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Obstetrics & Gynecology 2001;98:638-645
© 2001 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Effect of Tension-Free Vaginal Tape Procedure on Urodynamic Continence Indices

Nina Mutone, MD, Marisa Mastropietro, MD, Edward Brizendine, MS and Douglass Hale, MD

From the Division of Female Pelvic Medicine and Reconstructive Surgery, Methodist Hospital, Indiana University School of Medicine, Indianapolis, Indiana and Division of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.

Address reprint requests to: Nina Mutone, MD, Division of Female Pelvic Medicine and Reconstructive Surgery, Indiana University School of Medicine, Methodist Hospital, 1633 North Capitol Avenue, Suite 436, Indianapolis, IN 46220; E-mail: nmutone{at}yahoo.com.


    ABSTRACT
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
OBJECTIVE: To assess the difference in measured urethral function before and after tension-free vaginal tape procedure (TVT).

METHODS: Women who underwent TVT for genuine stress incontinence with or without intrinsic sphincter deficiency completed this study. Multichannel urodynamic testing was performed preoperatively and 6 weeks postoperatively. Maximum urethral closure pressure and pressure transmission ratio were recorded. Valsalva leak point pressures were determined at 150 mL and at full bladder capacity. Resting and straining urethral angles were measured using the cotton swab technique. Subjects completed both the Incontinence Impact Questionnaire and Urodynamic Distress Inventory preoperatively and postoperatively.

RESULTS: Thirty-five consecutive women were studied. Twenty-three (65.7%) had a preoperative diagnosis of intrinsic sphincter deficiency as defined by maximum urethral closure pressure less than 20 cm H2O and/or Valsalva leak point pressure less than 60 cm H2O. Subjective and objective success rates were 91% and 83%, respectively. Subjects showed an 86.8% (95% CI 71.9%, 100.0%) improvement in their Incontinence Impact Questionnaire score and a 72.9% (95% CI 62.6%, 83.1%) improvement in their Urodynamic Distress Inventory score. The mean change in maximum urethral closure pressure was -1.3 cm H2O (95% CI -5.9, 3.3), whereas the pressure transmission ratio increased 15.7% (95% CI 5.0%, 26.3%). The mean decrease in straining urethral angle was 16.3° (95% CI -23.9°, -8.7°). Cured subjects demonstrating hypermobility preoperatively continued to do so postoperatively.

CONCLUSION: There was a significant increase in pressure transmission ratio, but not maximum urethral closure pressure, after TVT. These changes are similar to those reported after retropubic urethropexy and traditional sling procedures. The effectiveness of the TVT sling does not appear to depend on a clinically significant change in the straining urethral angle.

The tension-free vaginal tape (TVT) procedure for the treatment of genuine stress urinary incontinence in women was first reported in 1996.1 The surgical efficacy of TVT was later demonstrated in a report showing a cure rate of 86% at 3 years, comparable with other anti-incontinence operations.2 The TVT procedure is minimally invasive and can be performed under local anesthesia. In addition, TVT differs from other procedures in that it is positioned at the midurethra, rather than the urethrovesical junction, and is not anchored to any fixed anatomic structure.

The mechanism by which TVT induces urinary continence under stress is not understood. Urodynamic measures of urethral function, such as urethral pressure profile, leak point pressures, pressure transmission ratio, and degree of urethral mobility have been studied previously in attempts to characterize the effectiveness of retropubic urethropexies and pubovaginal slings. The present study’s objective is to characterize prospectively the effect of TVT on urethral function using pre- and postoperative urodynamic evaluation. In addition, short term (6-week) objective and subjective cure rates were recorded.


