Aaron Kirkemo

Urinary retention after tension-free vaginal tape procedure: incidence and treatment

OBJECTIVES To review our experience with persistent urinary retention after the tension-free vaginal tape (TVT) procedure and report our treatment results. Ulmsten recently introduced the TVT procedure for female stress urinary incontinence. Although the morbidity is minimal, no surgical procedure is without risks, and experience will better define the morbidity of the TVT procedure. METHODS Since November 1998, we have collectively performed 600 TVT procedures. Of these, 17 patients (2.8%) developed urinary retention or symptoms consistent with obstruction (including hesitancy, straining to void, or feeling of incomplete emptying) lasting more than 1 week from the date of the procedure. We reviewed the operative record, noting the operative time, estimated blood loss, presence of bladder penetration, and any reported complications. All 17 patients subsequently underwent transvaginal release on an outpatient basis. RESULTS Seventeen patients (mean age 56 years, range 38 to 81) underwent sling release a mean of 64 days (range 6 to 228) after the TVT procedure. All patients voided to completion within 24 hours of release and reported no further subjective complaints of outlet obstruction. None of the subjects reported de novo urge incontinence or urgency. In each patient, the estimated blood loss was minimal; the operative time averaged 15 minutes. One urethral injury occurred and was managed intraoperatively without sequelae. Sixteen patients who underwent sling release have remained dry; the remaining patient, in whom a urethral injury was repaired, redeveloped stress incontinence and underwent an uncomplicated successful transvaginal sling procedure. CONCLUSIONS Outlet obstruction is a risk of the TVT procedure and occurred with an incidence of 2.8% in our experience. The TVT mesh can be released by a simple vaginal incision under local anesthesia with rapid return to normal voiding. Although the number of patients studied was small, stress incontinence did not recur after uncomplicated release in our series.

SUCCESS RATE OF MODIFIED PEREYRA BLADDER NECK SUSPENSION DETERMINED BY OUTCOMES ANALYSIS

The reported success rates of the modified Pereyra bladder neck suspension vary from 51 to 90%. Retrospective chart review studies have reported cure rates of 77 to 90%. In contrast, a questionnaire based outcomes analysis, using a strict definition of cure, reported 51% of the patients to be cured of stress urinary incontinence after modified Pereyra bladder neck suspension. We conducted a questionnaire based outcomes analysis of the modified Pereyra bladder neck suspension at our institution. The objectives of the study were to determine the success rates of this procedure using strict criteria in an outcomes analysis format, assess the overall satisfaction of patients postoperatively and identify historical factors that may be predictive of outcome. Between September 1988 and December 1991, 151 patients underwent a modified Pereyra bladder neck suspension for urodynamically documented genuine stress urinary incontinence. Mean patient age was 56 years (range 19 to 82 years) and mean followup was 25 months (range 9 to 45). All patients had type 2 incontinence (anatomical) based on history (severity of symptoms), physical examination, and fluoroscopic assessment of the bladder neck and urethra. Preoperative pad use, and irritative and obstructive symptoms were retrospectively assessed, and a preoperative Stamey incontinence score was assigned. A standardized questionnaire was used to compare preoperative and postoperative voiding symptoms, perception of urinary control and satisfaction with the decision to undergo an operation. Followup telephone calls were made by a trained registered nurse not associated with the original procedure. Postoperative pad use also was quantified and a postoperative Stamey score was assigned. A total of 106 patients (70%) returned the questionnaires. Cure was strictly defined as no urine leakage under any circumstance. While 78% of the patients required no to minimal protection postoperatively, 50 (47%) reported cure of the stress urinary incontinence, 68 (64%) reported subjective improvement, 27 (26%) were the same and 11 (10%) were subjectively worse after modified Pereyra bladder neck suspension. Of the patients 77% were satisfied with the decision to undergo the operation. Patients subjectively worse were significantly older than those subjectively improved (66 versus 54 years, p = 0.05). Postoperative failures had significantly higher obstructive and irritative symptom scores. Questionnaire based outcomes analysis has consistently demonstrated success rates less than those reported in retrospective chart review studies. Outcomes analysis, based on patient assessment of satisfaction, may more accurately reflect the expected surgical outcome after a modified Pereyra bladder neck suspension. We emphasize the need for standardized questionnaires and outcomes analysis to evaluate patient satisfaction with surgery designed to improve quality of life.

