The safety of reusing injectable collagen: a multicenter microbiological study.

We have previously reported pilot data regarding the safety of saving partially used syringes of a glutaraldehyde cross-linked collagen for use in subsequent treatment sessions with the same individual. That single institution study involved 56 partially used syringes cultured for aerobic bacteria. Only one weakly positive culture was detected among these 56 samples, which prompted us to carry out this expanded study involving multiple centers and different injection techniques. Samples were collected from four centers. Following periurethral injection in an office setting, 166 partially used syringes of glutaraldehyde cross-linked collagen were refrigerated for between 1 and 104 weeks (average 58). Material from all 166 syringes was then cultured qualitatively and quantitatively for both aerobic and anaerobic organisms. Collagen from one syringe grew >100,000 colonies of Escherichia coli. All other cultures were negative. In the pilot study, one culture of 56 syringes was weakly positive for coagulase-negative staphylococcus. When the results from both studies were considered together, only two of 222 partially used syringes (0.9%) were contaminated. The background risk of local infection associated with periurethral collagen injection is approximately 0.29%. Using the statistical equation 'number needed to harm', we found that a clinician would have to reuse 111 syringes at a saving of $34,965 before he or she would cause a single local injection by so doing. Therefore, we feel that it may be cost-effective and safe to reinject material from a partially used syringe of glutaraldehyde cross-linked collagen during a subsequent treatment session on an individual.

Urethral instability: clinical and urodynamic characteristics.

Filling cystometry was performed on 397 patients with lower urinary tract complaints. The overall prevalence of urethral instability was 12.6% (50/397). Of these 187 patients had detrusor instability (DI). Within the DI group, clinical and urodynamic characteristics were compared. Patients with an unstable urethra had a shorter functional urethral length (P = 0.005). For those with DI, 28 of 187 (15%) had urethral instability. Forty (21%) women had a decrease in maximal urethral pressure that preceded the detrusor contraction (type II DI). When those with type II DI were excluded, the difference in functional urethral length was not observed. Patients with type II DI experienced an earlier sensation of fullness of 228 mL compared with 283 mL for the other patients with DI (P = 0.001). There was a positive association between urethral instability and type II DI. Four different patterns of urethral pressure changes were observed. Based on these findings, it appears that a urethral abnormality may be the primary disorder in patients with type II DI. The differentiation of the various subtypes of urethral instability and DI might be important for directing therapy.

Correlation of symptoms with location and severity of pelvic organ prolapse.

OBJECTIVE: The purpose of this study was to compare the symptoms that are related to pelvic floor dysfunction with the location and severity of the coexisting prolapse. STUDY DESIGN: Two hundred thirty-seven consecutive patients with symptomatic pelvic organ prolapse came to Johns Hopkins Medicine during a 24-month period beginning in July 1998 and completed a symptom-specific Likert scale questionnaire that included standardized questions that were compiled from commonly used validated instruments. All questionnaires were completed by the patients before they were seen by a physician. Further evaluation included a standardized physical examination that included the International Continence Society's system for grading uterovaginal prolapse. Symptoms were categorized according to both severity and associated anatomic compartment. Symptoms that were related to urinary and anal incontinence and voiding, defecatory, sexual, and pelvic floor dysfunction were analyzed with respect to location and severity of pelvic organ prolapse with the use of the nonparametric correlation coefficient, Kendall's tau-b. RESULTS: The mean age of the women was 57.2 years (range, 23-93 years); 109 of the women (46%) had undergone hysterectomy. Overall, stage II was the most common pelvic organ prolapse (51%) that was encountered. In 77 patients (33%), anterior compartment pelvic organ prolapse predominated; 46 patients (19%) demonstrated posterior compartment prolapse, whereas 26 patients (11%) had apical prolapse. In 88 patients (37%), no single location was more severe than another. Voiding dysfunction that was characterized by urinary hesitancy, prolonged or intermittent flow, and a need to change position was associated with the increasing severity of anterior and apical pelvic organ prolapse. Pelvic pressure and discomfort along with visualization of prolapse were strongly associated with worsening stages of pelvic organ prolapse in all compartments. Defecatory dysfunction characterized by incomplete evacuation and digital manipulation was associated with worsening posterior compartment pelvic organ prolapse. Impairment of sexual relations and duration of abstinence were strongly associated with worsening pelvic organ prolapse. An inverse correlation was observed between increasing severity of pelvic organ prolapse and urinary incontinence and enuresis. CONCLUSION: Women with pelvic organ prolapse experience symptoms that do not necessarily correlate with compartment-specific defects. Increasing severity of pelvic organ prolapse is weakly to moderately associated with several specific symptoms that are related to urinary incontinence and voiding, defecatory, and sexual dysfunction.

