defined as the complaint of involuntary leakage during effort, exertion, sneezing, coughing, exercising, or any other condition that increases the intra-abdominal pressure [5]. SUI has great impact on womens quality of life and adversely affects their physical, mental and social wellbeing [6]. While pharmacological approach is associated with low cure rates, troublesome side effects and long term recurrences, surgery represents a feasible and high effective solution [7]. Over the last century, several techniques have been proposed and applied, with satisfactory treating rates [8].

However, introduction of tension-free vaginal tapes procedures since 1995 when it was first described by Ulmsten et al more than 20 years ago, constituted a revolution in the rapidly changing field of female incontinence treatment [9]. Nowadays, minimally invasive processes applying midurethral tension- free slings are regarded as a possibly new gold standard for treatment of SUI [10]. The use of transobturator route to apply tension-free vaginal tape (TVT-O) was first described by Delorme et al. In 2001 as a new method of inserting the tape which passes through the obturator foramen, thus theoretically avoiding some of the complications such as bladder perforation [11]. In the TVTO technique the needle is passed in a reverse route, in from vaginal incision and out through the obturator foramen (inside-out) and offers cures rates exceeding 90%, fewer severe and moderate complications, less operation time and less recurrent rates [12-16]. Health related quality of life (HRQoL) is a quantitative measurement of subjective perception of patients health status, encompassing physical, functional, psychological, emotional and social aspects associated with their disease or its treatment [17]. The aim of our study was to evaluate the long term effect of TVT-O procedure on HRQoL in patients suffering by SUI.

Methods

In this prospective study were recruited women with urodynamic confirmed diagnosis of SUI that underwent TVT-O procedure. Exclusion criteria were pelvic organ prolapse, urogynecological malignancy, urinary tract infection, previous surgery for urinary incontinence and predominant urgency incontinence. Patients with major voiding dysfunction specified as an abnormal flow as maximum urinary flow rate <10 mL/s or residual urinary volume of >150 mL were also excluded. In all women HRQoL was evaluated preoperatively and 60 months postoperatively. The validated Greek versions the Medical Outcomes Study 36-item Short Form Health Survey (SF-36), with statistically confirmed sensitivity and reliability were used was used to measure HRQoL [18]. All women were evaluated using SF-36 preoperatively and after 60 months postoperatively. The SF-36 represents a multi-purpose, health self-survey consisted of 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference- based health utility index. Those scales represent vital parts patients life, which are impaired by his health as are uniquely recognized and mentioned. Those health indications are: Physical Function (Pf), Role Physical (rp), Bodily Pain (bp), General Health (gh), Vitality (vt), Social Function (sf), Role Emotional (re) and Mental Health (mh) [19,20]. The eight scales form two distinct higher- ordered clusters due to the physical and mental health variance that they have in common [21]. On all scales, higher results indicate better subjective health. For each SF36 dimension, item scores were transformed on a 0–100 (worst to best possible health state) scale [22]. Chi-square analysis and independent-sample t test were used and P-value < .05 was considered statistically significant for all comparisons. Internal consistency both preoperatively and postoperatively for each scale was evaluated by using Cronbachs alpha. Statistical analysis was performed with SPSS Statistics 20 (IBM, Armonk, NY, USA). The study was approved by the local ethics committee.