The effect of study methodology on reported success rates of the modified Pereyra bladder neck suspension

PURPOSE We compared surgical results in a cohort of women after modified Pereyra bladder neck suspension using questionnaire based outcomes analysis versus a retrospective chart review. MATERIALS AND METHODS Of 151 patients who underwent modified Pereyra bladder neck suspension 102 had complete questionnaire and chart data for review. Mean patient age was 56 years and followup was 25 months. RESULTS According to outcomes analysis 48 patients (47.1%) were cured and in 65 (64%) stress urinary incontinence improved compared to 74 (72%) cured and 89 (89%) improved by retrospective review. Of the 102 chart review patients 10 (9%) reported daily pad use compared to 55 of the 102 (53%) in the questionnaire study. CONCLUSIONS This study controls for patient selection, definition of cure and length of followup, and demonstrates that study methodology profoundly affects reported outcomes for the modified Pereyra bladder neck suspension.

Associations among urodynamic findings and symptoms in women enrolled in the Interstitial Cystitis Data Base (ICDB) Study.

OBJECTIVES The goal of this study was to correlate the cystometric findings with the presenting symptoms of the 388 women enrolled in the NIH/NIDDK-funded interstitial Cystitis Data Base (ICDB) Study as of December 31, 1995. METHODS All patients underwent a complete history and physical and completed standardized questionnaires to assess voiding symptoms and quality of life (QOL). A 3-day voiding log was also obtained, followed by a baseline urodynamic exam. All results are expressed as mean values +/- 1 standard deviation, and all reported correlations were significant. RESULTS A correlation was seen between reported daytime, nighttime, and 24-hour frequency, and both volume at first sensation to void (VFSV) and maximal cystometric capacity (VMCC). Patients with constant severe urgency had smaller VFSV, 63 +/- 59 mL versus 108 +/- 90 mL, and lower VMCC, 163 +/- 102 mL versus 288 +/- 135 mL, than patients without the complaint. A negative trend was seen for both VFSV and VMCC versus the global severity. An inverse trend was seen between minimal and maximal pain scores over the 4 weeks before the exam and VMCC. (No correlation existed between current pain noted during baseline screening visits and VFSV or VMCC). No urodynamics correlates were seen with global measures of body pain and global health. Uninhibited detrusor contractions (UDCs) were seen in 56 of 384 patients (14.6%). A positive correlation was seen between urgency symptoms and the presence of UDCs. Correlations between the VFSV and VMCC were made with both the average voided volume (AVV) and the average maximal voided volume (AMVV) as determined by a 3-day voiding log. Significant positive correlations were seen with each pair-wise comparison (P = 0.001). CONCLUSION These findings confirm that subjective measurements of symptoms associated with interstitial cystitis can be confirmed objectively with urodynamic studies.

Questionnaire-Based Outcomes Study of Nononcological Post-Vasectomy Complications

PURPOSE We conducted an outcomes analysis to determine the incidence of post-vasectomy complications. MATERIALS AND METHODS A questionnaire (154 questions) addressing post-vasectomy complications, incidence of post-vasectomy scrotal pain and quality of life issues was sent to 470 patients. Followup telephone surveys were made. RESULTS A total of 182 patients (42.3%) responded. Mean follow-up was 4.8 years. The most common complication was post-vasectomy scrotal pain in 34 men (18.7%), which adversely affected the quality of life in 4 (2.2%). In retrospect, 71.4% of the men were satisfied with the decision for vasectomy, 19.3% had equivocal feelings and 9.3% were dissatisfied. CONCLUSIONS Chronic scrotal pain is the most common post-vasectomy complication that may adversely affect quality of life in men undergoing vasectomy.

