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Obstetrics & Gynecology 2002;100:518-524
© 2002 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Tension-Free Vaginal Tape: A Quality-of-Life Assessment

Brett J. Vassallo, MD, Steven D. Kleeman, MD, Jeffrey L. Segal, MD, Peggy Walsh, RN and Mickey M. Karram, MD

From the Good Samaritan Hospital, Seton Center for Advanced Obstetrics & Gynecology, Cincinnati, Ohio.

Address reprint requests to: Brett J. Vassallo, MD, Good Samaritan Hospital, Seton Center for Advanced Obstetrics and Gynecology, 375 Dixmyth Avenue, Cincinnati, OH 45220; E-mail: brettv{at}earthlink.net.


   ABSTRACT
TOP
ABSTRACT
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE: To assess whether tension-free vaginal tape (TVT) results in significant improvements in urinary incontinence and its effect on patients’ quality of life (QOL) utilizing two validated questionnaires.

METHODS: One hundred sixty-two tension-free vaginal tape procedures were performed at two sites between October 1998 and January 2001. All patients were requested to complete the Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6) as part of their preoperative assessment. History, physical, and demographic data were also collected. All subjects underwent subtracted cystometry and urethral function tests prior to surgery. A combination of mail and phone follow-up was used to obtain postoperative IIQ-7 and UDI-6 scores in October 2001. Data were analyzed with the Wilcoxon matched-pairs signed-ranks test.

RESULTS: One hundred fifty-one patients completed the pre- and postoperative quality-of-life forms and were included in the analysis. Mean follow-up was 22.1 months (range 6.1–49.8). There were significant improvements in postoperative scores for both the IIQ-7 and the UDI-6 (P < .001). Significant improvements were also seen in subscales measuring urge symptoms, stress incontinence symptoms, and symptoms of voiding dysfunction. These improvements were consistent, regardless of type or severity of stress incontinence.

CONCLUSION: The IIQ-7 and UDI-6 are validated tools that can be used to provide some objective evidence for the impact of urinary incontinence on patients’ lives. Utilizing these two validated quality-of-life tools we show that tension-free vaginal tape results in significant improvement in patient quality of life and symptoms of urgency, stress incontinence, and voiding dysfunction.

Quality of life, as defined by Kelleher, is an abstract concept encompassing an individual’s perceived level of physical, psychological, and social well-being that is subjective and mediated by personal and cultural values.1 As such, it is influenced by personal experience, disease processes, support structures, and treatments. Several authors have pointed out that a person’s quality of life is as significant as the current status of their physical problem or disease.2–4 Furthermore, as we consider the endpoints of the treatments we employ we must realize that success is defined not only by clinical parameters, but also by physical, mental, and social well-being.5,6 Our proper care of patients demands this understanding, and clinical experience tells us that patient satisfaction requires this consideration as well.

Urinary incontinence is a common problem that has been reported to affect young women and has a prevalence rate among community-dwelling women over 65 of up to almost 50% and among women in nursing homes of 40–70%.7,8 Many of these women are electing to undergo surgical correction of their incontinence as demonstrated by Olsen et al, who found that the lifetime risk of undergoing a single operation for prolapse or incontinence by age 80 was 11.1% and reoperation occurred in almost 30%.9 With so many procedures performed for these complaints and such a high rate of dissatisfaction requiring reoperation, it becomes paramount that we carefully consider the various outcome parameters we have to measure patient satisfaction. Objective clinical tests still clearly play a role in assessing patients postoperatively, but subjective concerns such as quality of life are extremely important in determining outcomes of various procedures for pelvic floor dysfunction. Moreover, any tools at our disposal that objectify or reduce the opportunity for subjective error can simplify and play a vital role in our assessment of patients.