    MATERIALS AND METHODS
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Women undergoing a TVT procedure between January 1 and August 31, 2000, were eligible for inclusion in the study. Subjects were consecutively recruited from this patient population. The inclusion criterion for the study was a diagnosis of urodynamically proven genuine stress incontinence with or without intrinsic sphincter deficiency. Exclusion criteria were absence of preoperative urodynamic testing and patient inability to follow-up. All subjects were required to sign an informed consent approved by the Institutional Review Board at the Indiana University School of Medicine. Sample size calculations were based on the hypothesis that an absolute change of 20% in the pressure transmission ratio 6 weeks postoperatively would be clinically significant. Using a two-tailed t test at the 5% significance level and a standard deviation equal to twice the hypothesized difference, a sample of 33 subjects would have 80% power to detect this 20% difference as significant.

Subjects underwent TVT (Gynecare, Division of Ethicon, Inc., Somerville, NJ) suburethral sling according to the method previously described.1,3 All operations were performed by the faculty, or fellows under the direction of faculty, in the Division of Female Pelvic Medicine and Reconstructive Surgery at Indiana University/Methodist Hospital.

Patients had preoperative and 6-week postoperative history and physical examination, standing stress test, uroflowmetry, postvoid residual determination, urine culture, screening neurologic examination, multichannel urodynamic evaluation, and cotton swab test. All terminology conforms to the recommendations of the International Continence Society except where otherwise specified. Multichannel urodynamic evaluation (Dantek Technologies, Ottawa, Ontario, Canada) was performed using a 7-Fr microtip catheter and a 5-channel recorder. Testing included upright provocative water urethrocystometry at a filling rate of 80 mL/min, static urethral pressure profilometry at 50 mL and at maximum cystometric capacity, dynamic urethral pressure profilometry at maximum cystometric capacity, and Valsalva leak point pressure testing at bladder volumes of 150 mL and maximum cystometric capacity. The dynamic urethral pressure profile was performed by having the subject cough repetitively during the urethral pressure profile at maximum cystometric capacity. Pressure transmission ratio was determined by calculating the ratio of urethral pressure to vesical pressure within each of four quadrants of the dynamic urethral pressure profile and computing the mean. The cotton swab test was done by introducing a sterile cotton swab lubricated with xylocaine gel to the urethrovesical junction, leveling the table to the horizontal position, having the subject perform Valsalva, and recording the resting and maximal excursions with an orthopedic goniometer equipped with a level. Urethral hypermobility was defined as a straining urethral angle 30° or greater from the horizontal. Each subject also completed two standardized, validated quality of life assessment questionnaires,4 the Incontinence Impact Questionnaire and Urodynamic Distress Inventory.

The diagnosis of genuine stress incontinence was made if the subject had observable urine leakage with stress but without simultaneous detrusor activity during cystometry. Detrusor instability was diagnosed by the presence of detrusor contractions and urine leakage on cystometry. Intrinsic sphincter deficiency was defined as a maximum urethral closure pressure of less than 20 cm H2O at maximum cystometric capacity and/or Valsalva leak point pressure of less than 60 cm H2O at 150 mL bladder volume. A subject was preoperatively defined as having primary incontinence if she had not undergone a surgical procedure for stress incontinence in the past, and as having recurrent incontinence if she had. Subjective cure was defined as the absence of any symptoms of involuntary urine loss with stress or Valsalva at the time of the postoperative evaluation. Objective cure was defined as the absence of genuine stress incontinence on postoperative multichannel urodynamic testing. Postvoid residual was calculated by dividing the postvoid residual volume by the total bladder volume and multiplying by 100.

Outcomes are presented as a mean (standard deviation [SD]) or as a frequency (percent). The change and percent change at 6 weeks postoperation from preoperation were calculated on all urodynamic results. A 95% confidence interval (CI) was estimated for the mean change or percent change. McNemar’s test of symmetry was used to test for a change in categorical data. All analyses were performed using SAS V8.0.


    RESULTS
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Forty-nine patients underwent a TVT procedure between January 1 and August 31, 2000. Of these, 43 met inclusion criteria with 35 agreeing to participate. Subject characteristics are presented in Table 1Go.


