Mickey M. Karram

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.

Transvaginal repair of vault prolapse: A review

Objective To provide a critical assessment of the published literature on transvaginal reconstructive techniques used to suspend a prolapsed vaginal vault. Data Source A Medline data base search and a bibliographic review of the relevant articles were conducted to identify all English-language articles on repair of vaginal vault prolapse. Methods of Study Selection Our literature search identified 34 articles published in peer-review journals and one article reported in another format, describing five different techniques. Tabulation, Integration and Results The size of each study population, modifications of the original surgical technique, complications, and results were tabulated and summarized for each surgical approach. Only sacrospinous ligament vaginal vault suspension and endopelvic fascia vaginal vault fixation had a sufficient number of cases to allow an informative evaluation of their effectiveness in managing vaginal vault prolapse. Of the 1229 patients who had undergone sacrospinous ligament suspension, 1062 were available for varying periods of follow-up; 193 (18%) of these developed recurrent pelvic relaxation—including 32 vaginal vault eversions, 81 anterior vaginal wall defects, 24 posterior vaginal wall prolapses, and 56 support defects at unspecified or multiple sites. Of the 367 patients who had undergone endopelvic fascia vaginal vault fixation, 322 were available for follow-up ranging from 1 to 12 years; 34 (11%) of these patients developed recurrent pelvic relaxation including nine vaginal vault prolapses, two anterior vaginal wall defects, 11 posterior vaginal wall relaxations, and 12 support defects at unspecified or multiple sites. Conclusion Published experience suggests that sacrospinous ligament suspension and endopelvic fascia fixation are effective in managing vaginal vault prolapse. Because of study limitations—including an absence of standardized outcome evaluation, relatively short follow-up periods, a substantial number of patients lost to follow-up, concomitant surgical procedures, and failure to assess visceral and sexual functions–the true efficacy of these two procedures remains inconclusive.

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

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.

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

The anatomic and functional outcomes of defect-specific rectocele repairs

OBJECTIVE This study was undertaken to evaluate the anatomic, functional, and quality-of-life effects of site-specific posterior colporrhaphy in the surgical management of rectocele. STUDY DESIGN In a retrospective observational study 125 patients were studied who had undergone site-specific posterior colporrhaphy between 1995 and 1996, either alone or in conjunction with other pelvic procedures. Physical examination was performed >/=6 months after the operation to assess the anatomic success of the repair. Standardized questionnaires were used to assess quality of life, sexual function, and bowel function. RESULTS Surgical correction was found at follow-up examination to have been achieved in 82% of eligible patients (73/89). All daily aspects of living improved significantly (P <.05), including ability to do housework (56% improvement or cure), travel (58% improvement or cure), and social activities (60% improvement or cure). Emotional well-being also significantly improved after the operation, as measured by thoughts of embarrassment (57% improvement or cure) or frustration (71% improvement or cure). Sexual function was not affected; however, reports of dyspareunia significantly (P <.04) improved or were cured after the operation in 73% of patients (19/26), worsened in 19% of patients (5/26), and arose de novo in 3 patients. Results showed no other significant differences in vaginal dryness, orgasm ability, sexual desire, sexual frequency, or sexual satisfaction. Bowel symptoms were assessed subjectively and were noted to have significantly improved (P <.008) after the operation. The following improvement or cure rates were obtained: stooling difficulties, 55%; pelvic pain or pressure, 73%; vaginal mass, 74%; and splinting, 65%. CONCLUSION This study indicates that defect-specific posterior colporrhaphy is equal to or superior to traditional posterior colporrhaphy. This type of repair provides durable anatomic support and is successful in restoring bowel function. It does not detrimentally affect sexual function, may aid in the resumption of sexual activity, and significantly improves quality of life and social aspects of daily living.