Outcome studies of surgical procedures have been carried out for many decades. Their shortcomings are very apparent–vague subjective questionnaires that simply query as to cure, improved, or worsened symptoms are clearly inadequate. In response to this inadequacy, various clinical tools have been developed that permit the collection of more specific data. One of these methods is a symptom inventory, which asks women to document the presence or severity of distress for symptoms associated with urinary incontinence. This instrument has the advantages of being inexpensive, simple, noninvasive, and potentially self-administered. Various impact and health profiles have been created which attempt to measure life impact in the evaluation of therapeutic efficacy. Unfortunately, these profiles are very general and often inadequately translate to symptoms of urinary tract dysfunction. To address these short-comings, Wyman et al and later Shumaker et al, developed a combination life-impact assessment specific to urinary incontinence, the Incontinence Impact Questionnaire (IIQ), and a specific symptom inventory, the Urogenital Distress Inventory (UDI).10,11 These instruments are composed of 30 and 19 questions, respectively, and although validated and shown to be effective in evaluating treatment efficacy, have proven to be impractical due to the length of time required to complete them.11 In 1995 Uebersax et al presented short versions of the IIQ and UDI composed of 7 and 6 questions, respectively, the IIQ-7 and the UDI-6 (Appendix AGo and Appendix BGo). These short forms have also been validated and show a high degree of correlation to the longer forms.12 The UDI-6 can also be broken into three subscales: irritative symptoms (items 1 & 2), stress symptoms (items 3 & 4), and obstructive/discomfort or voiding difficulty symptoms (items 5 & 6). Consideration of these subscales can be a useful way of critiquing a subject’s status after treatment. For example, an incontinence operation may result in a good stress incontinence symptom subscale score, but result in a poor irritative symptom score. This subtlety can be overlooked if only the general UDI score is considered.


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  		Appendix A. Short Form of the Incontinence Impact Questionnaire
 

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  		Appendix B. Short Form of the Urinary Distress Inventory
 
Although not specifically described in the literature, one manner in which these instruments can be used is to have a subject complete the questionnaires prior to treatment and then at various times during and after treatment to assess her progress. This gives the caregiver a baseline status prior to intervention and then permits comparisons of scores throughout the patient’s care. This internal comparison is really the only valid means by which conclusions can be drawn as to changes in scores with treatment as the scores themselves are based on each individual’s subjective responses.

The tension-free vaginal tape (TVT) is a relatively new procedure to correct stress incontinence. Recent data indicate that its efficacy and untoward effects are similar to other commonly performed anti-incontinence procedures such as retropubic urethropexy and suburethral sling procedures.13 The objective of this study is to assess whether TVT results in significant improvements in symptoms of urinary incontinence and patients’ quality of life utilizing two validated questionnaires.


   MATERIALS AND METHODS
TOP
ABSTRACT
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
The study population consisted of all women from the senior author’s (MMK) practice who underwent the TVT procedure at two sites between October 1998 and January 2001. All patients were requested to complete the short forms of the IIQ and the UDI. The forms were mailed to the patients with instructions on how to complete the forms prior to their first visit and reviewed at the time of the first visit. If the patient neglected to complete at home or bring the quality-of-life form to the office, an additional form was given to her in the office to complete. At the time of the first visit a thorough history and physical examination was undertaken including an assessment of pelvic support, urinalysis, and simple cystometry to screen for urge and stress incontinence symptoms. Various demographic data were collected at this time and are reported in Table 1Go. During the course of their workup, patients who elected surgical treatment of their incontinence also underwent subtracted cystometry to objectively document the presence of genuine stress incontinence. Urethral function tests in the form of urethral closure pressures and valsalva leak point pressures were utilized to quantify the severity of disease and diagnose intrinsic sphincter deficiency.


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  		Table 1. Demographic Data
 
One hundred sixty-two women underwent the tension-free vaginal tape procedure during the time documented above as described by Ulmsten et al in 1996.14 These procedures were performed either alone or in conjunction with other gynecologic procedures. If performed in conjunction with other procedures we varied Ulmsten’s technique only in the use of general as opposed to local anesthesia and the use of suprapubic pressure instead of having the patient cough to adjust the tension of the tape. Details of the concomitant procedures performed are shown in Table 2Go. Institutional review board approval was obtained prior to commencing this study.


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  		Table 2. Concomitant Procedures
 
In October 2001, all 162 patients were mailed the short forms of the IIQ and UDI with a postage-paid return envelope and instructions including the specification that their answers imply the degree to which they were affected by their symptoms at the present time. All patients who did not return the completed forms were called by our research nurse (PW) and completed the forms over the phone. The research nurse was given only a list of names and phone numbers of subjects who had undergone the tension-free vaginal tape procedure. She was otherwise blinded to the subjects’ preoperative quality-of-life results, medical/surgical histories, and whether or not concomitant procedures were performed at the time of the incontinence operation. Patients were excluded from the study if follow-up was less than 6 months and if they did not complete both pre- and postoperative IIQ and UDI forms.

