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Prevalence of Persistent and De Novo Overactive Bladder Symptoms After the Tension-Free Vaginal Tape

From the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Good Samaritan Hospital, Cincinnati, Ohio.

Address reprint requests to: Jeffrey L. Segal, MD, Saint Barnabas Medical Center, Suite 3148, 94 Old Short Hills Road, Livingston, NJ 07039; e-mail: Jsegel{at}sbhcs.com.

	ABSTRACT

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
OBJECTIVE: The purpose of this study was to assess 1) the proportion of de novo urge incontinence and overactive bladder symptoms after a tension-free vaginal tape (TVT), and 2) the natural history of preoperative urge incontinence and overactive bladder symptoms after a TVT.

METHODS: A chart review was performed on all patients who underwent a TVT without concomitant procedures from November 1998 to November 2002. Preoperative and postoperative stress and mixed urinary incontinence symptoms as well as overactive bladder symptoms were assessed subjectively, as was the use of anticholinergics to treat overactive bladder symptoms. Two preoperative and postoperative validated quality-of-life questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6), were also compared.

RESULTS: Ninety-eight patients were included in the study. Postoperatively, de novo urge incontinence symptoms developed in 9.1%, de novo overactive bladder symptoms developed in 4.3%, and 8.7% started taking anticholinergics for the first time. After a TVT, the urge component resolved in 63.1% of those with preoperative symptoms of mixed incontinence, overactive bladder symptoms resolved in 57.3% of those with preoperative overactive bladder symptoms, and 57.7% of those who used anticholinergics preoperatively no longer needed to do so. There was also a statistically significant improvement in comparing the preoperative and postoperative IIQ-7 and UDI-6 scores.

CONCLUSION: The proportion of patients in whom de novo overactive bladder or urge incontinence symptoms developed postoperatively is low, and approximately 57% of patients with preoperative overactive bladder symptoms can expect resolution of these symptoms after a TVT.

Previous studies have shown that 50–60% of patients with mixed incontinence are cured of their urge incontinence after surgical support of the bladder neck.⁴ McGuire et al⁵ and Fulford et al⁶ both reported resolution of urge incontinence in 69% after a pubovaginal sling, whereas 74% of patients in Morgan et al's study⁷ had resolution of their urge component. It is unknown, however, what effect the TVT has on the urge component of patients with mixed incontinence.

Additionally, de novo urge incontinence and de novo overactive bladder symptoms are known risk factors of anti-incontinence procedures. De novo detrusor overactivity is reported to occur in 0–30% of patients after anti-incontinence surgery.⁸ The incidence of de novo detrusor overactivity has been reported in 5–32% of patients after a retropubic colposuspension,^9–11 5–11% after a needle suspension,^12,13 and 3–24% after suburethral sling procedures.¹⁴ Two studies, however, have shown that irritative bladder symptoms such as urgency, frequency, nocturia, and dysuria develop in up to 50% of patients who have undergone suburethral sling procedures.^15,16

The TVT is a relatively new procedure used to treat stress urinary incontinence that differs from traditional suburethral slings. It is placed without tension at the level of the midurethra rather than at the bladder neck, it has no points of fixation, and there is no plane of dissection after the vaginal wall incision. It is thought that because the TVT is placed without tension at the level of the midurethra, it should result in a lower rate of voiding dysfunction, de novo urge incontinence, and overactive bladder symptoms. Previous studies, however, have shown that there still is associated voiding dysfunction after a TVT (ranging from 4.3% to 10%),^17,18 as well as de novo overactivity (ranging from 6% to 15%).^19,20 To date, few studies have evaluated the effect of the TVT on patients with mixed symptoms, as well as its effect on overactive bladder symptoms.

The purpose of this study was to assess 1) the proportion of de novo urge incontinence and overactive bladder symptoms after a TVT, and 2) the natural history of preoperative urge incontinence and overactive bladder symptoms in patients who have undergone a TVT procedure.

	MATERIALS AND METHODS

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
A chart review was performed on all patients who underwent a TVT suburethral sling from November 1998, the time when the TVT procedure was first used in the senior author's practice, to November 2002. To minimize the confounding effect of other causes of de novo urge incontinence or overactive bladder symptoms, those who had concomitant procedures performed were excluded, as were those with follow-up times of less than 6 weeks. This was a prevalence study in which the patients were representative of all patients in the senior author's practice who had this procedure done from the time the TVT was first introduced to the practice throughout its first 4 years of use (1998–2002). The sample size was determined by evaluating all of the population of interest who met the previously described inclusion criteria during the specified period. The study was approved by the hospital Institutional Review Board at its inception.

