Update of AUA Guideline on the Surgical Management of Female Stress Urinary Incontinence

Article Outline

• Abstract
• Methodology
• Diagnostic Evaluation of the Index Patient
  • Standard: The evaluation of the index patient should include
  • Recommendation: Elements of the history should include
  • Recommendation: Additional diagnostic studies that can be performed to assess the integrity and function of the lower urinary tract include
  • Recommendation: Indications for further testing include
• Outcomes Analysis: Retropubic Suspensions and Slings
  • Cured/Dry Rates
  • Urgency
  • Retention
  • Complications
• Outcomes Analysis: Transobturator Tape Procedures
• Outcomes Analysis: Injectable Agents
• Outcomes Analysis: Artificial Urinary Sphincters
• Treatment Guideline Statements for the Index Patient
• Recommendations for Future Research and Reporting
• Acknowledgments and Disclaimers
• References
• Copyright

Purpose

We updated the 1997 American Urological Association guideline on female stress incontinence.

Materials and Methods

MEDLINE® searches of English language publications from 1994 and new searches of the literature published between December 2002 and June 2005 were performed using identified MeSH terms. Articles were selected for the index patient defined as the otherwise healthy woman who elected to undergo surgery to correct stress urinary incontinence or the otherwise healthy woman with incontinence and prolapse who elected to undergo treatment for both conditions.

Results

A total of 436 articles were identified as suitable for inclusion in the meta-analysis, and an additional 155 articles were suitable for complications data only due to insufficient followup of efficacy outcomes in the latter reports. Surgical efficacy was defined using outcomes pre-specified in the primary evidence articles. Urgency (resolution and de novo) was included as an efficacy outcome due to its significant impact on quality of life. The primary efficacy outcome was resolution of stress incontinence measured as completely dry (cured/dry) or improved (cured/improved). Complications were analyzed similarly to the efficacy outcomes. Subjective complications (pain, sexual dysfunction and voiding dysfunction) were also included as a separate category.

Conclusions

The surgical management of stress urinary incontinence with or without combined prolapse treatment continues to evolve. New technologies have emerged which have impacted surgical treatment algorithms. Cystoscopy has been added as a standard component of the procedure during surgical implantation of slings.

Key Words: urinary retention, urinary incontinence, stress, urinary incontinence, urge, urologic surgical procedures

Abbreviation and Acronyms: AUA, American Urological Association, AUS, artificial urinary sphincter, FDA, Food and Drug Administration, SUI, stress urinary incontinence, UTI, urinary tract infection

Stress urinary incontinence has a major impact on the quality of life for many women, although estimates of prevalence vary widely.¹ A large meta-analysis reported a prevalence estimate of 30% for urinary incontinence in women 30 to 60 years old, with approximately half attributed to SUI,² while another study reported the prevalence of SUI to range from 5% to 30%.³ In 1997 the American Urological Association published a guideline on female stress incontinence which focused on the patient with SUI without significant pelvic organ prolapse.⁴ It has since become apparent that many women with SUI also have pelvic organ prolapse, and that surgical procedures for SUI and prolapse may be performed concurrently. For this reason, the AUA elected to produce this guideline update.

The index patient is defined as 1) an otherwise healthy woman who has elected surgical therapy for the correction of SUI or 2) an otherwise healthy woman with SUI and prolapse who elects to undergo treatment for both conditions. Stress urinary incontinence is a symptom of leakage of urine during events that result in increased abdominal pressure such as sneezing, coughing, physical exercise, lifting, bending or even changing positions. The 2 underlying entities that contribute to this symptom are SUI and the rarer stress-induced detrusor overactivity (involuntary detrusor contractions caused by sudden increases in abdominal pressure). Urgency refers to a sudden, compelling desire to pass urine which is difficult to defer⁵ or a strong need to pass urine for fear of leakage.⁶ Urge urinary incontinence is defined as involuntary leakage accompanied by or immediately preceded by urgency,⁵ and mixed incontinence refers to SUI that occurs in combination with urge urinary incontinence.

Back to Article Outline

Methodology 

MEDLINE® searches of English language publications from 1990 or later (from the previous guideline) and searches of the literature published from December 2002 through June 2005 were performed using the MeSH terms “female” and “urinary incontinence, stress,” “stress incontinence” or “urinary incontinence.” A total of 436 articles were identified as suitable for inclusion in the meta-analysis. An additional 155 articles were suitable for complications data only due to insufficient follow-up of efficacy outcomes in these reports (for a detailed methodology and meta-analytic findings see the complete Guideline at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm). Data were extracted from the articles and meta-analyzed according to the several definitions.