Scores were calculated on a scale from 0 to 100 as described by Uebersax.12 A score of 0 meant that the patient was not bothered at all by a particular symptom. A score of 100 implied the most severe degree of dissatisfaction with a particular symptom. Two general scores were calculated for the IIQ-7 and UDI-6. Then three subscale scores were calculated based on the UDI-6 to assess irritative, stress, and obstructive/discomfort symptoms. Pre- and postoperative scores were then compared using the Wilcoxon matched-pairs signed-ranks test. Each subject was her own control.

Subjects were then divided into three groups based on the type of stress incontinence they had. Anatomic incontinence was defined as genuine stress urinary incontinence with urethral hypermobility (straining Q-tip angle >= 30°) and normal urethral function (maximum urethral closure pressure > 20 cm H2O and valsalva leak point pressure < 60 cm H2O). Intrinsic sphincter deficiency (ISD) was diagnosed in any subject with genuine stress incontinence and evidence of abnormal urethral function (maximum urethral closure pressure < 20 cm H2O or valsalva leak point pressure < 60 cm H2O). Occult incontinence was defined as documentation of genuine stress incontinence only with manual reduction of pelvic organ prolapse. Pre- and postoperative scores were then compared as described above.


   RESULTS
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Of the 162 eligible patients, 1 subject did not complete the forms preoperatively, 8 could not be located, 1 declined to participate, 1 was unable to complete the postoperative forms due to end-stage Alzheimer disease, and 1 was found to be deceased. One hundred fifty-one women (93.2%) completed both preoperative and postoperative IIQ-7 and UDI-6 forms. One of the subjects who was unable to be located had completed quality of life forms at her 3-month follow-up visit and was therefore included in the final analysis.

Table 3Go depicts the mean, median, and standard deviation (SD) for the pre- and postoperative scores according to the quality-of-life tool utilized. The mean ± SD follow-up was 22.1 ± 7.1 months (range 6.1–49.8). Subscales for the UDI-6 are reported here as well. Including the subscales, we considered a total of five sets of pre-and postoperative scores (IIQ-7, UDI-6, and the three UDI-6 subscales). In all five of these sets of data the mean postoperative score was lower than the mean preoperative value. In all five cases the P value was < .001. The median postoperative score was zero for the IIQ-7, stress, and discomfort/voiding difficulty subscales.


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  		Table 3. Results of Quality-of-Life Questionnaires, All Subjects (N = 151)
 
Thirty-seven (24.5%) of the subjects underwent only the TVT procedure and did not have concomitant prolapse surgery. Pre- and postoperative IIQ, UDI, and subscale scores are presented for these subjects in Table 4Go. Similar to the overall population, this subgroup of patients showed significant improvements in postoperative scores for all categories except the discomfort/voiding difficulty subscale.


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  		Table 4. Results of Quality-of-Life Questionnaires, TVT Only (n = 37)
 
Patients were also divided into categories based on the type of stress urinary incontinence they had. This data is shown in Table 5Go. Each subject only met the criteria for one of the three groups: 122 had anatomic stress incontinence with normal urethral function, 13 had ISD, and 22 had occult stress incontinence with normal urethral function. Again, the mean postoperative scores were lower than the mean preoperative scores for all scales. Postoperative values were statistically significantly lower in all three groups for all scales with the single exception of the discomfort/voiding difficulty subscale for the ISD patients (P = .25).


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  		Table 5. Mean Quality-of-Life Scores With Subjects Divided by Type of GSUI
 

   DISCUSSION
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
As with any physical complaint, an attempt to quantify the effect of the malady on the patient’s quality of life requires the examiner to base his or her conclusions on the patient’s subjective assessment of their symptoms. Every person displays a differing degree of tolerance to a particular symptom such as urinary incontinence. Furthermore, the degree to which the improvement or worsening of symptoms is due to concomitant procedures cannot be known. Because urinary incontinence plays such a large role in the two instruments we selected, we attempted to focus on the effects of the TVT procedure itself. We cannot discount, however, that the improvement for some subjects with advanced degrees of pelvic organ prolapse and preoperative irritative bladder symptoms or voiding difficulty might be due in large part to the repair of their prolapse. Correlation of the findings in this study with other properly performed objective tests would clearly bolster our conclusions, although the statistical strength of the improvement in quality of life shown using these previously validated instruments is clearly evident. Nevertheless, postoperative assessments including standardized pelvic organ prolapse quantitation (POP-Q) exams, standing cough stress tests, and 1-hour pad testing is ongoing at this time and will be reported as part of a subsequent study. Bearing these items in mind, quality-of-life tools such as the IIQ-7 and UDI-6 can still be quite useful in assessing patients’ progress. The fact that one subject’s scores after treatment may be more dramatically changed than a different subject is buffered by the technique of using each person as her own control and thus minimizing subjective differences between different patients.

