Steven D. Kleeman

Complications and untoward effects of the tension-free vaginal tape procedure.

OBJECTIVE To report our experience with our first 350 cases of tension-free vaginal tape (TVT), specifically assessing intraoperative complications, postoperative morbidity, and untoward effects of the procedure. METHODS Although increased numbers of reports have documented the efficacy of the TVT procedure, there are minimal data about the incidence of complications and how they are managed. We performed a retrospective review of all patients undergoing the TVT procedure over a 4-year period to report intraoperative complications (bladder perforation and excessive bleeding), postoperative complications (de novo urge incontinence, voiding dysfunction, erosion, nerve injury, urinary retention, hematoma formation), and incidence of reoperation either for voiding dysfunction or for recurrent incontinence. RESULTS A total of 350 patients were included in the study. Fifty-five percent (194) of women underwent the TVT procedure in conjunction with other vaginal surgery, and 45% (156) underwent the TVT alone. Seventy women (20%) had previous antiincontinence surgery. Intraoperative complications included 19 bladder perforations in 17 patients (4.9%) and three cases of significant bleeding (0.9%). Postoperatively, 17 women (4.9%) had voiding dysfunction and 42 (12%) required anticholinergic therapy beyond 6 weeks. Recurrent urinary tract infections developed in 38 (10.9%), erosion or poor healing in three (0.9%), hematoma in six (1.7%), and nerve injury in three (0.9%). Twenty-eight (8%) underwent urethral dilation in the postoperative period for varied amounts of voiding dysfunction. Of these, 82% were either improved or were cured. Six women (1.7%) underwent a takedown of the TVT procedure for continued voiding dysfunction, and two of these (33%) developed recurrent stress incontinence. To date, two patients (0.5%) have undergone another procedure for recurrent or persistent stress incontinence. CONCLUSION The TVT procedure is efficacious for the correction of stress incontinence. Our data show that it is a safe procedure with an acceptable complication rate when performed by surgeons who have experience with retropubic and transvaginal antiincontinence procedures.

Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: A randomized controlled trial

OBJECTIVE: To compare the safety and efficacy of the transobturator tape to tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence in patients with and without concurrent pelvic organ prolapse. METHODS: One-hundred seventy women with urodynamic stress incontinence, including those with and those without pelvic organ prolapse, from three academic medical centers were randomized to receive TVT or transobturator tape. Subjects with detrusor overactivity or previous sling surgery were excluded. The primary outcome was the presence or absence of abnormal bladder function, a composite outcome defined as the presence of any the following: incontinence symptoms of any type, a positive cough stress test, or retreatment for stress incontinence or postoperative urinary retention assessed 1 year after surgery. This study is a noninferiority study design. RESULTS: Of 180 women who enrolled in the study, 170 underwent surgery and 168 returned for follow-up, with a mean follow-up of 18.2±6 months. Mean operating time, length of stay, and postoperative pain scores were similar between the two groups. Bladder perforations occurred more frequently in the TVT group (7% compared with 0%, P=.02); otherwise, the incidence of perioperative complications was similar. Abnormal bladder function occurred in 46.6% of TVT patients and 42.7% of transobturator tape patients, with a mean absolute difference of 3.9% favoring transobturator tape (95% confidence interval –11.0% to 18.6%.). The P value for the one-sided noninferiority test was .006, indicating that transobturator tape was not inferior to TVT. CONCLUSION: The transobturator tape is not inferior to TVT for the treatment of stress urinary incontinence and results in fewer bladder perforations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00475839 LEVEL OF EVIDENCE: I

Prevalence of persistent and de novo overactive bladder symptoms after the tension-free vaginal tape

OBJECTIVE: The purpose of this study was to assess 1) the proportion of de novo urge incontinence and overactive bladder symptoms after a tension-free vaginal tape (TVT), and 2) the natural history of preoperative urge incontinence and overactive bladder symptoms after a TVT. METHODS: A chart review was performed on all patients who underwent a TVT without concomitant procedures from November 1998 to November 2002. Preoperative and postoperative stress and mixed urinary incontinence symptoms as well as overactive bladder symptoms were assessed subjectively, as was the use of anticholinergics to treat overactive bladder symptoms. Two preoperative and postoperative validated quality-of-life questionnaires, the Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6), were also compared. RESULTS: Ninety-eight patients were included in the study. Postoperatively, de novo urge incontinence symptoms developed in 9.1%, de novo overactive bladder symptoms developed in 4.3%, and 8.7% started taking anticholinergics for the first time. After a TVT, the urge component resolved in 63.1% of those with preoperative symptoms of mixed incontinence, overactive bladder symptoms resolved in 57.3% of those with preoperative overactive bladder symptoms, and 57.7% of those who used anticholinergics preoperatively no longer needed to do so. There was also a statistically significant improvement in comparing the preoperative and postoperative IIQ-7 and UDI-6 scores. CONCLUSION: The proportion of patients in whom de novo overactive bladder or urge incontinence symptoms developed postoperatively is low, and approximately 57% of patients with preoperative overactive bladder symptoms can expect resolution of these symptoms after a TVT.