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Table 1. Patient Characteristics (n = 49)
 
Subjects underwent TVT alone (25 of 35; 71.4%) or in conjunction with other operations (nine of 35; 28.7%). Concurrent operations performed for repair of prolapse included vaginal hysterectomy with anterior colporrhaphy and uterosacral ligament vaginal vault suspension (two), vaginal paravaginal cystocele repair with uterosacral ligament suspension (three), and rectocele repair (one). Other operations performed were sacral neuromodulation implant for severe urinary urgency and frequency (two) and laparoscopic cholecystectomy (one). The type of anesthesia used was intravenous sedation and local infiltration in 25 (71%), regional (epidural or spinal) in three (9%), and general in seven (20%). All patients who underwent TVT alone had intravenous sedation with local anesthesia. One (2.9%) of the procedures was complicated by bladder perforation, which was recognized at the time of surgery and healed spontaneously. There were no other complications among the total of 35 patients.

The subjective cure rate in the study group was 91.4% (32 of 35), the subjective cure/improved rate was 94.3% (33 of 35), and the objective urodynamic cure rate was 83% (29 of 35). All three subjects who subjectively failed were included in the total of six subjects who objectively failed. Of the three subjects who did not experience subjective cure, one reported marked improvement requiring no further therapy, and the other two reported no improvement. The subjective cure rate in the study group did not differ significantly from the subjective cure rate for all 14 nonstudy patients who underwent TVT during the defined time period (91% versus 90%; P = not significant). There was significant postoperative improvement in both the Urodynamic Distress Inventory and Incontinence Impact Questionnaire scores. Subjects improved their Urodynamic Distress Inventory score by an average of 72.9% (95% CI 62.6%, 83.1%). Incontinence Impact Questionnaire scores improved by 86.8% (95% CI 71.9%, 100.0%). Figures 1Go and 2Go present by-subject plots of the pre- and post-Incontinence Impact Questionnaire and Urodynamic Distress Inventory scores.



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Figure 1. Urodynamic Distress Inventory. Mean preoperative value: 65.0. Mean postoperative value: 15.7. P < .001.

Mutone. Urodynamics After TVT. Obstet Gynecol 2001.

 


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Figure 2. Incontinence Impact Questionnaire. Mean preoperative value: 69.5. Mean postoperative value: 4.3. P < .001.

Mutone. Urodynamics After TVT. Obstet Gynecol 2001.

 
Within the subset of subjects who had intrinsic sphincter deficiency, the subjective cure rate was 87.0% (20 of 23), and the objective cure rate was 78.3% (18 of 23). Within the subset of subjects who had recurrent incontinence, 91.7% (11 of 12) were subjectively and objectively cured. Within the subset of subjects who had both recurrent incontinence and intrinsic sphincter deficiency, 88.9% (eight of nine) were subjectively and objectively cured. The one remaining subject in both of the latter two groups was the same person; she was subjectively failed but improved. Of the total of six subjects in the study population who experienced objective urodynamic failure, five had a preoperative diagnosis of intrinsic sphincter deficiency. All three subjects who experienced subjective failure had a preoperative diagnosis of intrinsic sphincter deficiency, and two were also recurrent cases.

By-subject plots of the urodynamic results obtained before and after surgery are shown in Figures 3Go, 4Go, and 5Go. There was no significant change in mean maximum urethral closure pressure at maximum cystometric capacity preoperatively versus postoperatively (mean -1.3 cm H2O; 95% CI -5.9, 3.3). There was a significant decrease in the number of subjects with a positive Valsalva leak point at 150 mL less than 60 cm H2O (20 [57.1%] preoperatively versus five [14.3%] postoperatively; P < .001 [McNemar’s test]). The pressure transmission ratio increased by a mean of 15.7% (95% CI 5.0%, 26.3%). The mean straining urethral angle showed an overall decrease, from 67.9° (SD 20.7) preoperatively to 51.8° (SD 22.7) postoperatively, a mean change of -16.3° (95% CI -23.9°, -8.7°). However, all cured patients demonstrating urethral hypermobility preoperatively continued to do so postoperatively.



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Figure 3. Maximum urethral closure pressure. Mean preoperative value: 22.3. Mean postoperative value: 21.1. P = .579.

