Outcomes following treatment for pelvic floor mesh complications.

INTRODUCTION AND HYPOTHESIS: Our aim was to determine symptoms and degree of improvement in a cohort of women who presented following treatment for vaginal mesh complications. METHODS: This study was a follow-up to a multicenter, retrospective study of women who presented to four tertiary referral centers for management of vaginal-mesh-related complications. Study participants completed a one-time follow-up survey regarding any additional treatment, current symptoms, and degree of improvement from initial presentation. RESULTS: Two hundred and sixty women received surveys; we had a response rate of 41.1 % (107/260). Complete data were available for 101 respondents. Survey respondents were more likely to be postmenopausal (p = 0.006), but otherwise did not differ from nonrespondents. Fifty-one percent (52/101) of women underwent surgery as the primary intervention for their mesh complication; 8 % (4/52) underwent a second surgery; 34 % (17/52) required a second nonsurgical intervention. Three patients required three or more surgeries. Of the 30 % (30/101) of respondents who reported pelvic pain prior to intervention, 63 % (19/30) reported improvement, 30 % (9/30) were worse, and 7 % (2/30) reported no change. Of the 33 % (33/101) who reported voiding dysfunction prior to intervention, 61 % (20/33) reported being at least somewhat bothered by these symptoms. CONCLUSIONS: About 50 % of women with mesh complications in this study underwent surgical management as treatment, and <10 % required a second surgery. Most patients with pain preintervention reported significant improvement after treatment; however, almost a third reported worsening pain or no change after surgical management. Less than half of patients with voiding dysfunction improved after intervention.

Randomised trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow up.

OBJECTIVE: To compare the long-term efficacy of laparoscopic Burch colposuspension with tension-free vaginal tape (TVT) for the treatment of urodynamic stress urinary incontinence (SUI). DESIGN: Long-term follow up from a prospective randomised trial. SETTING: Academic tertiary referral centre. SAMPLE: Seventy-two women with urodynamic SUI from two institutions. METHODS: Subjects were randomised to either laparoscopic Burch or TVT from August 1999 to August 2002. Follow-up evaluations occurred 6 months, 1 year, 2 years, and 4-8 years after surgery. MAIN OUTCOME MEASURES: Subjects completed the Incontinence Severity Index, Urogenital Distress Inventory 6 (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and Patient Global Impression of Improvement (PGI-I) scales. RESULTS: Median follow-up duration was 65 months (range 12-88 months) with 92% completing at least one follow-up visit. Seventy-four percent of subjects had long-term (4-8 years) follow up. Fifty-eight percent of subjects receiving laparoscopic Burch compared with 48% of TVT subjects reported any urinary incontinence 4-8 years after surgery (Relative Risk (RR):1.19; 95% CI: 0.71-2.0) with no significant difference between groups. Bothersome SUI symptoms were seen in 11 and 8%, respectively, 4-8 years after surgery (P = 0.26). There was significant improvement in the postoperative UDI-6 and IIQ-7 scores in both groups at 1-2 years that were maintained throughout follow up with no significant differences between the groups. CONCLUSIONS: TVT has similar long-term efficacy to laparoscopic Burch for the treatment of SUI. A substantial proportion of subjects have some degree of urinary incontinence 4-8 years after surgery; however, the majority of incontinence is not bothersome.

A randomized trial of local anesthesia with intravenous sedation vs general anesthesia for the vaginal correction of pelvic organ prolapse.

The purpose of this study is to compare the feasibility of local anesthesia with IV sedation versus general anesthesia for vaginal correction of pelvic organ prolapse. Patients with pelvic organ prolapse who were scheduled for an anterior or posterior colporrhaphy, or an obliterative procedure, and who did not have a contraindication or preference to type of anesthesia were randomized to one of the two anesthesia groups. Nineteen patients were randomized to the general group and 21 patients were randomized to the local group. Mean operating room, anesthesia, and surgical time were similar in each group, and 10 patients in the local group bypassed the recovery room. Requests and doses of antiemetics, postoperative verbal numerical pain scores and length of hospital stay were similar between the two groups. Mean recovery room and total hospital costs were significantly lower in the local group. Local anesthesia with IV sedation is a feasible alternative for vaginal surgery to correct pelvic organ prolapse.