Surgical efficacy was defined using outcomes prespecified in the primary evidence articles, which included 1) resolution and lack of recurrence of SUI and urgency; 2) resolution of prolapse and lack of recurrence or new onset of prolapse; and 3) incidence and severity of adverse events of these treatments. Urgency (resolution and de novo) was included as an efficacy outcome due to its significant impact on quality of life. For the analysis of postoperative urgency, cases were divided into the 3 categories of without preexisting urgency, with preexisting urgency and unknown or uncertain pre-existing urgency. Postoperative urgency categories included urge incontinence, urge symptoms and unspecified. The primary efficacy outcome was resolution of stress incontinence measured as completely dry (cured/dry) or improved (cured/dry/improved). The data are reported as percentages and credible intervals (Bayesian confident intervals).

Outcomes were analyzed separately based on whether the continence evaluation was subjective or objective, and only results that were clearly based on subjective or objective criteria were included in their respective analyses. An additional category was created, defined as “any” method of evaluation, to include all studies irrespective of the method of assessment. For studies reporting subjective and objective results, the subjective results of the study were included in the “any” category. Outcomes also were analyzed separately according to the postoperative interval of the final assessment of continence, with a minimum period of followup of 12 months. The 3 intervals analyzed were 12 to 23 months, 24 to 47 months and greater than 48 months. If a study reported data at multiple times during one of these intervals, the time point closest to 18 months, 36 months and 60 months was used for the 3 time ranges.

Complications were analyzed similarly to the efficacy outcomes (see the complete guideline for additional information and outcomes data. To facilitate the analysis of complications for the various SUI surgical procedures and because of the lack of standardized nomenclature in the literature, the Panel grouped the reported complications into urinary retention, perioperative genitourinary, delayed genitourinary, gastrointestinal, vascular, neurological, infectious, general medical and death. Subjective complications (pain, sexual dysfunction and voiding dysfunction) were also included as a separate category.

The treatments included in the analysis were retropubic suspensions, slings, injectable therapy and artificial sphincters, and procedures not generally available in the United States were excluded from analysis. Anterior repairs for prolapse reduction in conjunction with other surgical treatments for incontinence were included as prolapse surgeries. Procedures used to correct prolapse included hysterectomy in conjunction with or as a component of surgical treatment of SUI and site specific repairs.

Based on the outcomes of the analysis, guideline statements were developed by the Panel. These statements were graded with respect to the degree of flexibility in application. As a treatment policy, a “standard” has the least flexibility, a “recommendation” has significantly more flexibility, and an “option” is even more flexible. A guideline statement is a standard if 1) the health outcomes of the alternative interventions are sufficiently well-known to permit meaningful decisions and 2) there is virtual unanimity about which intervention is preferred. A guideline statement is a recommendation if 1) the health outcomes of the alternative interventions are sufficiently well-known to permit meaningful decisions and 2) an appreciable but not unanimous majority agrees on which intervention is preferred. A guideline statement is an option if 1) the health outcomes of the interventions are not sufficiently well-known to permit meaningful decisions or 2) preferences are unknown or equivocal.

Back to Article Outline

Diagnostic Evaluation of the Index Patient 

Although the meta-analysis did not encompass diagnostic evaluation of the index patient, the Panel developed guideline statements based on consensus. They defined the purpose of diagnostic evaluation as 1) to provide documentation and characterization of SUI, 2) to assess the differential diagnosis and comorbidities, and 3) to aid in the choice of treatment and in determining the prognosis. The definitive diagnosis of SUI is based on involuntary urine loss from the urethral meatus coincident with increased abdominal pressure (positive stress test) such as that occurring during coughing and straining in a patient who complains of stress incontinence.

Standard: The evaluation of the index patient should include 

(Based on Panel consensus)

Recommendation: Elements of the history should include 

(Based on Panel consensus)

Recommendation: Additional diagnostic studies that can be performed to assess the integrity and function of the lower urinary tract include 

(Based on Panel consensus)

Recommendation: Indications for further testing include 

(Based on Panel consensus)

Back to Article Outline

Outcomes Analysis: Retropubic Suspensions and Slings 

See the complete guideline for a description of all of the results http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm.