Collagen implant for treating stress urinary incontinence in women with urethral hypermobility.

PURPOSE: We evaluated the use of collagen in women with stress urinary incontinence and urethral hypermobility. MATERIALS AND METHODS: We treated 90 patients with stress urinary incontinence and urethral hypermobility with 1 to 3 injections of Contigen implant (C. R. Bard, Inc., Covington, Georgia) between June 1996 and October 1998. Observations at 3, 6 and 12 months included continence grade, 7-day voiding diaries and quality of life questionnaires. Abdominal leak point pressure was determined at baseline and 12 months. RESULTS: At the 6-month followup 68 patients remained in the study, of whom 30 (44%) were dry and 24 (35%) were improved. Of the 58 patients who reached the 12-month followup 19 (33%) were dry and 19 (33%) were improved. Considering all patients entered into the study at 6 months 30 (33%) were dry and 24 (27%) were improved. Of the original 90 patients 19 (21%) were dry and 19 (21%) were improved at 12 months. The probability of maintaining initial improvement for 12 months was 44%. The success of bulking agent therapy was not predicted by the initial incontinence grade. Improved continence grade correlated with improved leak point pressure. CONCLUSIONS: This therapy is appropriate in women with urethral hypermobility who wish to avoid surgical risks and in those in whom surgery is ill advised.

Uterosacral ligament: description of anatomic relationships to optimize surgical safety.

OBJECTIVE: To determine the optimal site in the uterosacral ligament for suspension of the vaginal vault with regard to adjacent anatomy and suspension strength. METHODS: Fifteen female cadavers were evaluated between December 1998 and September 1999. Eleven hemisected pelves were dissected to better define the uterosacral ligament and identify adjacent anatomy. Ureteral pressure profiles with and without relaxing incisions were done on four fresh specimens. Suture pullout strengths also were assessed in the uterosacral ligament. RESULTS: The uterosacral ligament was attached broadly to the first, second, and third sacral vertebrae, and variably to the fourth sacral vertebrae. The intermediate portion of the uterosacral ligament had fewer vital, subjacent structures. The mean +/- standard deviation distance from ureter to uterosacral ligament was 0.9 +/- 0.4, 2.3 +/- 0.9, and 4.1 +/- 0.6 cm in the cervical, intermediate, and sacral portions of the uterosacral ligament, respectively. The distance from the ischial spine to the ureter was 4.9 +/- 2.0 cm. The ischial spine was consistently beneath the intermediate portion but variable in location beneath the breadth of the ligament. Uterosacral ligament tension was transmitted to the ureter, most notably near the cervix. The cervical and intermediate portions of the uterosacral ligament supported more than 17 kg of weight before failure. CONCLUSION: Our findings suggest that the optimal site for fixation is the intermediate portion of the uterosacral ligament, 1 cm posterior to its most anterior palpable margin, with the ligament on tension.

Treatment of intrinsic sphincter deficiency using autologous ear chondrocytes as a bulking agent.

Intrinsic sphincter deficiency (ISD) is frequently treated with collagen bulking at the bladder neck. The standard material used, Contigen, biodegrades over 3-19 months requiring repeated injections to maintain efficacy. The study objective was to evaluate use of autologous ear chondrocytes for treatment of ISD. Women with documented ISD had harvest of auricular cartilage. Chondrocytes were isolated from the cartilage and expanded in culture and formulated with calcium alginate to form an injectable gel. Thirty-two patients received a single outpatient injection just distal to the bladder neck. Outcome measures included voiding diary, quality-of-life scores, incontinence severity grading, and pad weight testing. Incontinence grading indicated 16 patients dry, and 10 improved at 12 months for a total of 26 of 32 (81.3%) dry and improved after one treatment. Only four patients had a 12-month pad weight test over 2.2 g. Quality-of-life scores improved significantly after treatment. There was a decrease in incontinence impact scores in all categories. The urogenital distress inventory declined for all categories except bladder emptying and lower abdominal pain. Endoscopic treatment of ISD with autologous chondrocytes is safe, effective, and durable with 50 % of patients dry 12 months after one injection. Twenty-six of 32 patients dry or improved at 3 months after the injection maintained the effect at the 12-month visit.