Anatomy and physiology of the pelvic floor.

Lower urinary tract function consists of a complex interplay of neural input consisting of both involuntary and voluntary controls interacting with specialized anatomical structures. Damage to anatomical support structures may lead to derangements in urethral and bladder function. In addition, disorders related to physiological and neurological function of the lower urinary tract can result in abnormalities in the storage and evacuation of urine. The ultimate goal in the evaluation and management of women with pelvic floor dysfunction is to correlate functional derangements with anatomical changes. The understanding of various pelvic support defects in the pelvic visceral supports also allows the physician to perform the correct surgery needed for successful outcomes.

Anatomic and functional outcome of vaginal paravaginal repair in the correction of anterior vaginal wall prolapse.

Over a 2-year period 45 patients with bilateral paravaginal support defects underwent vaginal paravaginal repair. Postoperative evaluations were conducted and anatomic outcome was determined by vaginal examination, with grading of vaginal wall support. Functional outcome was assessed by a standardized quality of life questionnaire, voiding dairy and standing stress test with a full bladder. Thirty-five patients had long-term follow-up with a mean of 1.6 years (range 1-85). The recurrence rates for displacement cystocele, enterocele and rectocele were 3% (1/35), 20% (7/35) and 14% (5/35), respectively. In no patients did vault prolapse develop or recur. Subjective or objective evidence of persistent stress urinary incontinence was found in 57% of patients (12/21). Vaginal paravaginal repair is a safe and effective technique for the surgical correction of anterior vaginal wall prolapse but has limited applicability in the surgical correction of genuine stress incontinence.

Vaginal configuration on MRI after abdominal sacrocolpopexy and sacrospinous ligament suspension.

An MRI study was conducted to compare the vaginal configuration of women who had undergone sacrospinous fixation with transvaginal needle suspension or abdominal sacrocolpopexy with retropubic colposuspension with that of normal controls. MRI examination demonstrated that in normal controls the lower vagina formed an acute angle (mean 53 degrees) with the pubococcygeal line and intersected the upper vagina at a mean angle of 145 degrees. In the abdominal repair group the lower vagina intersected the pubococcygeal line at a mean angle of 57 degrees and joined the upper segment at a mean angle of 137 degrees. In the vaginal repair group the lower vagina intersected the pubococcygeal line at a mean angle of 54 degrees and joined the upper segment at a mean angle of 220 degrees. Our study demonstrated that abdominal sacrocolpopexy with retropubic colposuspension more closely restored the vagina to its normal configuration, whereas sacrospinous fixation with transvaginal needle suspension creates an abnormal vaginal axis.

Periurethral collagen injection for stress incontinence with and without urethral hypermobility.

OBJECTIVE: To compare the use of periurethral collagen injection in the treatment of female stress urinary incontinence due to intrinsic sphincter deficiency in women with and without urethral hypermobility. METHODS: A retrospective review was performed of 60 periurethral collagen injections performed on 40 consecutive women from January 1996 to December 1997. A review of the office chart and operative notes was performed to obtain demographic, urodynamic, and procedural data. Outcome data were obtained by personal or telephone interview, using patients' subjective assessments including an analog satisfaction scale. RESULTS: Nine of 40 patients (23%) had urethral hypermobility. Compared with patients without hypermobility, patients with hypermobility required a similar number of procedures (a mean of 1.9 compared with 1.4, P = .13) and required similar amounts of collagen on the first injection (5.6 mL compared with 5.3 mL, P = .69). Preoperative urodynamic parameters were similar in both groups. Rates of subjective dryness were equivalent in patients with and without hypermobility at 1 month (76% and 46%, P = .24) and at 6 months (71% and 32%, P = .09) following initial injection. A post hoc power analysis was performed to evaluate the primary study measures of continence at 1 and 6 months, and number of collagen injections. This revealed that a sample size of 40 patients would be sufficient to detect a 2.5-fold difference in number of injections and a 3-fold difference in subjective dryness. CONCLUSION: Coexisting urethral hypermobility should not preclude the use of collagen injections in women with stress urinary incontinence.

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.