Cured/Dry Rates 

For an estimation of resolution rates, cured/dry and cured/dry/improved outcomes were analyzed but only cured/dry outcomes are presented (for cured/dry/improved rates, see the complete guideline). Data from retropubic open suspensions regardless of type (including Burch suspensions), open Burch suspensions alone and laparoscopic suspensions were analyzed. The estimated cured/dry rates at 12 to 23 months were 82% (95% CI 74 to 87) for open suspensions without concomitant prolapse treatment and 69% for laparoscopic suspensions (95% CI 52 to 84) (table 1). Due to the overlap in these CIs, the results are not considered significantly different. At 24 months and beyond the cured/dry rates were similar among all procedures, ranging from 73% to 76%. Data were comparable for studies in which any patient received concomitant prolapse treatment (table 2).

Table 1. Cured/dry analysis of no concurrent prolapse treatment by any evaluation method including subjective and objective

	12–23 Mos		24–47 Mos		48 Mos or Greater
	No. Groups/No. Pts.	% Median (95% CI 2.5–97.5)	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)
Suspensions:
All open retropubic	15/1,085	82 (74–87)	13/803	76 (68–82)	17/1,259	73 (64–77)
Burch	14/1,070	81 (73–87)	12/775	76 (68–83)	13/1,065	73 (65–80)
Laparoscopic	9/368	69 (52–84)	4/172	74 (61–85)
Slings:
Autologous fascial
Without bone anchors	4/342	90 (76–98)	6/232	81 (72–88)	4/368	82 (67–93)
Vaginal wall slings with/without bone anchors	1/39	79 (65–90)			1/29	96 (85–100)
Vaginal wall slings with bone anchors			1/58	79 (68–88)
Cadaveric without bone anchors	1/104	74 (65–82)	2/71	80 (43–98)
Synthetic at bladder neck
With bone anchors	2/34	88 (71–97)			1/27	92 (78–98)
Without bone anchors			9/349	73 (64–80)
Synthetic at midurethra	14/1,215	84 (78–89)	7/483	81 (72–88)	3/199	84 (77–89)
Injectable agents: collagen	7/340	48 (41–55)	4/210	32 (24–42)	1/40	30 (18–45)

Table 2. Cured/dry analysis of any patient in the group/arm receiving concurrent prolapse treatment by any evaluation including subjective and objective

	12–23 Mos		24–47 Mos		48 Mos or Greater
	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)	No. Groups/No. Pts	% Median (95% CI 2.5%–97.5%)
Suspensions:
All open retropubic	9/517	88 (83–92)	9/403	83 (75–90)	13/1,072	67 (56–76)
Burch	9/517	88 (83–92)	7/333	85 (75–93)	12/954	65 (53–74)
Laparoscopic	12/564	88 (85–91)	7/359	83 (73–91)	1/34	88 (74–96)
Slings:
Autologous fascial
Without bone anchors	3/78	92 (82–97)	1/80	85 (76–92)
Vaginal wall slings with/without bone anchors	1/20	70 (48–86)	2/60	89 (64–99)	1/82	95 (89–98)
Vaginal wall slings with bone anchors, suprapubic	1/19	99 (88–100)	1/9	87 (59–99)
Cadaveric
With bone anchors, transvaginal	1/234	82 (77–86)
Without bone anchors	3/133	58 (36–78)	2/92	64 (21–95)	1/13	31 (11–58)
Homologous dermis without bone anchors			1/19	89 (70–98)
Synthetic at bladder neck
With bone anchors, suprapubic					1/49	85 (74–93)
With bone anchors, transvaginal			1/32	81 (65–92)
Without bone anchors	1/20	94 (79–99)	3/184	75 (56–90)	3/182	73 (62–82)
Synthetic at midurethra	14/1,089	85 (80–89)	11/881	87 (81–91)	2/101	76 (64–85)
Other sling	1/126	92 (86–96)

Efficacy data were available for a variety of types of autologous fascial slings, including autologous slings without bone anchors and autologous vaginal wall slings with or without bone anchors. Most of the studies described patients treated with autologous slings without bone anchors. The estimated cured/dry rates with no prolapse treatment ranged between 90% at 12 to 23 months and 82% at 48 months or longer (table 1). Again, efficacy was similar for studies in which any patient received concurrent prolapse treatment (table 2).