Uterosacral ligament vault suspension: five-year outcomes.

OBJECTIVE: To evaluate the five-year anatomic and functional outcomes of the high uterosacral vaginal vault suspension. METHODS: One hundred ten patients with advanced symptomatic uterovaginal or posthysterectomy prolapse treated between January 1997 and January 2000 were identified and 72 (65%) consented to participate in this study. Anatomic outcomes were obtained by Pelvic Organ Prolapse Quantification. Functional results were obtained subjectively and with quality-of-life questionnaires, including the short-form Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI), and Female Sexual Function Index. RESULTS: The mean follow-up period was 5.1 years (range 3.5–7.5 years). Vaginal hysterectomy (37.5%), anterior colporrhaphy (58.3%), posterior colporrhaphy (87.5%), and suburethral slings (31.9%) were performed as indicated. Surgical failure (symptomatic recurrent prolapse of stage 2 or greater in one or more segments) was 11 of 72 (15.3%). Two patients (2.8%) had recurrence of apical prolapse of stage 2 or greater. For those sexually active preoperatively and postoperatively (n=34), mean postoperative Female Sexual Function Index scores for arousal, lubrication, orgasm, satisfaction, and pain were normal, whereas the desire score was abnormal (mean= 3.2). However, 94% (n=29) were currently satisfied with their sexual activity. Postoperative IIQ/UDI scores were significantly improved in all three domains (irritative, P= .01; obstructive, P<.001; stress, P=.03) and overall (IIQ-7, P<.001; UDI, P<.001) compared with preoperatively. Bowel dysfunction occurred 33.3% preoperatively compared with 27.8% postoperatively (P=.24). CONCLUSION: Uterosacral ligament vaginal vault fixation seems to be a durable procedure for vaginal repair of enterocele and vaginal vault prolapse. Lower urinary tract, bowel, and sexual function may be maintained or improved. LEVEL OF EVIDENCE: II-3

ORIGINAL RESEARCH—BASIC SCIENCE: A Prospective Study Examining the Anatomic Distribution of Nerve Density in the Human Vagina

INTRODUCTION Women possess sufficient vaginal innervation such that tactile stimulation of the vagina can lead to orgasm. However, there are few anatomic studies that have characterized the distribution of nerves throughout the human vagina. AIM The aim of this prospective study was to better characterize the anatomic distribution of nerves in the adult human vagina. A secondary aim was to assess whether vaginal innervation correlates with the subjects demographic information and sexual function. METHODS Full-thickness biopsies of anterior and posterior vagina (proximal and distal), cuff, and cervix were taken during surgery in a standardized manner. Specimens were prepared with hematoxylin and eosin, and S100 protein immunoperoxidase. The total number of nerves in each specimen was quantified. Enrolled patients completed a validated sexual function questionnaire (Female Sexual Function Index, FSFI) preoperatively. MAIN OUTCOME MEASURES A description of vaginal innervation by location and an assessment of vaginal innervation in association with the subjects demographic information and sexual function. RESULTS Twenty-one patients completed this study, yielding 110 biopsy specimens. Vaginal innervation was somewhat regular, with no site consistently demonstrating the highest nerve density. Nerves were located throughout the vagina, including apex and cervix. No significant differences were noted in vaginal innervation based on various demographic factors, including age, vaginal maturation index, stage of prolapse, number of vaginal deliveries, or previous hysterectomy. There were no correlations between vaginal nerve quantity and FSFI domain and overall scores. Fifty-seven percent of the subjects had female sexual dysfunction; when compared to those without dysfunction, there were no significant differences in total or site-specific nerves. CONCLUSIONS In a prospective study, vaginal nerves were located regularly throughout the anterior and posterior vagina, proximally and distally, including apex and cervix. There was no vaginal location with increased nerve density. Vaginal innervation was not associated with demographic information or sexual function.

Practice patterns of physician members of the American Urogynecologic Society regarding female sexual dysfunction: results of a national survey

The purpose of the study was to evaluate practice patterns of members of the American Urogynecologic Society (AUGS) with respect to female sexual dysfunction (FSD). A brief self-administered survey of 20 questions was mailed to 966 physician members of the AUGS in the United States of America and Canada; 471 surveys were returned (49% response rate). The majority of responders see urogynecology (19%) or urogynecology and general gynecology patients (43%). Sixty-eight percent of physicians were familiar with questionnaires to assess FSD; however, only 13% said they use these for screening purposes. Most said they believed screening for FSD was somewhat (47%) or very important (42%). Despite having these beliefs, only 22% of the responding physicians stated they always screen for FSD, while 55% do so most of the time and 23% admitted they never or rarely screen. Similar results were obtained regarding screening following urogynecologic surgery. Several barriers to screening for FSD existed, the most common being lack of time. The majority of respondents (69%) underestimated the prevalence of FSD in their patient population. Finally, although more than half of responders had received post-residency training in urogynecology (59%), 50% of them stated the training with respect to FSD was unsatisfactory, while only 10% were satisfied. Overall, many urogynecologists do not consistently screen for FSD, underestimate its prevalence, and feel they received unsatisfactory training.