Leak-point pressure: clinical application of values at two different volumes.

A prospective analysis of 306 consecutive patients with genuine stress incontinence was performed to evaluate the clinical usefulness of additional leak-point pressure (LPP) determination at 200 ml. LPP values at both volumes were compared to maximal urethral closure pressure (MUCP) in an attempt to determine a critical cut-off value for the detection of a low MUCP (< or =20 cmH2O). A positive LPP at 150 ml was found in 157 patients. The mean LPP for patients with a low MUCP was 58.5 cmH2O compared to 71.6 for those with a normal MUCP, which was statistically significant (p = 0.01). The correlation coefficient between LPP and MUCP was 0.317. A negative LPP was found in 30% (24/79) of the total having a low MUCP. The addition of values for LPP at 200 ml resulted in an increase in the number who leaked to 191, a 50% increase in the detection rate of low MUCP and a statistically significant relationship between LPP < or =60 cmH2O and low MUCP. Various critical cut-off values for LPP demonstrated good specificity but poor sensitivity for the detection of a low MUCP. It was concluded that there was a statistically significant relationship between LPP and MUCP. Performing LPP at 200 ml provides additional clinically useful diagnostic information.

Randomized trial of antibiotic prophylaxis for combined urodynamics and cystourethroscopy.

OBJECTIVE: To determine the efficacy of prophylactic nitrofurantoin in preventing bacteriuria after urodynamics and cystourethroscopy. METHODS: We assumed that nitrofurantoin prophylaxis would decrease the rate of infection after urodynamics and cystourethroscopy from 19% to 5%. All women presenting for urodynamics and cystourethroscopy during a 27-month period were offered enrollment, and 142 were randomly assigned to receive two doses of long-acting nitrofurantoin 100 mg (n = 74), or two doses of placebo (n = 68). Nitrofurantoin and placebo capsules were identical, and subjects and physicians were masked to group assignment. Differences were assessed using Student t test for continuous data and chi2 analysis for dichotomous data. RESULTS: There were no statistical differences in demographic characteristics or final diagnoses between groups. Seven women (5%) who had bacteriuria on initial urine culture were not included in the final analysis. The frequency of bacteriuria in the postinstrumentation urine cultures was 6% overall, 7% in the treatment group, and 5% in the controls, a nonsignificant difference ([relative risk] 1.49, [confidence interval] 0.37, 5.95). The power of the study was 33% to detect a significant difference. CONCLUSION: Bacteriuria after combined urodynamics and cystourethroscopy was not improved by a 1-day course of nitrofurantoin.

Clinical and urodynamic predictors of delayed voiding after fascia lata suburethral sling.

OBJECTIVE: To determine the time to resumption of normal voiding after a fascia lata sling and whether any clinical, operative, or urodynamic variables predict it. METHODS: Between January 1993 and September 1996, 62 women underwent fascia lata suburethral sling operations for intrinsic sphincter deficiency or recurrent stress incontinence. The demographic, operative, and urodynamic data of 61 of these patients were analyzed. RESULTS: The mean number of days to resumption of normal voiding was ten. Three patients (5%) developed permanent retention. Patients 65 years and older were more likely than younger patients to have prolonged catheterization (16 versus 7 days, P=.008). Women who had additional procedures voided at a mean of 15 days compared to nine days for those having slings only (P=.029). A preoperative urine flow rate less than 20 mL/sec was associated with late voiding. There was no significant relationship between preoperative voiding mechanism and voiding time. CONCLUSION: Resumption of normal voiding occurred earlier than reported by others. Age over 65 years, additional surgical procedures, and low peak flow rates were risk factors for delayed voiding. Time to normal voiding was independent of the preoperative voiding mechanism.

Suburethral abscess: a complication of periurethral collagen injection therapy.