Cadaveric slings came into wide use following a report by Handa et al.⁷ However, the long-term durability of these procedures has been questioned⁸, ⁹, ¹⁰, ¹¹, ¹², ¹³, ¹⁴, ¹⁵ and, due to the decline in the use of cadaveric slings, limited data were available for analysis. The estimated cured/dry rates for patients undergoing cadaveric sling procedures without bone anchors and no concomitant prolapse treatment were 74% at 12 to 23 months and 80% at 24 to 47 months (table 1). There were no longer term (48 months or greater) efficacy data available. For the studies in which any patient received concomitant prolapse treatment, the estimated cured/dry rates at 12 to 23 months were 82% (95% CI 77 to 86%) with bone anchors and 58% (95% CI 36 to 78) without bone anchors (table 2). Despite the fact that these confidence intervals had little overlap suggesting the difference may be significant, the Panel considered this a statistical aberration due to the small number of patients rather than a true difference.

For synthetic slings, efficacy data were available for slings placed at the bladder neck and slings placed at the midurethra. For slings at the bladder neck, most of the data were on slings without bone anchors and the estimated cured/dry rate without prolapse treatment was 73% at 24 to 47 months (table 1). Longer term data were not available. For slings at the bladder neck with concurrent prolapse treatment, the estimated cured/dry rates were similar (table 2). For slings at the midurethra without prolapse treatment (transvaginal/retropubic technique), the estimated cured/dry rates ranged from 81% to 84% (table 1). Results were comparable for studies in which any patient received concurrent prolapse treatment (table 2).

Urgency 

The estimates of urge incontinence outcomes (whether de novo or those with preexisting urgency) at 12 to 23 months are shown in table 3. The “unspecified” category included studies in which the preoperative urgency status of patients with postoperative urgency was not reported, and those in which patients with and without preoperative urgency were combined. There were few data for long-term outcomes. For all open retropubic and Burch suspensions, the estimate of de novo urge incontinence was 8%, and the postoperative urge incontinence estimates for those with preexisting urge incontinence were 14% and 17%, respectively. The unspecified urge incontinence estimate was 41% for both procedures (table 3). Of the small number of patients undergoing laparoscopic retropubic suspensions the estimate was 5% for de novo urge incontinence and 6% for unspecified urge incontinence. There were no data for patients with preexisting urge incontinence. The postoperative urge incontinence estimate for patients with preexisting urge incontinence treated with open retropubic suspensions with concurrent prolapse repair was approximately 22%. The estimates for de novo urge incontinence and unspecified urge incontinence were 14% and 13%, respectively (table 3).

Table 3. Urge incontinence outcomes at 12 to 23 months

	De Novo		Preexisting		Unspecified
	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)
Studies in which no pt received concurrent prolapse treatment
Suspensions:
All open retropubic	10/713	8 (5–12)	5/186	14 (6–25)	4/305	41 (30–54)
Burch	9/695	8 (5–11)	3/108	17 (4–40)	4/305	41 (30–54)
Laparoscopic	2/112	5 (1–14)			2/100	6 (1–14)
Slings:
Autologous fascial
Without bone anchors	4/329	9 (6–13)	4/358	33 (28–40)
Vaginal wall slings with/without bone anchors			1/13	9 (1–31)
Vaginal wall slings with bone anchors
Cadaveric without bone anchors	1/25	28 (13–47)	1/38	21 (10–36)
Synthetic at bladder neck with bone anchors			1/6	96 (67–100)
Synthetic at bladder neck without bone anchors	4/132	12 (6–20)	1/24	17 (6–35)
Synthetic at midurethra	7/323	6 (3–10)	1/25	44 (26–63)	2/532	22 (3–58)
Other sling
Injectable agents: collagen	1/337	13 (10–17)			1/50	8 (3–18)
Studies in which any pt received concurrent prolapse treatment
Suspensions:
All open retropubic	10/457	14 (8–21)	2/143	22 (4–56)	2/256	13 (7–22)
Burch	9/417	14 (8–22)	1/25	48 (30–67)	2/256	13 (7–22)
Laparoscopic	5/344	11 (6–17)			1/32	4 (0–14)
Slings:
Autologous fascial
Without bone anchors	2/97	10 (4–19)
Vaginal wall slings with/without bone anchors	3/65	13 (2–36)	2/15	47 (21–75)
Vaginal wall slings with bone anchors suprapubic	1/9	13 (1–41)
Cadaveric with bone anchors, transvaginal	1/238	6 (3–9)
Homologous tissue (dermis) without bone anchors	1/5	22 (2–63)
Synthetic at bladder neck without bone anchors	4/150	15 (5–31)	3/119	29 (16–46)
Synthetic at midurethra	11/805	11 (7–16)	5/107	52 (38–66)	2/174	9% (1–38)

For autologous fascial slings without bone anchors, the estimated rate of de novo urge incontinence was 9% and the rate of postoperative urge incontinence in patients with preexisting urge incontinence urge was 33% (table 3). For synthetic slings at the midurethra, the estimate was 6% for de novo urge incontinence and 22% for unspecified urgency. For studies in which any patient had concurrent prolapse treatment, the de novo urgency rate was 11%.