Result

A total of 102 women that underwent TVT-O surgical procedure for treatment of SUI and accepted to enroll in this study were included. Success rate of reversing SUI was 96% postoperatively, falling to 89% in 60 months. Compliance rate was as high as 91% in 5 years period. Complication rates were at 2,9%, as two women had urethra injury and another one had persistent pain, but didnt statistically affect outcome. The mean age was 55.8 SD ± 8.9 years, ranging from 37 to 81 years. 72% of the women were married and 28% were single. Seventy seven percent of patients had completed secondary education while thirty three percent of women had postsecondary education. Though, neither education level nor family status had a significant association with any individual scales in our study. SUI had significant impact on all scales of SF-36, with the exception of bodily pain, as has been recorded preoperatively. Most impaired was physical function, recording the lowest score among physical health parameters (36,58), demonstrating limitations in physical activities because of incontinence. Among mental healths scales, highly impaired were social function and role emotional scales recording score 29,45 and 28,28 accordingly. No adverse effect of the disease was mentioned on bodily pain scale and high score was recorded (86,98). Moreover, as expected, no significant improvement was recorded in painful measurements postoperatively. Conversely, a statistically important improvement in all other health scales was recorded 60 months following TVT- placement (p<0.05). Highest scores after long term follow up were recorded in physical function, role emotional and vitality scales. The largest improvement among all health scales was recorded in physical function reaching to 79,2, followed by social function and role emotional [Figure 1].

Preoperative and postoperative (60 months) comparison of patients quality of life (sf-36)

Figure 1: Preoperative and postoperative (60 months) comparison of patients quality of life (sf-36). Pf: Physical Function, rp: Role Physical, bp: Bodily Pain, gh: General Health, vt: Vitality, sf: Social Function, re: Role Emotional, mh: Mental Health.

Discussion

As SUI considerably affects womens daily activities, several surgical efforts had been made over the last 100 years in order to eliminate the problem, including but not limited to procedures such as Kelly plication, Pereyra, Marshall- Marchetti- Krantz, Burch colposuspension and urethropexy [23-25]. Those techniques despite their adequate success rates in reversing leakage, were associated with long learning curve, long operation times and high complication rates including high proportion of severe. Introduction of minimally invasive techniques with the application of tension-free vaginal tapes has largely replaced those surgical approaches [26]. Among tension-free vaginal tapes, TVT-O placement, through the obturator foramina, has the substantial advantage of avoiding the pelvis. In fact TVT-O has been proved a safe approach with high cure rate ranging from 80% to 100% and long-term success rate of 80% -95%, while offers low overall complication rates. Success rates in our study were in accordance with those data [27-30]. Most important complications that may reverse operations benefits and patients satisfaction, include injury to the structures of surrounding tissues such bladder, urethra or bowel, entrapment or damage of nerves, inability or urgency to void and persistent pain [31]. However, in our study, complication rates were too low to obtain statistically signif¬icant differences. SUI has been strongly associated with lower quality of life [32,33]. In fact women try to reduce their physical activities in order to avoid any situation that could increase intra-abdominal pressure and create urine leakage. This has impact on their daily activities and work. Moreover, due to the unpredictable and embarrassing symptomatology of SUI, women tend to isolate themselves and avoid socializing.

As a consequence of their physical problems and limitations, womens mental health is noteworthy impaired, usually complicated by depression and all those factors lead to limitations in womens usual role in family, working and social life [34]. In fact, in our study both physical and mental health dimensions were remarkable impaired by SUIs symptoms in consistence with previous studies [35]. TVT-O procedure has been demonstrated to improve SUI and as incontinence is reversed and symptomatology is eliminated, there is a significant improvement in womens HRQoL [36-38]. However, there are several restrictions in evaluating the effect of TVT-O in womens quality of life. Several short term (6 months to 1 year) evaluations have been performed and demonstrated significant improvement in HRQoL [39, 40]. Nevertheless, there are only limited data regarding long term quality of life evaluation following TVT-O procedure [41,42]. In addition we used the SF-36 to evaluate multilevel effects in HRQoL and benefit of its applicability to patients over a range of ages and with varying types and severities of SUI.