Mutone. Urodynamics After TVT. Obstet Gynecol 2001.

 


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Figure 4. Pressure transmission ratio. Mean preoperative value: 78.6. Mean postoperative value: 95.4. P = .005.

Mutone. Urodynamics After TVT. Obstet Gynecol 2001.

 


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Figure 5. Straining urethral angle. Mean preoperative value: 67.9. Mean postoperative value: 51.8. P < .001.

Mutone. Urodynamics After TVT. Obstet Gynecol 2001.

 
The mean postvoid residual (%) was 5.8 (SD 7.0) preoperatively and 17.3 (SD 25.4) postoperatively, for a mean change of 11.0% (95% CI 1.9%, 20.0%). There was one case of urinary retention, which was managed by intermittent self-catheterization. This eventually required lysis of the suburethral mesh under local anesthesia, with return of the patient’s voiding ability and incontinence symptoms. Thirty-two of the 35 subjects (91.4%) experienced a return to normal voiding within 48 hours of surgery. The remaining two patients voided normally within 1 week of surgery. There were no cases of de novo detrusor instability occurring postoperatively.


    DISCUSSION
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Most surgical procedures for the treatment of genuine stress incontinence fall into one of three groups: needle suspension of the bladder neck,5–8 retropubic urethropexy,9,10 and pubovaginal sling.11,12 The latter two types have been found to be significantly more efficacious than the first by the Female Stress Urinary Incontinence Clinical Guidelines Panel of the American Urological Association.13 The TVT is a type of sling performed in a specific manner, using a specially designed polypropylene mesh strip with a delivery system that places it beneath the midurethra under no tension. Because it is not anchored to any fixed anatomic structure, its mechanism of action may differ from operations that have this feature.

Several authors have reported the urodynamic effects of traditional incontinence operations. Both Hilton and Stanton14 and van Geelen et al15 found an increase in pressure transmission ratio but no change in static urethral pressure profilometry after Burch colposuspension. Rottenberg et al16 determined that enhancement of urethral pressure transmission, but not maximal urethral pressure, correlated with success from the Lyodura sling operation. Hilton17 studied the Stamey bladder neck suspension together with suburethral sling and found cure after both operations to be associated with enhanced pressure transmission ratio but not changes in resting urethral pressure profile. Most studies have shown significant increases in pressure transmission but not urethral closure pressure after incontinence surgery. In the only study to date reporting urodynamic changes after TVT, Wang18 found a decrease in the maximal urethral closure pressure at rest but no change in pressure transmission ratios.

The cotton swab test was first introduced in 1971 as a way to differentiate Type I and Type II stress urinary incontinence,19 though subsequent studies have not consistently borne out a relationship between urethral axis and the symptom or diagnosis of incontinence. The cotton swab test has also been used to assess stabilization of the urethra after operations that are designed to anchor the urethra or urethrovesical junction to fixed anatomic structures. Bergman and Elia20 reported that 91% of women after the Burch procedure had a negative cotton swab test after 5 years compared with 46% for the Pereyra and 30% for the Kelly procedures. The Burch procedure had a comparatively higher 5-year cure rate than the other two procedures, and the authors postulated that the negative cotton swab test result may have reflected a better surgical suspension of the bladder neck. Enzelsberger et al21 found a reduction in the resting and straining posterior urethral angles after sling surgery, this reduction being significantly more pronounced in subjects who achieved continence postoperatively than those who did not. Such studies have led to a general consensus that a successful anti-incontinence operation is characterized by postoperative elimination of urethral hypermobility. On the other hand, because of the tension-free nature of the TVT operation, the straining urethral angle may be unlikely to exhibit significant change postoperatively. In fact, Klutke et al22 assessed urethral mobility using the cotton swab test before and after TVT and found no significant change in straining angle despite an 85% cure rate.