All patients presented with symptoms of urinary incontinence and had a diagnosis of genuine stress urinary incontinence made by a subtracted cystometric study. A standardized history was obtained at the initial office visit where patients were asked if they reported stress incontinence, urge incontinence, or both. Patients were also asked if they experienced urinary urgency, frequency, and nocturia. Preoperatively, all patients were asked to complete 2 validated quality-of-life questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6). The UDI-6 was divided into 3 subscales: irritative symptoms (items 1 and 2), stress symptoms (items 3 and 4), and obstructive/discomfort symptoms (items 5 and 6).

At the initial visit, a standardized examination was performed to assess vaginal support. Bladder neck support was assessed by using a cotton-tipped swab test ("Q-Tip Test"). Simple uroflowmetry and simple office cystometry were also performed at this time. On a subsequent visit, all patients had a multichannel urodynamic study consisting of subtracted filling cystometry, measurement of maximum urethral closure pressures and leak point pressures, and a pressure flow study. The techniques of these tests have been previously described.^21,22

The TVT suburethral sling as described by Ulmsten et al²³ was performed on all patients by using local anesthesia with intravenous sedation. The procedure remained unchanged over the study period. Patients were evaluated 2 and 6 weeks postoperatively and then at 3 months and 1 year. If patients had overactive bladder symptoms and had a normal postvoid residual and a negative dipstick urinalysis, they were offered a trial of anticholinergics. At 3 months postoperatively, each patient was also asked to complete the same quality-of-life questionnaires.

Urge incontinence and overactive bladder symptoms were compared in several ways. We compared overactive bladder symptoms preoperatively and postoperatively to estimate the proportion of patients in whom de novo symptoms developed postoperatively, as well the proportion who had resolution of these symptoms after a TVT. We made a similar comparison to assess the proportion of de novo urge incontinence symptoms and the natural history of urge incontinence in patients with preoperative symptoms of mixed incontinence after a TVT. We also compared preoperative and postoperative use of anticholinergics to determine the proportion of patients who no longer required anticholinergics after a TVT and the proportion who started to take an anticholinergic for the first time in the postoperative period. We then compared preoperative and postoperative quality-of-life scores, including the irritative subscale.

Definitions of lower urinary tract symptoms and conditions that were used in the study are described by the International Continence Society.²⁴ Intrinsic sphincter deficiency was defined by a Valsalva leak point pressure below 60 cm H₂O or a maximum urethral closure pressure below 20 cm H₂O. Failure was defined by the need for an additional anti-incontinence procedure after the TVT. Postoperative voiding dysfunction was defined by obstructive or irritative symptoms after the TVT requiring revision, urethral dilation, or the need to perform prolonged intermittent self-catheterization defined as longer than 6 weeks.

A paired t test analysis was used to compare the preoperative and postoperative general scores for the IIQ-7 and UDI-6, as well as the 3 subscale scores. This analysis was done to compare whether the preoperative quality-of-life scores differed significantly from the postoperative quality-of-life scores for patients undergoing a TVT. Additionally, preoperative and postoperative quality-of-life scores were compared to determine the percentage of patients whose scores improved, worsened, or remained unchanged. Odds ratios for postoperative overactive bladder symptoms requiring use of an anticholinergic were also calculated. Possible risk factors included postmenopausal status, use of hormone-replacement therapy, mean parity of more than 2.63, mean body mass index of more than 29.74, prior anti-incontinence surgery, maximum mean bladder capacity of less than 395 mL, Valsalva leak point pressure below 60 cm H₂0, maximum urethral closure pressure below 20 cm H₂O, presence of bladder contractions either on a simple or subtracted cystometrogram, preoperative urge urinary incontinence symptoms, preoperative overactive bladder symptoms, and intraoperative bladder perforation.

	RESULTS

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
Ninety-eight patients who underwent only a TVT procedure from November 1998 to November 2002 were included in the study. There were an additional 355 patients who were excluded because of concomitant surgery performed at the time of their TVT, and 23 patients were excluded because of less than 6 weeks of follow-up data. Based on subjective complaints, patients were categorized as having stress incontinence (n = 33) or mixed incontinence (n = 65). Demographic data as categorized by these symptoms are listed in Table 1.

There were 17 patients who had evidence of intrinsic sphincter deficiency: 4 with preoperative symptoms of stress incontinence and 13 with preoperative symptoms of mixed incontinence. A Valsalva leak point pressure less than 60 cm H₂O diagnosed 12 cases, and 5 were diagnosed by a urethral closure pressure less than 20 cm H₂O. The mean maximum bladder capacity and standard deviation was 407.5 ± 103.7 mL for the stress group and 389.7 ± 125.2 mL for the mixed group (P = .897). Only 6 patients were diagnosed preoperatively in patients with an involuntary bladder contraction during filling cystometry, despite the fact that 65 patients reported urinary urge incontinence preoperatively.