A retrospective comparison of abdominal sacrocolpopexy with Burch colposuspension versus sacrospinous fixation with transvaginal needle suspension for the management of vaginal vault prolapse and coexisting stress incontinence.

The objective of this study was to compare the surgical outcome of abdominal sacrocolpopexy and Burch colposuspension with sacrospinous fixation and transvaginal needle suspension in the management of vaginal vault prolapse and coexisting stress incontinence. One hundred and seventeen women with vaginal vault prolapse and coexisting stress incontinence were surgically managed over a 7-year period. The first 61 consecutive women who underwent sacrospinous fixation and transvaginal needle suspension comprised the vaginal group, and the following 56 consecutive women who underwent abdominal sacrocolpopexy and Burch colposuspension comprised the abdominal group. Office records were reviewed to assess the presence of recurrent prolapse and urinary incontinence during postoperative follow-up. Objective follow-up was available for 101 women. Mean duration of follow-up was 24.0 +/- 15 months for the vaginal group, and 23.1 +/- 12.6 months for the abdominal group. The incidence of recurrent prolapse to or beyond the hymen (33% vs. 19%, P=0.0505) and lower urinary tract symptoms (26% vs. 13%, P = 0.0506) were significantly higher in the vaginal group than in the abdominal group. Our data suggest that the combined abdominal approach has a lower incidence of recurrent prolapse and lower urinary tract symptoms than the combined vaginal approach in managing vaginal vault prolapse and coexisting stress incontinence.

Computed tomography comparison of bony pelvis dimensions between women with and without genital prolapse.

OBJECTIVE: To compare bony pelvis dimensions between white women with and without genital prolapse using computed tomography (CT) pelvimetry. METHODS: Thirty-four multiparous white women with vaginal prolapse beyond the hymen and 34 matched white controls with no signs or symptoms of pelvic support defects underwent CT pelvimetry. The anteroposterior and transverse diameters of the pelvic inlet, the interspinous diameter of the midpelvis, and the intertuberous diameter of the pelvic outlet were measured. Post hoc power analysis showed that 22 women were needed in each group to detect a 10% difference in the pelvic dimensions between groups, with an alpha error of 1% and a beta error of 10%, resulting in a 90% power. RESULTS: Mean (+/- standard deviation [SD]) age of the subjects was 63.4+/-8.3 years, compared with 62.9+/-7.8 years for controls. Mean parity of the subjects was 3.3+/-1.7, compared with 3.6+/-1.7 for controls. Mean (+/- SD) anteroposterior (12.5+/-1.3 versus 12.8+/-1.0 cm), interspinous (11.5+/-0.8 versus 11.2+/-0.9 cm), and intertuberous (10.0+/-1.0 versus 9.8+/-0.8 cm) diameters were not significantly different between study groups. Mean transverse diameter of the pelvic inlet was significantly greater in women with prolapse than those without prolapse (12.9+/-0.7 versus 12.4+/-0.6 cm, P = .006). CONCLUSION: Women with advanced vaginal prolapse have larger transverse inlet diameters than do women with normal pelvic support.

Mesh erosion after abdominal sacrocolpopexy.

OBJECTIVE: To report our experience with erosion of permanent suture or mesh material after abdominal sacrocolpopexy. 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 followed 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 sacrocolpopexy with two suture erosions and five mesh erosions. Patients with suture erosion were asymptomatic compared with patients with mesh erosion, who presented with vaginal bleeding or discharge. The mean (+/-standard deviation) time to erosion was 14.0+/-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 sacrocolpopexy over a long time, and usually presents as vaginal bleeding or discharge. Although patients with suture erosion can be managed successfully with conservative treatment, patients with mesh erosion require surgical intervention. Transvaginal removal of the mesh with vaginal advancement appears to be an effective treatment in patients failing conservative management.

Pelvic floor electrical stimulation for genuine stress incontinence: who will benefit and when?