This report is the first to directly compare the results of both multichannel urodynamic testing and cotton swab testing before and after TVT. Our findings are consistent with the majority of studies on retropubic urethropexies, needle procedures, and slings in that there is a significant increase in active pressure transmission to the urethra but no significant change in resting urethral closure pressure. However, the change in straining urethral axis after TVT is unlike the results seen in other studies with retropubic urethropexies. Though this report shows an overall decrease in the straining urethral angle, the small degree of this change, together with the fact that in each subject any preoperative hypermobility persisted postoperatively, indicates that this change is not likely to be clinically significant. These results must be interpreted in light of the known limitations of the q-tip test, including poor reproducibility and diagnostic ability. The mechanism of action of the TVT may be related to an improvement in urethral closure under stress without an anatomic change in urethral position. From information obtained by cadaver dissections, it has been proposed that the urethra is normally compressed during stress against a hammock-like supportive layer derived from the lateral attachments of the anterior vaginal wall to the arcus tendineus fascia pelvis.23 By way of the dense collagen reaction which forms around the mesh and within its interstices, the TVT may act by mimicking or reinforcing this hammock-type mechanism. Further investigation of this hypothesis, possibly by quantitative radiographic studies, is desirable.

Our results differ from those of Wang18 who found an increase in urethral closure pressure at rest but no significant increase in dynamic pressure transmission ratio after TVT. The urodynamic methods used in that report are not described, making it difficult to directly compare the difference in findings. However, our finding of an increase in pressure transmission is consistent with data from studies on other operations having high success rates in the treatment of stress incontinence. As continence under stress is a dynamic mechanism, dynamic measures are more likely to reflect the action of TVT than static pressure readings.

TVT is indicated for the treatment of primary genuine stress incontinence, though many unpublished reports have described its use in subjects with recurrent incontinence or intrinsic sphincter deficiency. The fact that a majority of subjects in our study group had intrinsic sphincter deficiency or recurrent incontinence reflects the referral nature of our population. The subset of patients with intrinsic sphincter deficiency had overall lower cure rates than the study population as a whole. Of the six patients with objective surgical failure, five had a preoperative diagnosis of intrinsic sphincter deficiency. The two subjects who had subjective failure and lack of improvement after the operation deserve special mention. Both of these subjects had a preoperative diagnosis of intrinsic sphincter deficiency. Both of these subjects also underwent concurrent repair of a Stage III cystocele using a cadaveric fascia lata graft. In both cases, the anterior vaginal wall was found postoperatively to be rigidly supported with no descent upon straining, despite the fact that both patients had demonstrated urethral hypermobility preoperatively. It is possible that the cystocele repair eliminated bladder mobility, which was needed for the TVT to adequately compress the urethra during stress. The possible confounding effect of this or other concurrent operations could not be statistically assessed in this study because of the small numbers. The small numbers also precluded analysis of how the presence of mixed incontinence could have affected outcome. However, these issues should be investigated in future research.

This study demonstrates that the high success rate of TVT in the treatment of genuine stress incontinence is associated with an increase in pressure transmission to the urethra but not with a change in urethral closure pressure nor a decrease in urethral hypermobility. Overall, the short-term success rate of TVT was well preserved even in patients with intrinsic sphincter deficiency or recurrent incontinence. Though these numbers are small, they suggest that TVT may be useful in the treatment of those subgroups of patients as well as those with primary, uncomplicated genuine stress incontinence. Further studies involving larger numbers of these patients will be necessary. Long-term studies will be important to assess the durability of surgical success as well as the incidence of late-developing complications. It may be of particular interest to characterize intrinsic sphincter deficiency patients more thoroughly with regard to which aspects of sphincter dysfunction, if any, may affect the likelihood of surgical cure with TVT.


    Footnotes
 
Supported by Gynecare, Division of Ethicon, Inc., Somerville, NJ. Gynecare manufactures the tension-free vaginal tape (TVT) device used in the study.

PII S0029-7844(01)01515-0

Received February 27, 2001. Received in revised form June 11, 2001. Accepted June 22, 2001.


    REFERENCES
 TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
1. Ulmsten U, Henriksson L, Johnson P, Varhow G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996;7:81–6.