Alternatively, these instruments provide information that, in some sense, is more accurate than an objective finding such as the surgeon’s physical exam. The patient has complete control over the responses on the questionnaire, whereas the postoperative examination is subject to the surgeon’s bias toward reporting success.

One hundred fourteen of the subjects included in this study underwent concomitant procedures. From Table 2Go one can appreciate that the other procedures were almost all vaginal procedures. This fact highlights one of the advantages of the TVT procedure. It permits the surgeon to address incontinence and prolapse effectively from one approach (vaginal). The single laparotomy reported occurred in a patient in whom a general surgeon performed an extensive lysis of adhesions after we completed the TVT procedure. Although a substantially smaller portion of the entire study population, the degree of significance in improvement in the quality-of-life scores for the 37 patients who underwent the TVT procedure alone was almost identical to the study population as a whole. The only scale that did not show significant improvement (although the P value was borderline, .052) was the discomfort/voiding difficulty scale. This subscale captures many symptoms that may be attributed to prolapse. Therefore, it is not surprising that we did not see such a significant improvement here, as these subjects did not have significant pelvic organ prolapse preoperatively.

Subjective and objective cure rates in stress incontinence after the TVT procedure have been reported to be in the range of 81–96%.15–17 We had collected subjective cure, improved, and failure rates among these 151 patients as part of another study by asking them if they noted no loss of urine with coughing, sneezing, lifting, or laughing (cure); they noticed these symptoms, but less often and less severe than prior to their surgery (improved); or they felt they leaked urine to the same degree or worse than before their surgery. Ninety-six considered themselves cured, 47 felt they were improved, and only eight considered themselves the same or worse (abstract presented at 22nd annual meeting of the American Urogynecologic Society. Chicago, IL: October 25–7, 2001). Thus, 143 (94.7%) considered themselves cured or improved. Although such subjective cure rates are highly vulnerable to bias, it is notable that our quality-of-life findings were comparable. Eighty-one percent of subjects showed improved IIQ scores, 10% were unchanged, and only 9% were worse. Similarly, UDI scores were improved in 85%, unchanged in 4%, and worse in 11%. The fact that similar degrees of improvement were consistently found even when patients were subdivided into the various types of stress incontinence speaks for the versatility of this operation. The lack of statistical significance between the pre- and postoperative voiding difficulty scores among the intrinsic sphincter deficiency patients is likely due to the small sample size of this group. A power calculation was performed for this group of patients and it was determined that, at a power of 80%, the number of subjects that would have been required to show a statistically significant difference between the pre- and postoperative voiding difficulty scores was 94.

Median scores were also reported because they are less sensitive to the effect of outliers than mean scores. The reporting of the ranges of scores would have been misleading due to such outliers. For example, three patients had preop IIQ scores of 0 and three had scores of 100. Ninety-nine subjects had postop IIQ scores of 0 and only 1 had a score of 100. The ranges for both groups would be reported as 0 to 100, when clearly the pre- and postoperative means (39.3 versus 10.6) and medians (38.1 versus 0) suggest dramatic improvements in postoperative IIQ scores. This holds true even looking at the individual scores: 122 subjects had improved IIQ scores, 16 were unchanged, and 13 were worse. It is significant that enough subjects had complete resolution of their symptoms for the IIQ-7 scale and the stress and voiding difficulty subscales that the median scores on these scales were zero. Thus, more than half of the patients had complete resolution of these symptoms. It should also be kept in mind that subjects with very rare episodes of incontinence or symptoms other than incontinence itself (such as frequency or pain) will not have zero scores, yet they had significant improvement compared to their preoperative scores. Such a dramatic improvement would be necessary to achieve the degree of statistical significance we found, even among the smaller groups of intrinsic sphincter deficiency and occult incontinence patients.