Retention 

Retention, defined as that lasting longer than 1 month or requiring intervention, estimates were generally low (table 4). However, the estimated rate of retention for autologous fascial slings without bone anchors was 8% for patients not receiving concurrent prolapse treatment and 5% for patients receiving concurrent prolapse treatment. The retention rate for synthetic slings at the bladder neck was estimated at 9% for those without concurrent prolapse repair and 10% for those receiving concurrent prolapse treatment, while the retention rate for synthetic slings at the midurethra was 3% for both groups. The difference in retention rates between synthetic slings placed at the midurethra and those placed at the bladder neck was considered by the Panel to be an important finding.

Table 4. Retention for more than 1 month or requiring intervention

	No Prolapse Treatment		Prolapse Treatment
	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)	No. Groups/No. Pts	% Median (95% CI 2.5–97.5)
Suspensions:
All open retropubic	8/619	4 (1–8)	13/851	1 (1–3)
Burch	5/347	3 (1–7)	10/710	1 (1–3)
Laparoscopic	5/188	4 (1–8)	11/482	2 (1–4)
Slings:
Autologous fascial
Without bone anchors	8/480	8 (4–15)	3/301	5 (2–11)
Vaginal wall slings with/without bone anchors	2/68	2 (0–8)	3/142	5 (1–17)
Suprapubic			1/25	1 (0–9)
Cadaveric without bone anchors			1/26	1 (0–10)
Synthetic at bladder neck
With bone anchors, suprapubic			1/49	4 (1–12)
With bone anchors, transvaginal			2/99	1 (0–6)
Without bone anchors	4/360	9 (5–15)	7/422	10 (5–18)
Synthetic at midurethra	17/2,119	3 (2–4)	11/1,107	3 (2–5)
Injectable agents: collagen	2/104	1 (0–5)

Complications 

For a description and summary of the complications data, see the complete guideline document (http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm).

Common complications and estimated rates of occurrence for open retropubic suspensions were fever (8%), urinary tract infection (13%), bladder injury (4%) and voiding dysfunction (9%). Common complications for Burch suspension were fever (11%), UTI (15%), bladder injury (6%) and voiding dysfunction (10%). Laparoscopic suspensions appeared to have a lower overall risk of febrile complications (0%) and UTI (2%), although these estimates were based on limited data. Ureteral injury rates were 11% of laparoscopic retropubic suspensions compared to only 1% of open suspensions. Again, these estimates were based on a small number of patients. Complication estimates for autologous fascial slings without bone anchors were generally infrequent and included UTI (11%), bladder injury (4%) and wound complications (8%). For cadaveric slings, vaginal extrusion was reported in 1 study¹⁶ but erosion of cadaveric materials into the urinary tract was not identified in this meta-analysis. When these materials were used with concomitant prolapse repair, complications such as infection and graft extrusion were reported.¹⁷

Complications occurring with synthetic slings at the bladder neck without bone anchors included UTI (10%) and erosion/extrusion (5% urethral/bladder, 8% vaginal and 17% unknown). While these data may overestimate the risk of complications, they do suggest increased rates of urinary tract erosion following synthetic slings placed at the bladder neck. Complication rates for synthetic slings placed at the midurethra included bladder injury (6%), UTI (11%) and extrusions (7% vaginal and 1% unknown). Overall reported complication rates were generally higher than recently reported data. Wound complications were also reported in the literature. Recently, the United States FDA released a warning position statement concerning the use of mesh materials in stress incontinence surgery and pelvic organ prolapse surgery, noting more than 1,000 reported complications of vaginal and urinary erosion as well as bowel and vascular injuries (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm).

Back to Article Outline

Outcomes Analysis: Transobturator Tape Procedures 

Modifications to the pubovaginal sling for the surgical treatment of SUI include the tension-free vaginal tape procedure introduced in 1996 ¹⁸ and the transobturator technique introduced in 2001.¹⁹, ²⁰, ²¹ Since the cutoff date for the literature review for this guideline was June 2005, limited data were available in the peer-reviewed literature to analyze these procedures, although subsequently numerous studies have been published. The Panel is aware of the importance of the transobturator technique in the treatment of SUI.