2. Ulmsten U, Johnson P, Rezapour M. A three-year follow up of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obstet Gynecol 1999;106:345–50.[Medline]

3. Ulmsten U, Petros P. Intravaginal sling plasty (IVS): An ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Nephrol 1995;29:75–82.

4. Uebersax J, Wyman JF, Shumaker SA, McClish DK, Fantl JA, and the Continence Program for Women Research Group. 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;14:31–9.

5. Pereyra AJ. A simplified surgical procedure for the correction of stress incontinence in women. West J Surg 1959; 67:223–6.

6. Stamey TA. Endoscopic suspension of vesical neck for urinary incontinence. Surg Gynecol Obstet 1973;136: 547–8.[Medline]

7. Raz S. Modified bladder neck suspension for female stress incontinence. Urology 1981;17:82–4.[Medline]

8. Gittes RF, Loughlin KR. No-incision pubovaginal suspension for stress incontinence. J Urol 1987;138:568–70.[Medline]

9. Marshall VF, Marchetti AA, Krantz KE. The correction of stress incontinence by simple vesicourethral suspension. Surg Gynecol Obstet 1949;88:509–18.[Medline]

10. Burch JC. Cooper’s ligament urethrovesical suspension for stress incontinence. Am J Obstet Gynecol 1968;88: 509–18.

11. Aldridge AH. Transplantation of fascia for relief of urinary stress incontinence. Am J Obstet Gynecol 1942;44:398.

12. Jeffcoate TNA. The results for the Aldridge sling operation for stress urinary incontinence. J Obstet Gynaecol 1956; 63:36–9.

13. Leach GL, Dmochowski RR, Appell RA, Blaivas JG, Hadley HR, Luber KM, et al. Female stress urinary incontinence clinical guidelines panel summary report on surgical management of female stress urinary incontinence. J Urol 1997;158;875–80.[Medline]

14. Hilton P, Stanton SL. A clinical and urodynamic assessment of the Burch colposuspension for genuine stress incontinence. Br J Obstet Gynecol 1983;90:934–9.[Medline]

15. van Geelen JM, Theeuwes AG, Eskes TK, Martin CB Jr. The clinical and urodynamic effects of anterior vaginal repair and Burch colposuspension. Am J Obstet Gynecol 1988;159:137–44.[Medline]

16. Rottenberg RD, Weil A, Brioschi PA, Krauer F. Urodynamic and clinical assessment of the Lyodura sling operation for urinary stress incontinence. Br J Obstet Gynecol 1985;92:829–34.[Medline]

17. Hilton P. A clinical and urodynamic study comparing the Stamey bladder neck suspension and suburethral sling procedures in the treatment of genuine stress incontinence. Br J Obstet Gynecol 1989;96:213–20.[Medline]

18. Wang AC. An assessment of the early surgical outcome and urodynamic effects of the tension-free vaginal tape (TVT). Int Urogynecol J 2000;11:282–4.

19. Crystle CD, Charme LS, Copeland WE. Q-tip test in stress urinary incontinence. Obstet Gynecol 1971;38: 313–5.[Medline]

20. Bergman A, Elia G. Three surgical procedures for genuine stress incontinence: Five-year follow up of a prospective randomized study. Am J Obstet Gynecol 1995;173:66–71.[Medline]

21. Enzelsberger H, Schatten C, Kurz C, Fitzal P. Urodynamic and radiologic parameters before and after loop surgery for recurrent urinary stress incontinence. Acta Obstet Gynecol Scand 1990;69:51–4.[Medline]

22. Klutke JJ, Carlin BI, Klutke CG. The tension-free vaginal tape procedure: Correction of stress incontinence with minimal alteration in proximal urethral mobility. Urology 2000;55:512–4.[Medline]

23. DeLancey JOL. Structural support of the urethra as it relates to stress urinary incontinence: The hammock hypothesis. Am J Obstet Gynecol 1994;170:1713–23.[Medline]





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