This study sought to determine the characteristics of women in whom pelvic floor electrical stimulation will reduce stress urinary incontinence. It also evaluates how long electrical stimulation should be used before significant improvements are seen in clinical outcomes. Subjects with genuine stress incontinence were enrolled into a multicenter non-randomized trial. They used electrical stimulation for 15 minutes twice daily or every other day for 20 weeks. At the end of 20 weeks, those with a 50% reduction in leakage episodes on voiding diary ('responders') were compared with those who did not show a 50% reduction ('non-responders'). Thirty-one subjects were enrolled and 28 completed the study. After the treatment period, 19 subjects were defined as responders and 9 as non-responders. There were no significant differences between the two groups in baseline demographics (e.g. age, parity, largest birth weight etc.) other than body mass index (greater in nonresponders). Significant subjective and objective improvements were noted among responders by 10 and 14 weeks, respectively. Compliance was higher in responders during weeks 12-15 of the study (P=0.05). It was concluded that a minimum of 14 weeks of pelvic floor stimulation was necessary before significant objective improvements were seen. Body mass index and patient compliance may affect success.

Comparative tolerability of drug therapies used to treat incontinence and enuresis.

Drug therapy for incontinence and enuresis has met with varying degrees of success. Currently, there is no medication available that specifically targets the lower urinary tract without having untoward effects elsewhere in the body. Patients with urge incontinence are the most difficult group to treat. The agents most commonly used to treat urge incontinence, i.e. anticholinergics, musculotropics and tricyclic antidepressants, are limited in their effectiveness and have anticholinergic adverse effects. Other medications with theoretical treatment potential such as nonsteroidal anti-inflammatory drugs and calcium antagonists require more in depth clinical study before widespread use is appropriate. Although estrogen is well tolerated, its role in the treatment of incontinence in postmenopausal women may be limited. Medical treatment for stress incontinence is most successful in patients with a mild condition. Drugs with alpha-adrenergic activity alone or in combination with estrogen in postmenopausal women, are fairly effective and demonstrate few adverse effects at doses used to treat stress incontinence. Enuresis pharmacotherapy consists mainly of desmopressin and tricyclic antidepressants. Adverse effects are minimal with the doses commonly used. While the majority of patients improve with therapy, a significant portion relapse after treatment is terminated. Tolerability of a particular therapy depends on the effectiveness and adverse effects of the agent, the severity of incontinence and the general health of the patient. In general, patients are willing to accept a greater degree of inconvenience if a drug produces the desired effect. However, individualisation of therapy should be used to maximise compliance and outcome. Blinded, dose-titration studies are needed to better determine doses for optimum tolerability. Research into drugs specifically targeting the lower urinary tract may lead to more effective and well tolerated therapy for incontinence and enuresis.

Factors affecting detrusor contraction strength during voiding in women.

OBJECTIVE: To compare voiding mechanisms in continent and stress incontinent women and to assess the effects of aging, childbirth, menopausal status, and anterior vaginal wall relaxation on detrusor contraction strength during voiding. METHODS: Thirty-eight asymptomatic female volunteers underwent a thorough evaluation including multichannel urodynamic testing and instrumented pressure-flow voiding studies. The voiding mechanisms and detrusor contraction strengths, available in 30 women, were compared with those of 70 women evaluated previously with objective evidence of genuine stress urinary incontinence. The effect of age, parity, bladder neck mobility, and anterior vaginal wall relaxation on maximum detrusor pressure was assessed using chi2 and linear regression analyses. Detrusor pressures in premenopausal and postmenopausal women and continent and stress incontinent women were also compared. RESULTS: Four types of voiding mechanisms were identified. All 30 of the continent women voided with a detrusor contraction, compared with 59 (84%) of genuine stress incontinent subjects. The mean +/- standard deviation [SD]) detrusor contraction was significantly stronger in continent women than incontinent women (20.3 +/- 14.2 cm H2O compared with 12.3 +/- 11.0 cm H2O; P < .01). In continent and incontinent subjects, maximum detrusor pressure did not correlate significantly with increasing age, parity, bladder neck mobility, or degree of anterior vaginal wall relaxation. Premenopausal women had significantly higher mean (+/- SD) maximum detrusor pressures than postmenopausal women (16.3 +/- 13.0 cm H2O compared with 11.5 +/- 11.0 cm H2O; P < .01). CONCLUSION: Women with genuine stress urinary incontinence may be more likely to void with a weak or absent detrusor contraction than continent women. Menopausal status was the only factor identified that significantly affected maximum detrusor pressure during voiding.