Back to Article Outline

Outcomes Analysis: Injectable Agents 

Injectable agents are an option for patients who do not wish to undergo more invasive surgery, and who understand that efficacy and duration are inferior to surgery. Other possible indications include elderly patients, those at high anesthetic risk and those willing to accept improvement in the incontinence without necessarily achieving dryness.

For this analysis, injectable agents were subdivided into collagen (bovine gluteraldehyde cross-linked) and other nondegradable synthetic agents. Sufficient data were available only for an analysis of collagen. The cured/dry estimates for patients treated with collagen without concomitant prolapse decreased from 48% at 12 to 23 months to 32% at 24 to 47 months (table 1). The postoperative rates of urge incontinence as well as the rates of complications were low. Limited information was available for the other injectable agents, except for data from the multicenter trials that led to FDA approval for carbon-coated zirconium beads in beta-glucan gel²² and calcium hydroxylapatite.²³ Overall, there were limited data with which to assess the long-term safety and efficacy of injectable agents.

Back to Article Outline

Outcomes Analysis: Artificial Urinary Sphincters 

Data on the use of the artificial urinary sphincter in the index patient were limited, precluding analysis. The AUS is occasionally used in the patient with severe intrinsic sphincteric deficiency after other surgical procedures have failed or in those with diabetes or back injury and significant SUI and poor bladder contractility. Erosion, infection and device malfunction are potential complications. Based on the only recent study of complications the erosion/extrusion rate was 28%.²⁴ With respect to the index patient the AUS might be useful in the woman using the Valsalva maneuver to void who must abdominally strain to empty the bladder. When the cuff is opened for voiding, the AUS is not likely to be obstructive to the bladder in contrast to slings when straining may cause obstruction to the urinary flow. The Panel believes the role of the AUS in the treatment of SUI is limited.

Back to Article Outline

Treatment Guideline Statements for the Index Patient 

The index patient has genuine stress urinary incontinence with or without prolapse. The use of a prophylactic anti-incontinence procedure in the patient with occult incontinence with high grade prolapse is not the guideline index patient, and the Panel does not have an opinion about prophylactic incontinence surgery.

Although there is no peer-reviewed literature that specifically evaluates these uncommon conditions, the Panel believes that using synthetic material may place the patient at higher risk for subsequent urethral erosion, vaginal extrusion, urethrovaginal fistula and foreign body granuloma formation. In such patients the Panel believes that autologous fascial and alternative biological slings are options in the treatment of concomitant stress incontinence. The decision to use these materials should be based on the judgment of the surgeon and made in the best interests of the patient.

For optimum detection of potential intraoperative complications, the urethra should be inspected with either a short beak rigid cystoscope or a flexible cystoscope.

Newer techniques and materials for the surgical treatment of stress incontinence have or are being developed. For the index patient, the Panel believes that these techniques, materials, and accompanying physician expertise and experience offer a number of advantages that include shorter operative time, shorter recovery time and less short-term morbidity. However, urethral erosion and vaginal extrusion of the synthetic material may occur, which can be difficult to treat. In addition, perforation of bowel and blood vessels, which pose a life threatening risk, may result from this procedure. Longer followup is needed before any definitive statements regarding the long-term efficacy and life long risk of erosion with these procedures can be made.

The Panel considers the use of the AUS in the index patient as an option, with a limited role for those not amenable to treatment with other procedures.

Ample support exists for the role of surgery in mixed incontinence.²⁵ The meta-analysis estimate of postoperative urge incontinence was 14% from data on 186 patients (95% CI 6 to 25) with pre-existing urge incontinence when treated with open retropubic suspensions while others have reported disparate outcomes.²⁶

Back to Article Outline

Recommendations for Future Research and Reporting 

Although more than a decade has passed since the recommendations for improving the quality of data from clinical trials and studies were proposed in the 1997 AUA Panel report,⁴ little progress has been made by editors and reviewers in instituting these recommendations.²⁷ Furthermore, the FDA has not altered the approval process. Thus, again, the Panel members were disappointed in data available for meta-analysis. In addition to the specific recommended outcome measures in the original Panel report,⁴ editors and their reviewers should require the following:

For adverse event data, complications should be categorized as those occurring intraoperatively or postoperatively. It is essential to report the following adverse event data:

The profession at large and the individual physician should ensure the safety and efficacy of any new device or sling. If safety and efficacy have not been shown with reasonable certainty, the new treatment should only be performed as part of clinical research studies and/or with informed consent recognizing that safety and/or efficacy has not been demonstrated.