Female Sexual Dysfunction: Principles of Diagnosis and Therapy

Female sexual dysfunction is a common health problem, affecting approximately 43% of women. Female sexual dysfunction is defined as disorders of libido, arousal, orgasm, and sexual pain that lead to personal distress or interpersonal difficulties. It is frequently multifactorial in etiology, with physiological and psychologic roots. Approaching female sexual dysfunction involves an open discussion with the patient, followed by a thorough physical examination and laboratory testing. Therapy consists of patient and partner education, behavior modification, and may include individualized pharmacotherapy. Ultimately, as awareness and research in the field grows, it is hoped that a better understanding of the physiology and pharmacology of the female sexual response will be achieved. Target Audience: Obstetricians & Gynecologists, Family Physicians Learning Objectives: After completion of this article, the reader should be able to list the classifications of female sexual dysfunction, to outline the evaluation of a woman with female sexual dysfunction, and to summarize the various therapies for female sexual dysfunction.

Effects of an educational workshop on performance of fourth-degree perineal laceration repair.

OBJECTIVE: To develop a valid and reliable tool to objectively measure surgical skill necessary for repair of fourth-degree perineal lacerations and then to use this tool to measure improvement after a workshop. METHODS: We measured baseline surgical ability and clinical knowledge of 26 residents (postgraduate year [PGY]-1 to PGY-4) using the Objective Structured Assessment of Technical Skills (OSATS) and a written examination. The OSATS consists of a global surgical skills assessment (OSATS-G), a procedure checklist (OSAT-C), and pass/fail grade. Five weeks after our baseline evaluation, a 1.5-hour workshop was administered to approximately half of the 26 residents (n=14). One week after this intervention, the residents were re-examined using the same assessment tools. RESULTS: The OSATS demonstrated construct validity as scores on the examination increased on both the OSATS-G and the OSATS-C from PGY-1 through PGY-4 (P=.001 and P=.041, respectively). Reliability indices for the OSATS were high. Eighty-one percent of the residents failed the OSATS before intervention because of failure to identify and repair the internal anal sphincter. After educational intervention, senior residents improved on all assessments (OSATS-G, P=.041; OSATS-C, P=.004; written examination, P=.008), and all residents passed the OSATS. CONCLUSION: A valid and reliable OSATS and written examination were developed to assess surgical skills, knowledge, and judgment necessary to properly manage fourth-degree perineal lacerations. Residents improved on the OSATS and the written examination after undergoing a structured educational workshop. LEVEL OF EVIDENCE: II

Urethral erosion of a tension-free vaginal tape.

BACKGROUND Urethral dilation has been recommended to treat voiding dysfunction that may occur after placement of tension-free vaginal tape (TVT) for the treatment of stress urinary incontinence. We report on a case of urethral erosion by the tape secondary to repetitive urethral dilations after surgery. CASE A urethral erosion by the tape was diagnosed by cystoscopy after three urethral dilations failed to resolve postoperative voiding dysfunction 8 weeks after the initial procedure. A partial tape revision with repair of the urethrotomy was performed, with resolution of the subjects voiding dysfunction. CONCLUSION This report describes a potential complication of a recommended treatment for voiding dysfunction after placement of TVT.

The ability of history and a negative cough stress test to detect occult stress incontinence in patients undergoing surgical repair of advanced pelvic organ prolapse

To determine if a negative preoperative reduction cough stress test is a viable method of detecting occult stress incontinence or urge incontinence in women undergoing surgical repair of advanced pelvic organ prolapse. A retrospective chart review was done on all patients who denied any urinary complaints and had repair of advanced pelvic organ prolapse, grade two or greater, without the addition of an anti-incontinence procedure. Additionally patients had a simple office filling study done at the time of initial examination that failed to show the sign of stress incontinence or detrusor instability. Any urinary dysfunction that developed postoperatively was noted. A total of 53 patients met the inclusion criteria. Of these patients, one patient (1.9%) developed genuine stress incontinence, and one patient complained of urgency (1.9%). Patients without urinary complaints and a negative office filling study, who were present for surgical correction of advanced pelvic organ prolapse, have a low incidence of developing occult stress incontinence. Further work-up would not be cost effective.