The effect of the TVT on urge incontinence and overactive bladder symptoms was then analyzed based on preoperative symptoms (Table 2). Of the 33 patients with pure stress symptoms preoperatively, de novo urge incontinence symptoms developed postoperatively in 3 patients (9.1%), 1 of whom was started on anticholinergics. Of the 65 patients with mixed symptoms of urinary incontinence preoperatively, the urge component resolved in 63.1% postoperatively. Interestingly, 2 patients in this group initially presented with symptoms of only urge incontinence but had a diagnosis of stress incontinence by subtracted cystometry. Postoperatively, the symptom of urge incontinence persisted in both of these patients and anticholinergics were prescribed. There were a total of 33 patients with postoperative overactive bladder symptoms. Of these, 3.0% were de novo and 97.0% were persistent. There were 75 patients who had preoperative overactive bladder symptoms, and this resolved in 57.3% after a TVT.

Table 2 also reports the effects of the TVT on overactive bladder symptoms based on preoperative and postoperative anticholinergic use. A total of 52 patients used anticholinergics preoperatively. Of these, 30 (57.7%) no longer required anticholinergics postoperatively. Forty-six did not use preoperative anticholinergics, and of these, 4 (8.7%) used them for the first time postoperatively.

There were a total of 10 bladder perforations in 8 patients (8.2%); 3 of these patients had postoperative overactive bladder symptoms, and all 3 patients were started on an anticholinergic. Six patients (6.1%) had voiding dysfunction requiring either prolonged intermittent self-catheterization longer than 6 weeks (2 patients), urethral dilation (2 patients), or revision of the TVT (2 patients); all had postoperative symptoms of urge incontinence. The TVT failed to effectively treat stress incontinence in 4 patients (4.1%); 2 had a subsequent retropubic urethropexy, and 2 had transurethral injections. A differential effect with respect to procedure success or failure and the resolution, persistence, or development of overactive bladder symptoms was not noted.

The overall median preoperative and postoperative quality-of-life scores are shown in Table 3, and the same scores categorized by patient's preoperative symptoms are shown in Table 4. Table 5 illustrates the percentage of patients who had improvement, worsening, or no change in their quality-of-life scores after a TVT. A total of 75 of 98 patients (76.5%) completed both preoperative and postoperative scores. There was a statistically significant improvement in the overall IIQ-7 and UDI-6 scores and in the 3 UDI-6 subscales scores after the TVT. Ninety-one percent of patients had an overall improvement in their IIQ-7 score, and 89.3% of patients had an overall improvement in their UDI-6 score and in the 3 subscale scores.

Of all the variables assessed as possible risk factors for postoperative overactive bladder symptoms requiring an anticholinergic, as shown in Table 6, only 1 was found to be statistically significant. Those who had a prior anti-incontinence surgery were more than 8 times more likely to have postoperative overactive bladder symptoms requiring an anticholinergic after a TVT (odds ratio 8.200; 95% confidence interval 1.32, 13.33; P = .046). The odds ratios of preoperative urge incontinence symptoms, overactive bladder symptoms, and the presence of preoperative bladder contractions were 3.400, 3.228, and 1.500, respectively, but none were statistically significant.

	DISCUSSION

TOP ABSTRACT MATERIALS AND METHODS RESULTS DISCUSSION REFERENCES

 
Several theories have been hypothesized to explain why urge symptoms may improve after an anti-incontinence procedure. One is that increased abdominal pressure results in stretching of the pelvic nerves, and that this triggers an involuntary bladder contraction. The pubovaginal sling stabilizes the bladder neck and thereby prevents this stretching from occurring.²⁵ A similar theory is that detrusor overactivity is caused by a weak urethral sphincter mechanism, resulting in funneling of the proximal urethra. When intraabdominal pressure is increased, urine enters the proximal urethra, producing sensory stimulation and resulting in a reflex bladder contraction.^6,26 It is also possible that patients with symptoms of mixed urinary incontinence do not really have two separate pathologic conditions of both urodynamic stress urinary incontinence and detrusor overactivity. Rather, mixed symptoms may be due to a more severe form of stress predominant incontinence. Bump et al²⁷ showed that in women who presented with predominant stress urinary incontinence symptoms, the major determinant of concurrent urge symptoms was incontinence severity. This may be another explanation of why mixed symptoms may resolve after successful anti-incontinence procedures.