Back to Article Outline

Acknowledgments and Disclaimers 

This document was written by the Female Stress Urinary Incontinence Update Panel of the American Urological Association Education and Research, Inc., which was created in 2002. The Practice Guidelines Committee of the AUA selected the committee chair and panel members were selected by the chair. Membership of the committee included urologists and gynecologists with specific expertise on this disorder. The mission of the committee was to develop recommendations that are analysis based or consensus based, depending on Panel processes and available data, for optimal clinical practices in the diagnosis and surgical treatment of female SUI. This document was submitted for peer review to 76 urologists and other health care professionals. After the final revisions were made based upon the peer review process, the document was submitted to and approved by the Practice Guidelines Committee and the AUA Board of Directors. Funding of the committee was provided by the AUA. Committee members received no remuneration for their work. Each member of the committee provided a conflict of interest disclosure to the AUA.

This report is intended to provide medical practitioners with a consensus of principles and strategies for the surgical treatment of female stress urinary incontinence. The report is based on current professional literature, clinical experience and expert opinion. It does not establish a fixed set of rules or define the legal standard of care, and it does not preempt physician judgment in individual cases.

Statistical analysis was provided by Hanan S. Bell, PhD, data compilation by Patrick M. Florer and editorial support by Linda Whetter, DVM, PhD of Zola Associates.

All Panel members completed conflict of interest disclosures. (C) indicates compensation was received and (U) indicates no compensation was received. Consultant or Advisor: Rodney Appell, Boston Scientific (C), Allergan (C), Astellas (C), Bayer, Schering-Plough (C), Pfizer (C), American Medical Systems (C); Roger R. Dmochowski, Novartis (C), Pfizer (C), Astellas (C), Watson Pharmaceuticals (C), Lilly (C); Mickey M. Karram, Astellas (C), Cooper Surgical (C), EWH&U (C); Karl M. Luber, Watson Pharmaceuticals (C), Indevus (C), Pfizer (C), Astella (C); David R. Staskin, Pfizer (C), GlaxoSmithKline (C), Astellas (C), Watson (C), Allergan (C), American Medical Systems (C); Saad Juma, Coloplast corporation (C), Contura (C); J. Christian Winters, Astellas (C); Jerry G. Blaivas, Navasys Medical (C), Bayer (C), Pfizer (C), Endogun (C); Eric Scott Rovner, Pfizer (C), Allergan (C), Astellas (C), Tengion (C). Investigator: Rodney Appell, Solace, Inc. (C), Novasys Medical, Inc. (C); Roger R. Dmochowski, Allergan (C); Saad Juma, Solace Therapeutics (C), Contura (C), Bioform (C); Eric Scott Rovner, Pfizer (C). Scientific Study or Trial: Eric Scott Rovner, Pfizer, (C), Solace, (C), Contura (C); J. Christian Winters, Solace Thera (U). Meeting Participant or Lecturer: Eric Scott Rovner, Allergan (C); Other: Rodney Appell, American Medical Systems (C), Boston Scientific Corporation (C); Jerry G. Blaivas, HDH (U); Mickey M. Karram, E-Medsco (C), Ethicon Women's Health & Urology(C), Cooper Surgical (C), Astellas (C); Linda E. Whetter, Zola Associates (C).