In physical dimension of health, the most noteworthy improvement was in patients physical function, as women eradicate their self-forced limitations in their physical activities. In addition, they feel capable of regaining their role as vital part of their family, work and society that were previously starkly impaired because of their inconsistence. Partially but definitely not worthless, previous beneficial effect on patients role, is due to womens higher energy level and less fatigue demonstrated. The only health indicator, in which no significant alterations were recorder, was body pain. This is totally expectable as SUI is not associated with any painful symptomatology. In mental dimension of womens health, improvement was as significant important as was in physical health. Actually, the improvement was almost equal in both physical and mental dimensions, demonstrating the multilevel impairment that SUI brings and respectively how capable TVT-O procedure is in reversing those problems. Depression, anxiety and emotional distress affect womens quality of life. However postoperatively women are more optimistic regarding their health status and emotionally and mentally more balanced. Women recover their unique roles in family, work and society. In fact regaining their social role is of significant importance as has been confirmed by our study. Social function recorded the lowest score among mental scales and the second in total demonstrating SUI adverse effect in womens social quality of life. Womens anxiety and fear of involuntary leakage even during laughing, makes them either avoiding social contacts and events, or adopting behavioral changes. However, this way their social life is severely downgraded. Nevertheless, minimal invasive techniques such implication of TVT-O, eliminates those multiple negative effects. In fact, in our study after surgery social function was restored recording one of the highest scores. Moreover, in this health indicator was recorded the second largest difference, before and after surgery, demonstrating the important role that social function has in womens quality of life. In summary, our study demonstrates that all health indicators of both physical and mental health are significantly improved by using TVT-O procedure, especially remarkably in the domains of physical and social functioning and benefits are present after 60 months.

Conclusion

Stress urinary incontinence significantly downgrades health- related quality of life, adversely affecting womens physical and mental health and impairing their personal and social life. TVT-O procedure represents minimal invasive techniques which reverse incontinence and is highly effective in considerably improving quality of life at long term.