BACKGROUND: Urinary tract infection after collagen injection is well documented. Other adverse reactions are rare. CASES: Three women experienced suburethral abscess after repeat periurethral injections. All patients received local skin preparation and postprocedural antibiotics. Symptoms failed to resolve with antibiotics. The first two patients presented after 5 weeks and 10 days with irritative voiding symptoms and a tender suburethral swelling. The first patient was treated with excision. Spontaneous rupture into the urethra occurred with the second. The third woman presented with acute urinary retention at 102 days. A large suburethral mass was drained successfully in the office. CONCLUSION: Suburethral abscess may be a delayed complication of periurethral collagen injections, not preventable by postprocedural antibiotics. Drainage is required.

Fascia lata suburethral sling vs. Burch retropubic urethropexy. A comparison of morbidity.

OBJECTIVE: To compare morbidity from the fascia lata sling to that from the Burch procedure. STUDY DESIGN: The charts of 64 consecutive patients undergoing the two procedures were reviewed for perioperative, immediate postoperative and delayed postoperative complications. RESULTS: Mean age was significantly older and prior surgery more common in the sling group, but parity and weight were comparable for the two groups. Operative time, estimated blood loss, change in hematocrit, incidence of transfusion, use of narcotics and hospital stay were not statistically different. Duration of catheter use was 2.2 days longer in the sling group (8.96 vs. 6.75 days, P = .387). Comparison of the sling vs. Burch, respectively, showed persistent urge incontinence in 42.8% and 40.0%, new urge incontinence in 22.2% and 16.6%, and cystotomy in 11% and 0%. CONCLUSION: The fascia lata sling procedure has morbidity comparable to that of Burch retropubic urethropexy. Urge incontinence needs to be specifically addressed preoperatively in both groups of patients.

Supine empty stress test as a predictor of low valsalva leak point pressure.

Our objective was to determine whether a positive supine empty stress test is predictive of a low Valsalva leak point pressure (< or =60 cm of water). Evaluation was carried out on 179 patients with a history of genuine stress incontinence confirmed with urodynamic testing. All patients had a supine stress test performed after voiding. Residual urine determinations were all <100 cc. A vesical Valsalva leak point pressure determination (cough and strain) was performed during multichannel urodynamics with 150 cc in the bladder. Urethral profilometry was performed at maximum capacity. There was a statistically significant relationship between a low leak point pressure and a positive supine empty stress test (P < 0.000). The supine empty stress test had a sensitivity of 79% and a specificity of 62.5% for the detection of a low leak point pressure. The negative predictive value was high at 90%. For the age group 50 years and younger the negative predictive value was 95%. However, there was no significant relationship between a positive supine empty stress test and a low maximal urethral closure pressure. We conclude that the supine empty stress test is a useful screening test for a low leak point pressure but not a low urethral closure pressure. Its high negative predictive value is useful in excluding the presence of a low leak point pressure and may help the clinician to determine which patients with genuine stress incontinence need further assessment of the dynamic function of the urethral sphincter.

Surgical management of urinary incontinence.

Surgery for stress incontinence is selected according to specific problems in each patient. Patients with ISD can be identified and selected for sling surgery or collagen injection therapy. Other patients may be managed successfully by retropubic urethropexy, either open or laparoscopic. Diagnostic evaluation should be thoughtful and extensive, with good correlation of findings and presenting symptoms to apply therapy in a specific manner to each patient.

Portable ultrasound determination of urinary residual volume.

A portable ultrasound to determine bladder volume, the BladderScan 2500, was compared to transurethral catheterization in 72 women. Most measurements were made after voiding. Volumes measured by catheterization were 17 ml greater than those measured by ultrasound, which was not clinically significant. The BladderScan technique does not carry the risk of urinary tract infection or patient trauma, and patient dignity is preserved, while accurately determining urinary volume.

Sling incision with associated vaginal wall interposition for obstructed voiding secondary to suburethral sling procedure.

Obstructed voiding is a well recognized complication following a suburethral sling procedure. Current methods of transvaginal and transabdominal urethrolysis have had variable success rates in relieving the obstruction, and do not restabilize the urethra to prevent potential postoperative stress incontinence. We report on a procedure used in 4 cases which addresses both of these issues. All patients had persistent urinary retention beyond 8 weeks after a suburethral sling procedure. An oupatient procedure consisting of sling incision and associated tissue interposition (vaginal wall in three cases and fascia lata in one) was successful in relieving the obstruction. Continence status was maintained in 3 of the 4 patients. There were no major complications of this outpatient procedure.