Mesh erosion after abdominal sacrocolpopexy

Objective To report our experience with erosion of perma-nent suture or mesh material after abdominal sacrocol-popexy. Methods A retrospective chart review was performed to identify patients who underwent sacrocolpopexy by the same surgeon over 8 years. Demographic data, operative notes, hospital records, and office charts were reviewed after sacrocolpopexy. Patients with erosion of either suture or mesh were treated initially with conservative therapy fol-lowed by surgical intervention as required. Results Fifty-seven patients underwent sacrocolpopexy using synthetic mesh during the study period. The mean (range) postoperative follow-up was 19.9 (1.3–50) months. Seven patients (12%) had erosions after abdominal sacrocol-popexy with two suture erosions and five mesh erosions. Patients with suture erosion were asymptomatic compared with patients with mesh erosion, who presented with vagi-nal bleeding or discharge. The mean (6 66 standard deviation) time to erosion was 14.0 6 66 7.7 (range 4–24) months. Both patients with suture erosion were treated conservatively with estrogen cream. All five patients with mesh erosion required transvaginal removal of the mesh. Conclusion Mesh erosion can follow abdominal sacrocol-popexy over a long time, and usually presents as vaginal bleeding or discharge. Although patients with suture ero-sion can be managed successfully with conservative treat-ment, patients with mesh erosion require surgical interven-tion. Transvaginal removal of the mesh with vaginal advancement appears to be an effective treatment in patients failing conservative management.

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.

Laparoscopic Burch colposuspension versus tension-free vaginal tape: A randomized trial

OBJECTIVE: To compare the laparoscopic Burch colposuspension with the tension-free vaginal tape procedure (TVT) for efficacy. METHODS: Seventy-two women from 2 institutions were randomized: 36 to laparoscopic Burch colposuspension and 36 to TVT. Multichannel urodynamic tests were performed preoperatively and 1 year after surgery. A research nurse administered the Urogenital Distress Inventory, Incontinence Impact Questionnaire, and pelvic examinations using the pelvic organ prolapse quantification system preoperatively, and at 6 months, 1 year, and 2 years after surgery. Voiding diaries were collected at 1 and 2 years. Primary outcome was objective cure, which was defined as no evidence of urinary leakage during postoperative urodynamic studies. Secondary outcomes included subjective continence, perioperative and postoperative data, and quality of life. RESULTS: Thirty-three laparoscopic Burch colposuspension and 33 TVT patients were analyzed with a mean follow-up of 20.6 ± 8 months (range 12–43). Mean operative time was significantly greater in the laparoscopic Burch colposuspension group compared with the TVT group, 132 versus 79 minutes, respectively (P = .003). Multichannel urodynamic studies in 32 laparoscopic Burch colposuspension and 31 TVT patients showed a higher rate of urodynamic stress incontinence at 1 year in the laparoscopic Burch colposuspension group, 18.8% versus 3.2% (P = .056). There was a significant improvement in the number of incontinent episodes per week and in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores in both groups at 1 and 2 years after surgery (P < .001). However, postoperative subjective symptoms of incontinence (stress, urge, and any urinary incontinence) were reported significantly more often in the laparoscopic Burch colposuspension group than in the TVT group (P < .04 for each category). CONCLUSION: The TVT procedure results in greater objective and subjective cure rates for urodynamic stress incontinence than does laparoscopic Burch colposuspension. LEVEL OF EVIDENCE: I

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

Incidence of recurrent cystocele after anterior colporrhaphy with and without concomitant transvaginal needle suspension

OBJECTIVE Our purpose was to compare the recurrent cystocele rate after anterior colporrhaphy versus anterior colporrhaphy performed in conjunction with transvaginal needle bladder neck suspension. STUDY DESIGN A retrospective chart review of all patients undergoing anterior colporrhaphy with and without needle bladder neck suspension over a 3-year period was conducted. Preoperatively all patients had symptomatic anterior vaginal wall relaxation. Patients undergoing concomitant needle suspension procedures had genuine stress incontinence. Twenty-seven patients underwent anterior colporrhaphy alone, and 40 patients underwent anterior colporrhaphy with needle suspension. Demographic data including age, parity, menopausal status, and use of estrogen replacement was collected for each group. The recurrence rate of anterior vaginal wall relaxation was determined for each group by reviewing standardized postoperative office notes. RESULTS There was no significant difference in the duration of follow-up between the two groups (13.2 months in the anterior repair group vs 13 months in the anterior repair-needle suspension group). However, a significant difference in recurrent cystocele rates was found between the two groups (7% [2/ 27] in the anterior repair group compared with 33% [13/40] in the anterior repair-needle suspension group, p < 0.01). CONCLUSION The incidence of recurrent cystocele is significantly higher after anterior colporrhaphy with concomitant needle bladder neck suspension compared with anterior colporrhaphy alone. This difference may be related to the vaginal retropubic dissection at the time of transvaginal needle bladder neck suspension resulting in an iatrogenic paravaginal defect or denervation of the anterior vaginal wall.