Back to Article Outline

References 

1. Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004;6:S3
   • View In Article
2. Hampel C, Wienhold D, Benken N, et al. Definition of overactive bladder and epidemiology of urinary incontinence. Urology. 1997;50:4
   • View In Article
   • Abstract
   • Full-Text PDF (1354 KB)
   • CrossRef
3. Hampel C, Artibani W, Espuña Pons M, et al. Understanding the burden of stress urinary incontinence in Europe: a qualitative review of the literature. Eur Urol. 2004;46:15
   • View In Article
   • Abstract
   • Full Text
   • Full-Text PDF (177 KB)
   • CrossRef
4. Leach GE, Dmochowski RR, Appell RA, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence (The American Urological Association). J Urol. 1997;158:875
   • View In Article
   • Abstract
   • Full Text
   • Full-Text PDF (701 KB)
   • CrossRef
5. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21:167
   • View In Article
   • MEDLINE
   • CrossRef
6. Weber AM, Abrams P, Brubaker L, et al. The Standardization of Terminology for Researchers in Female Pelvic Floor Disorders. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12:178
   • View In Article
   • MEDLINE
   • CrossRef
7. Handa VL, Jensen JK, Germain MM, et al. Banked human fascia lata for the suburethral sling procedure: a preliminary report. Obstet Gynecol. 1996;88:1045
   • View In Article
   • MEDLINE
   • CrossRef
8. Elliott DS, Boone TB. Is fascia lata allograft material trustworthy for pubovaginal sling repair?. Urology. 2000;56:772
   • View In Article
   • Abstract
   • Full Text
   • Full-Text PDF (115 KB)
   • CrossRef
9. Flynn BJ, Yap WT. Pubovaginal sling using allograft fascia lata versus autograft fascia for all types of stress urinary incontinence: 2-year minimum followup. J Urol. 2002;167:608
   • View In Article
   • Abstract
   • Full Text
   • Full-Text PDF (68 KB)
   • CrossRef
10. Fitzgerald MP, Mollenhauer J, Bitterman P, et al. Functional failure of fascia lata allografts. Am J Obstet Gynecol. 1999;181:1339
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (384 KB)
    • CrossRef
11. Huang Y, Lin A, Chen K, et al. High failure rate using allograft fascia lata in pubovaginal sling surgery for female stress urinary incontinence. Urology. 2001;58:943
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (123 KB)
    • CrossRef
12. Carbone JM, Kavaler E, Hu JC, et al. Pubovaginal sling using cadaveric fascia and bone anchors: disappointing early results. J Urol. 2001;165:1605
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (841 KB)
    • CrossRef
13. Fitzgerald MP, Mollenhauer J, Brubaker L. Failure of allograft suburethral slings. BJU Int. 1999;84:785
    • View In Article
    • MEDLINE
    • CrossRef
14. Owens DC, Winters JC. Pubovaginal sling using Duraderm graft: intermediate follow-up and patient satisfaction. Neurourol Urodyn. 2004;23:115
    • View In Article
    • MEDLINE
    • CrossRef
15. O'Reilly KJ, Govier FE. Intermediate term failure of pubovaginal slings using cadaveric fascia lata: a case series. J Urol. 2002;167:1356
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (41 KB)
    • CrossRef
16. Clemens JQ, DeLancey JO, Faerber GJ, et al. Urinary tract erosions after synthetic pubovaginal slings: diagnosis and management strategy. Urology. 2000;56:589
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (260 KB)
    • CrossRef
17. Chung SV, Franks M, Smith CP, et al. Technique of combined pubovaginal sling and cystocele repair using a single piece of cadaveric dermal graft. Urology. 2002;59:538
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (126 KB)
    • CrossRef
18. Ulmsten U, Henriksson L, Johnson P, et al. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7:81
    • View In Article
    • MEDLINE
    • CrossRef
19. Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol. 2001;11:1306
    • View In Article
    • MEDLINE
20. Delorme E, Droupy S, de Tayrac R, et al. Transobturator tape (Uratape) (A new minimally invasive method in the treatment of urinary incontinence in women). Prog Urol. 2003;13:656
    • View In Article
    • MEDLINE
21. Delorme E, Droupy S, de Tayrac R, et al. Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol. 2003;45:203
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (193 KB)
    • CrossRef
22. Lightner D, Calvosa C, Andersen R, et al. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere. Urology. 2001;58:12
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (164 KB)
    • CrossRef
23. Mayer RD, Dmochowski RR, Appell RA, et al. Multicenter prospective randomized 52-week trial of calcium hydroxyl apatite versus bovine dermal collagen for treatment of stress urinary incontinence. J Urol. 2007;69:876
    • View In Article
24. Costa P, Motett N, Rabut B, et al. The use of an artificial urinary sphincter in women with type III incontinence and a negative Marshall test. J Urol. 2001;165:1172
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (855 KB)
    • CrossRef
25. Chou EC, Flisser AJ, Panappoulos G, et al. Effective treatment for mixed urinary incontinence with a pubovaginal sling. J Urol. 2003;170:494
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (62 KB)
    • CrossRef
26. Anger JT, Rodriguez LV. Mixed incontinence: stressing about urge. Curr Urol Rep. 2004;5:427
    • View In Article
    • MEDLINE
    • CrossRef
27. Rovner ES, Wright CJ, Messer H. Adherence to the 1997 AUA Guidelines for the surgical treatment of stress urinary incontinence. Urology. 2008;71:239
    • View In Article
    • Abstract
    • Full Text
    • Full-Text PDF (69 KB)
    • CrossRef