Lack of correlation of the American Urological Association Symptom 7 Index with urodynamic bladder outlet obstruction.

The objective of this study is to assess whether subjective information from the American Urological Association (AUA) Symptom 7 Index correlates with or predicts objective urodynamic parameters of bladder outlet obstruction.

Intravesical thiotepa-induced eosinophilic cystitis

Eosinophilic cystitis is a rare form of an allergic cystitis. Factors such as food allergens, parasites, and drugs have been implicated in the genesis of eosinophilic cystitis. Associated risk factors include bronchial asthma, atopic diseases, and environmental allergens. Intravesical mitomycin is a reported causative agent. We report the first case of eosinophilic cystitis that developed after intravesical instillation of thiotepa for treatment of superficial bladder cancer.

The TVT Worldwide Observational Registry for Long-Term Data: Safety and Efficacy of Suburethral Sling Insertion Approaches for Stress Urinary Incontinence in Women

PURPOSE We examined the clinical effectiveness of a single incision sling in women with stress urinary incontinence and obtained comparative perioperative and postoperative data on retropubic and transobturator slings. MATERIALS AND METHODS Women who underwent a cough stress test were treated with surgery using a single incision, retropubic or obturator sling (Gynecare® TVT SECUR™, TVT™ or TVT Obturator System, respectively) with the choice of sling based on surgeon preference. Objective cure was assessed by the standing cough stress test at 1 year. Subjective outcomes were assessed by the Incontinence Quality of Life Questionnaire and EQ-5D™. Perioperative data and return to normal activity were recorded. RESULTS Of the 1,398 women who underwent surgery there were postoperative data on 1,334, including 32.8%, 17.8% and 49.4% who received a tension free vaginal tape, obturator tension free vaginal tape and SECUR, respectively. After obturator tension free vaginal tape surgery fewer women had a positive cough stress test than after TVT and SECUR surgery (4 of 110 or 3.6% vs 24 of 187 or 12.8% and 59 of 374 or 15.8%, respectively). Incontinence Quality of Life Questionnaire effect size was 1.87, 1.42 and 1.56, respectively, indicating a large treatment effect. Using our Incontinence Quality of Life Questionnaire response definition 85.4%, 79.0% and 85.2% of the TVT, TVT outside-in obturator system and SECUR cohorts, respectively, were treatment responders (p = 0.11).The SECUR cohort had the shortest operative time, the lowest proportion of women who required an overnight stay and the most women who underwent surgery under local anesthesia. Median time to return to employment, housework, sex life and hobbies was most rapid for SECUR. CONCLUSION This registry demonstrates the high effectiveness of all 3 approaches. The single incision sling appeared to have objective and subjective efficacy similar to that of the retropubic sling and it can be performed under local anesthesia in an office environment.

Recruitment for a clinical trial of drug treatment for benign prostatic hyperplasia

OBJECTIVES To evaluate the effectiveness of various recruitment strategies for a 6-year multicenter clinical trial of medical therapy for benign prostatic hyperplasia, the Medical Therapy of Prostatic Symptoms Trial. METHODS How participants learned about the trial was obtained during initial contact with clinical centers and at the first screening visit. The yield of randomized participants from the initial contact and first screening visit was calculated for each of the recruitment techniques. RESULTS During a period of 28 months, 16,723 potential trial participants made an initial contact with the 17 clinical centers, and 2931 men were randomized. An average of four initial contacts were required for each first screen visit and six per randomized participant. Newspaper (29.9%) and mail (26.7%) were the two leading sources of randomized participants. Medical sources (9.6%), radio (8.8%), and newsletters (8.4%) were also important sources. All clinical centers achieved or exceeded their recruitment goals. CONCLUSIONS Mass mail and newspaper were the most effective recruitment techniques to enlist the interest of men with urinary symptoms for a long-term trial of drug therapy for benign prostatic hyperplasia.