References

1.    Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, et al. (2010) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. International urogynecology journal. 21:5-26.
2.   Wehrberger C, Temml C, Ponholzer A, Madersbacher S (2006) Incidence and remission of female urinary incontinence over 6.5 years: analysis of a health screening project. European urology 50:327-332.
3.   Minassian  VA,  Stewart  WF,  Wood  GC  (2008)  Urinary  incontinence  in women: variation in prevalence estimates and risk factors. Obstet Gynecol 111: 324-331.
4.   Bedretdinova D, Fritel X, Panjo H, Ringa V (2016) Prevalence of Female Urinary  Incontinence  in  the  General  Population  According  to  Different Definitions and Study Designs. Eur Urol 69: 256-264.
5.   Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourology and urodynamics 21:167-178.
6.   Cooper J, Annappa M, Quigley A, Dracocardos D, Bondili A, et al. (2015) Prevalence of female urinary incontinence and its impact on quality of life in a cluster population in the United Kingdom (UK): a community survey. Primary health care research and development 16:377-382.
7.   Basu M, Duckett JR (2009) Update on duloxetine for the management of stress urinary incontinence. Clin Interv Aging 4: 25-30.
8.   Park  GS,  Miller  EJ,  Jr.  (1988)  Surgical  treatment  of  stress  urinary incontinence:  a  comparison  of  the  Kelly  plication,  Marshall-Marchetti-Krantz, and Pereyra procedures. Obstetrics and gynecology 71:575-579.
9.   Ulmsten  U,  Henriksson  L,  Johnson  P,  Varhos  G  (1996)  An  ambulatory surgical  procedure  under  local  anesthesia  for  treatment  of  female urinary incontinence. International urogynecology journal and pelvic floor dysfunction 7:81-85.
10.   Latthe  PM,  Singh  P,  Foon  R,  Toozs-Hobson  P  (2010)  Two  routes  of transobturator  tape  procedures  in  stress  urinary  incontinence:  a  meta-analysis with direct and indirect comparison of randomized trials. BJU Int 106: 68-76.
11.   Delorme  E  (2001)  Transobturator  urethral  suspension:  mini-invasive procedure  in  the  treatment  of  stress  urinary  incontinence  in  women. Progres en urologie : journal de l’Association francaise d’urologie et de la Societe francaise d’urologie. 11:1306-1313.
12.   Wang  AC,  Lin  YH,  Tseng  LH,  Chih  SY,  Lee  CJ  (2006)  Prospective randomized  comparison  of  transobturator  suburethral  sling  (Monarc) vs  suprapubic  arc  (Sparc)  sling  procedures  for  female  urodynamic stress  incontinence.  International  urogynecology  journal  and  pelvic  floor dysfunction 17:439-443.
13.   Costantini E, Kocjancic E, Lazzeri M, Giannantoni A, Zucchi A, et al. (2015) Long-term efficacy of the trans-obturator and retropubic mid-urethral slings for  stress  urinary  incontinence:  update  from  a  randomized  clinical  trial. World J Urol .
14.   de Leval J (2003) Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 44: 724-730.
15.   Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, et al. (2010) Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med 362: 2066-2076.
16.   Zullo MA, Plotti F, Calcagno M, Marullo E, Palaia I, Bellati F, et al. (2007) One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral  tape  from  inside  to  outside  (TVT-O)  for  surgical  treatment of  female  stress  urinary  incontinence:  a  prospective  randomised  trial. European urology. 51:1376-1382.
17.   Guyatt GH, Feeny DH, Patrick DL (1993) Measuring health-related quality of life. Ann Intern Med 118: 622-629.
18.   Pappa E, Kontodimopoulos N, Niakas D (2005) Validating and norming of the Greek SF-36 Health Survey. Qual Life Res 14: 1433-1438.
19.   Ware JE Jr., Gandek B, Kosinski M, Aaronson NK, Apolone G, Brazier J, et al. (1998) The equivalence of SF-36 summary health scores estimated using standard and country-specific algorithms in 10 countries: results from the  IQOLA  Project.  International  Quality  of  Life  Assessment.  Journal  of clinical epidemiology. 51:1167-1170.
20.   Martin M, Kosinski M, Bjorner JB, Ware JE, Jr., Maclean R, et al., (2007) Item response theory methods can improve the measurement of physical function by combining the modified health assessment questionnaire and the SF-36 physical function scale. Quality of life research: an international journal of quality of life aspects of treatment, care and rehabilitation 16:647-660.
21.   Gandek  B,  Sinclair  SJ,  Kosinski  M,  Ware  JE  Jr  (2004)  Psychometric evaluation of the SF-36 health survey in Medicare managed care. Health Care Financ Rev 25: 5-25.
22.   Ware JE Jr., Kosinski M, Bayliss MS, McHorney CA, Rogers WH, et al. (1995) Comparison of methods for the scoring and statistical analysis of SF-36 health profile and summary measures: summary of results from the Medical Outcomes Study. Medical care. 33(4 Suppl):AS264-AS279.