There is currently no uniform diagnosis of urge incontinence. Our study is unique because it takes into account the difficulties in defining urge incontinence. Traditionally, the symptom of urge incontinence was defined by the involuntary loss of urine associated with a strong desire to void (urgency), and urgency was divided into motor urgency (overactive detrusor function) and sensory urgency (hypersensitivity).²⁸ Newer terms such as overactive bladder syndrome, urge syndrome, or urgency-frequency syndrome, which are associated with urgency, frequency and nocturia, but not necessarily urge incontinence, have recently been accepted by the International Continence Society.²⁴

We defined urge incontinence and overactive bladder symptoms based on patients’ perception of their symptoms on a standardized history, on the perceived need for an intervention in the form of anticholinergic therapy, and finally on their communication of these symptoms through a validated quality-of-life questionnaire. First we compared patients’ preoperative and postoperative urinary symptoms and found that the proportion of de novo urge incontinence was 9.1% and that the proportion of de novo overactive bladder symptoms was 4.3%. The resolution of preoperative urge incontinence symptoms was 63.1% and the resolution of preoperative overactive bladder symptoms was 57.3% after a TVT. We then compared preoperative and postoperative overactive bladder symptoms based on use of anticholinergics. We found the proportion of patients with de novo overactive bladder symptoms requiring an anticholinergic postoperatively was 8.7%, and the resolution of overactive bladder symptoms based on patients no longer requiring an anticholinergic postoperatively was 57.7%. Finally, we compared validated preoperative and postoperative quality-of-life questionnaires and found statistically significant improvement of all scores after a TVT. In fact, for the irritative subscale, 92.3% of patients with preoperative symptoms of stress incontinence had improvement, 3.8% had no change, and another 3.8% had worsening of their score after a TVT. The improvement, no change, and worsened rates of the irritative subscale for patients with preoperative symptoms of mixed incontinence were 87.8%, 2.0%, and 10.2%, respectively.

Evaluating the overall effect of the TVT on urgency, frequency and urge incontinence using 3 different criteria is a major strength of this study. By using these different methods we found similar outcomes, further corroborating the effect of the TVT on urge incontinence and overactive bladder symptoms. We included patients who had pure preoperative stress symptoms to estimate the proportion of postoperative de novo urge incontinence and overactive bladder symptoms, and we included patients who had preoperative symptoms of mixed incontinence to assess whether the urge component improved after a TVT.

The limitation of this study is the lack of objectivity in defining preoperative and postoperative urge incontinence. Rezapour and Ulmsten²⁹ previously reported on 80 patients with mixed incontinence confirmed by urodynamics and found that 85% were cured of both their stress and urge incontinence and another 4% were improved, without inducing de novo detrusor overactivity. All of the patients that were included in their study had preoperative and postoperative urodynamics studies, a cough stress test, a frequency/bladder chart, and 24-hour pad tests. Our study was retrospective in nature and lacked some of these objective criteria. However, our use of the validated questionnaires and preoperative and postoperative comparisons of overactive bladder symptoms and use of anticholinergics has its own strengths. Another limitation of the study that is also due to its retrospective nature is the difficulty in assessing if there were women who had overactive bladder symptoms preoperatively or postoperatively who were not treated with anticholinergics. Although this is a possibility, patients who reported overactive bladder symptoms were routinely offered an anticholinergic if they had a normal postvoid residual and no evidence of a urinary tract infection.

Previous bladder neck surgery was the only risk factor identified for the development of postoperative overactive bladder symptoms requiring an anticholinergic. There are several theories to explain why prior anti-incontinence surgery may result in overactive bladder symptoms after a TVT. It can cause bladder mucosa irritation or a foreign body reaction as well as alter autonomic innervation patterns to the pelvic floor muscles and bladder. Additionally, excessive urethral compression can lead to partial outflow obstruction, resulting in detrusor overactivity. Postoperative detrusor overactivity may also result from an increase in outflow resistance after a sling, which can unmask preexisting detrusor overactivity that occurs with increased bladder volumes.¹⁶

Although it was not our goal to determine the efficacy of the TVT in treating stress urinary incontinence, we have shown that with a mean follow-up period of 7 months, the failure rate was only 4.1%. After a TVT, the proportion with de novo symptoms of urge incontinence and overactive bladder symptoms was estimated to be low (9.1% and 4.3%, respectively). Approximately 63% of patients who have urinary urge incontinence symptoms preoperatively, and 57% of patients who have overactive bladder symptoms preoperatively, can expect resolution of these symptoms.

	Footnotes

 
The authors thank Aprylle Corbin, ma, and Peggy Walsh, rn, who helped collect and analyze the data.

Received June 3, 2004. Received in revised form September 8, 2004. Accepted September 16, 2004.

doi:10.1097/01.AOG.0000147596.44421.72

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Segal, J. L. Articles by Karram, M. M. Search for Related Content PubMed PubMed Citation Articles by Segal, J. L. Articles by Karram, M. M. Related Collections Gynecologic surgery Urogynecology