The contribution of urethrocystoscopy to evaluation of lower urinary tract dysfunction in women.

The aim of this study was to determine whether the evaluation of lower urinary dysfunction with urodynamics and urethrocystoscopy provides unique information that is missed by urodynamics alone. Eighty-four women underwent multichannel urodynamics and urethrocystoscopy. Retrospective analysis included evaluation of the relationships between lower urinary tract lesions and risk factors using chi2 and Fisher's exact tests. Urethrocystoscopic findings changed the diagnosis and management in 6 patients. New urethrocystoscopic findings included papillary transitional-cell carcinoma, cystitis glandularis, an intravesical suture and a urethral diverticulum. Clinical parameters were not predictive of these findings. Urethrocystoscopic findings also contributed to the final diagnosis in 10 patients with intrinsic sphincter deficiency. Considered alone, maximum urethral closure pressure < or =20 cmH2O had a sensitivity of only 20% and a positive predictive value of 40% for this diagnosis. Urodynamics without urethrocystoscopy would have missed important diagnoses in 19% of women. Urethrocystoscopy and urodynamics complement one another, and both have a role in the evaluation of women with lower urinary tract dysfunction.

Evaluation of pressure transmission ratios in women with genuine stress incontinence and low urethral pressure: a comparative study.

OBJECTIVE: To determine whether women with genuine stress incontinence and low urethral closure pressure (20 cm H2O or lower) had more severely impaired pressure transmission to the urethra than women with stress incontinence and normal urethral pressures. METHODS: Seventy-six women who underwent multichannel urodynamic testing were included for comparative analysis. They were classified into the following groups: genuine stress incontinence with low urethral pressure (N = 20), genuine stress incontinence without low urethral pressure (N = 32), and continent controls (N = 24). Urodynamic indices and pressure transmission ratios were calculated from static and stress urethral pressure profiles, respectively. Multiple demographic cofactors, urethral mobility, and previous surgeries were correlated for associations with urodynamic results. RESULTS: Women with stress incontinence and low urethral pressure were significantly older (57.6 years, P < .0071). There were no differences with regard to urethral mobility and previous surgeries. Mean maximum urethral closure pressure and the distance from the proximal margin of the urethra to the point of maximum urethral closure pressure were statistically less in women with low urethral pressure. There were no differences in pressure transmission ratios between any of the study groups. CONCLUSION: Because there are no differences in pressure transmission ratios between women with genuine stress incontinence with and without low urethral closure pressure, the higher risk for surgical failure with low urethral pressure appears to result from another pathophysiologic process.

Tissue reaction to expanded polytetrafluoroethylene suburethral sling for urinary incontinence: clinical and histologic study.

OBJECTIVE: The use of expanded polytetrafluoroethylene suburethral sling for recurrent urinary incontinence has shown an excellent cure rate but a number of complications. This study was designed to evaluate patients who had tissue reaction or removal of the sling, to determine potential causes, clinical course, and eventual outcome. STUDY DESIGN: A retrospective review of consecutive charts was completed for 115 patients who had suburethral sling surgery with expanded polytetrafluoroethylene. Patients having tissue reaction or removal of sling material were identified, and eight removed sling specimens were analyzed histologically with Milligan's trichrome, hematoxylin and eosin, fibrin, Brown-Brenn bacteria, and Dahl's calcium stains. RESULTS: Twenty-four patients had reactions to the sling material, and 23 slings were eventually removed. Seventeen of 23 patients having sling removal remained continent. Histologic evaluations revealed gram-positive cocci in all expanded polytetrafluoroethylene patch interstices. Fibrous tissue, fibroblasts, and collagen were present in one half of specimens. CONCLUSION: There is a 23% reaction or removal rate for expanded polytetrafluoroethylene suburethral sling procedures. Seventeen of 23 patients remained continent in spite of sling removal. Histologic studies showed gram-positive cocci in the patch interstices, although prophylactic antibiotic coverage did not prevent infection and cultures from the vaginal or abdominal reaction sites did not reveal a significant growth of organisms. Patients need to be aware of the high complication rate for this suburethral sling procedure, and physicians need to work further to modify sling materials and techniques to reduce complications.