23.   Lapitan MC, Cody JD (2012) Open retropubic colposuspension for urinary incontinence  in  women.  The  Cochrane  database  of  systematic  reviews 6:CD002912.
24.   Demirci F, Yildirim U, Demirci E, Ayas S, Arioglu P, et al. (2002) Ten-year results of Marshall Marchetti Krantz and anterior colporraphy procedures. Aust N Z J Obstet Gynaecol 42: 513-514.
25.   Brubaker  LT,  Sand  PK  (1988)  Surgical  treatment  of  stress  urinary incontinence:  a  comparison  of  the  Kelly  plication,  Marshall-Marchetti-Krantz, and Pereyra procedures. Obstet Gynecol 72: 820-21.
26.   Ward KL, Hilton P; UK and Ireland TVT Trial Group (2008) Tension-free vaginal  tape  versus  colposuspension  for  primary  urodynamic  stress incontinence: 5-year follow up. BJOG 115: 226-233.
27.   Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C (2013) Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. International urogynecology journal 24:1265-129.
28.   Novara G, Ficarra V, Boscolo-Berto R, Secco S, Cavalleri S, et al. (2007) Tension-free midurethral slings in the treatment of female stress urinary incontinence:  a  systematic  review  and  meta-analysis  of  randomized controlled trials of effectiveness. Eur Urol 52: 663-678.
29.   ElSheemy MS, Fathy H, Hussein HA, Elsergany R, Hussein EA (2015) Surgeon-tailored  polypropylene  mesh  as  a  tension-free  vaginal  tape-obturator versus original TVT-O for the treatment of female stress urinary incontinence: a long-term comparative study. International urogynecology journal 6:1533-1540.
30.   Tincello DG, Botha T, Grier D, Jones P, Subramanian D, et al. (2011) The  TVT  Worldwide  Observational  Registry  for  Long-Term  Data:  safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women. J Urol 186: 2310-2315.
31.   Jones R, Abrams P, Hilton P, Ward K, Drake M (2010) Risk of tape-related complications after TVT is at least 4%. Neurourol Urodyn 29: 40-41.
32.   Riss P, Karg J (2011) Quality of life and urinary incontinence in women. Maturitas 68: 137-142.
33.   Goldacre MJ, Abisgold JD, Yeates DG, Voss S, Seagroatt V (2007) Self-harm and depression in women with urinary incontinence: a record-linkage study. BJU Int 99: 601-605.
34.   Coyne KS, Kvasz M, Ireland AM, Milsom I, Kopp ZS, et al., (2012) Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States. European urology 61:88-95.
35.   Coyne KS, Zhou Z, Thompson C, Versi E (2003) The impact on health-related quality of life of stress, urge and mixed urinary incontinence. BJU Int 92: 731-735.
36.   Naumann G, Steetskamp J, Meyer M, Laterza R, Skala C, et al. (2013) Changes  in  sexual  function  and  quality  of  life  after  single-incision  mid-urethral sling for treatment of female stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol 168: 231-235.
37.   Abdel-Fattah  M,  Mostafa  A,  Familusi  A,  Ramsay  I,  N’Dow  J  (2012) Prospective  randomised  controlled  trial  of  transobturator  tapes  in management  of  urodynamic  stress  incontinence  in  women:  3-year outcomes from the Evaluation of Transobturator Tapes study. European urology 62:843-851.
38.   Fan Y, Huang Z, Yu D (2015) Incontinence-specific quality of life measures used in trials of sling procedures for female stress urinary incontinence: a meta-analysis. International urology and nephrology 47: 1277-1295.
39.   Scheiner DA, Betschart C, Wiederkehr S, Seifert B, Fink D, et al., (2012) Twelve  months  effect  on  voiding  function  of  retropubic  compared  with outside-in  and  inside-out  transobturator  midurethral  slings.  International urogynecology journal 23:197-206.
40.   Maslow  K,  Gupta  C,  Klippenstein  P,  Girouard  L  (2014)  Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence. International urogynecology journal 25: 909-914.
41.   Laurikainen E, Valpas A, Aukee P, Kivela A, Rinne K, et al. (2014) Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. European urology 65:1109-1114.
42.   Tommaselli GA, D’Afiero A, Di Carlo C, Formisano C, Fabozzi A, et al., (2015) Tension-free vaginal tape-obturator and tension-free vaginal tape-Secur  for  the  treatment  of  stress  urinary  incontinence:  a  5-year  follow-up  randomized  study.  European  journal  of  obstetrics,  gynecology,  and reproductive biology. 185:151-155.

*Corresponding author

 Athanasios Farfaras MD, Ph.D, M.Sc, A’ department of obstetrics and Gynecology, “Helena Venizelou” Maternal hospital, Helena Venizelou sq 2, PC: 11521, Athens, Greece

Citation

Farfaras A, AntoniouS, SkolarikosP(2016) Long Term Quality of Life after Tension-Free Vaginal Tape-Obturator Procedure in Women with Stress Urinary Incontinence. NHC 105: 21-25

Keywords

Urinary incontinence, Stress urinary incontinence, Transobturatorvaginal tape, Quality of life, Physical health; Mental health


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