One of the early criticisms of the previously published outcome data from the TVT procedure was the lack of reported untoward effects (voiding dysfunction, etc). Presumably such negative aspects of this procedure were not emphasized in light of its tremendous efficaciousness in treating stress incontinence. Our data provides a useful perspective into the small degree to which patients may trade irritative voiding symptoms for continence. The subscales from the UDI showed that 69% of women had improvement in their irritative symptoms, while 14% were unchanged and 17% were worse. Fifty-two percent had improved discomfort/voiding difficulty scores, 27% were unchanged, and 21% were worse. Our current postoperative urodynamic data is not adequate to suggest that the worsening voiding dysfunction is definitely due to the TVT procedure, but it is certainly possible. A postoperative voiding dysfunction rate of 21% puts this procedure on par with retropubic and traditional sling procedures for incontinence that have postoperative voiding dysfunction rates of approximately 22%.18,19 Because the intention of the TVT procedure is to treat stress incontinence it is not surprising that the postoperative stress subscale showed such success, with 81.4% of subjects having improved scores, and only 9.3% unchanged and 9.3% worse.

We believe this study strongly supports not only the success of the TVT procedure, but underscores the ease of utilizing such quality-of-life instruments. While there is no substitute for thoroughly counseling the patient prior to surgery, reviewing the postoperative scores can help the patient understand how she is improved and guide the physician in the treatment of unresolved or new concerns. This also emphasizes for the physician the importance of considering the patient’s quality of life during the course of her treatment.


   Footnotes
 
The authors acknowledge Kim Hasselfeld and Melissa Flake for their assistance with the statistical analysis.

PII S0029-7844(02)02119-1

Received January 24, 2002. Received in revised form March 19, 2002. Accepted April 4, 2002.


   REFERENCES
TOP
ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
1. Kelleher CJ, Cardozo LD, Toozs-Hobson PM. Quality of life and urinary incontinence. Curr Opin Obstet Gynecol 1995;7:404–8.[Medline]

2. Murawski BJ, Penman D, Schmitt M. Social support in health and illness; the concept and its measurement. Cancer Nurs 1978;1:365–71.[Medline]

3. Zyzanski SJ. Medical and social outcomes of survivors of major heart surgery. J Psychosom Res 1981;23:213–21.

4. Kaplan-DeNour A. Social adjustment of chronic dialysis patients. Am J Psychiatry 1982;139:97–100.[Abstract/Free Full Text]

5. World Health Organization. Constitution of the World Health Organization. Geneva: WHO, 1994.

6. Filbeck T, Ullrich T, Pichlmeier U, Keil HJ, Wieland WF, Roessler W. Correlation of persistent stress urinary incontinence with quality of life after suspension procedures: Is continence the only decisive postoperative criterion of success? Urology 1999;54:247–51.[Medline]

7. Herzog AR, Fultz NH. Prevalence and incidence of urinary incontinence in community-dwelling populations. J Am Geriatr Soc 1990;38:273–81.[Medline]

8. Weber AM, Walters MD. Epidemiology and social impact of urinary and fecal incontinence. In: Karram MM, Walters MD, eds. Urogynecology and reconstructive pelvic surgery. 2nd ed. St. Louis: Mosby, 1999:25.

9. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997;89:501–6.[Abstract]

10. Wyman JF, Harkins SW, Choi SC, Taylor JR, Fantl JA. Psychosocial impact of urinary incontinence in women. Obstet Gynecol 1987;70:378–81.[Abstract]

11. Shumaker SA, Wyman JF, Uebersax JS, McClish DK, Fantl JA. Health-related quality of life measures for women with urinary incontinence: The incontinence impact questionnaire and the urogenital distress inventory. Qual Life Res 1994;3:291–306.[Medline]

12. Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: The incontinence impact questionnaire and the urogenital distress inventory. Neurourol Urodyn 1995;14:131–9.[Medline]

13. Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2001;12 Suppl 2:S5–8.

14. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1996;7:81–6.[Medline]

15. Schiutz HA. Tension-free vaginal tape (TVT)–a new surgical procedure for female stress incontinence. J Obstet Gynaecol 2000;20:158–61.[Medline]

16. Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson CG, et al. A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1998;9:210–3.[Medline]

17. Wang AC, Lo TS. Tension-free vaginal tape. A minimally invasive solution to stress urinary incontinence in women. J Reprod Med 1998;43:429–34.[Medline]

18. Alcalay M, Monga A, Stanton SL. Burch colposuspension: A 10–20 year follow up. Br J Obstet Gynaecol 1995;102:740–5.[Medline]

19. Weinberger MW, Ostergard DR. Postoperative catheterization, urinary retention, and permanent voiding dysfunction after polytetrafluoroethylene suburethral sling placement. Obstet Gynecol 1996;87:50–4.[Abstract]




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