A randomized trial comparing vaginal laser therapy and pelvic floor physical therapy for treating women with stress urinary incontinence.

INTRODUCTION: Female stress urinary incontinence (SUI) is considered a major public health issue. Physical therapy is an important conservative treatment; however, it is primarily limited by poor long-term compliance. Furthermore, surgical treatment entails significant risks. Therefore, new treatment techniques must be identified. OBJECTIVE: To compare the use of laser therapy and pelvic floor (PF) physical therapy for treating postmenopausal women with SUI. METHODS: This pilot study enrolled 40 women with a clinical and urodynamic diagnosis of SUI who were randomized into two groups: those who received erbium-doped yttrium-aluminum-garnet (Er:YAG) laser therapy implemented over three sessions with a 1-month interval (n = 20) and those who received physical therapy with supervision twice a week for 3 months (n = 20). In total, 16 women completed the treatment in each group. The patients were assessed for PF function using the modified Oxford scale and for pelvic organ prolapse using the Pelvic Organ Prolapse Quantification System. The 1-h pad test and quality of life questionnaires, King's Health Questionnaire (KHQ), and Incontinence Quality of Life (IQOL) were also administered. Patients were re-evaluated at 1, 3, 6, and 12 months after treatment. RESULTS: The mean patient age was 62.7 ± 9.1 and 57.9 ± 6.1 years, median Oxford score at baseline was 3 (2-4.5) and 4 (3-4), mean IQOL score was 79.8 ± 17 and 74.6 ± 18 for physical therapy group (PTG) and laser group (LG), respectively. For the amount of urine leak in the 1-h pad test evaluation, we found significance for the interaction of group and time points only for the Laser intragroup. The cure rate, that is, the rate of reaching an insignificant score in the pad test, at 6 and 12 months was 43.75% and 50% in PTG and 62.5% and 56.25% in the LG, respectively (p > 0.05). IQOL scores demonstrated considerable improvement in both groups (p > 0.05). Upon comparing the initial and follow-up results, the LG showed an improvement at all consultations, whereas the PTG showed improvements at 1, 3, and 6 months but not at 12 months after treatment. KHQ analysis revealed a considerable improvement in the quality of life (QOL) of patients over time, with no substantial difference between the groups. QOL comparison before and after treatment revealed that the vaginal LG improved more consistently in some domains. Only the PTG showed a significant increase in the mean Oxford score from pretreatment to 1 and 3 months after treatment (p < 0.001 and p = 0.002, respectively). However, no statistically significant difference was observed between the groups. CONCLUSION: Both treatments are safe and have a positive influence on the impact of UI on patients' QOL. The laser caused a greater reduction in the urinary loss, as measured using the weight of pad test, at 6-month and 12-month after treatment without difference with PTG at the end of the follow-up.

Biologic grafts for cystocele repair: does concomitant midline fascial plication improve surgical outcomes?

INTRODUCTION AND HYPOTHESIS: This study aims to compare the efficacy of porcine graft-augmented anterior prolapse repair with and without underlying pubocervical fascia plication. METHODS: Women with symptomatic anterior prolapse who underwent transvaginal repair, using biologic graft via transobturator approach, were retrospectively studied. An initial cohort had the graft placed without fascial plication. A second cohort had graft placement as an overlay to fascial plication. RESULTS: Between March 2005 and September 2008, 65 subjects underwent anterior repair with biologic graft; 35 without fascial plication and 30 as an overlay to plication. At 6 months follow-up, anatomic recurrence (Ba>/= -1) was significantly higher in the non-plicated group (18/35, 51%) compared with the plicated group (2/30, 7%) p < 0.01. Five (5/35, 14%) in the non-plicated group compared with none (0/30) in the plicated group underwent further treatment (p = 0.06). CONCLUSIONS: When using a non-crosslinked biologic graft for repair of anterior vaginal prolapse, we recommend the addition of concomitant midline fascial plication to enhance anatomic outcome.

Are there predictors of outcome following rectovaginal fistula repair?

BACKGROUND: Rectovaginal fistula is a distressing condition for patients and for physicians who are continuously challenged in providing durable treatment options. The aim of this study is to assess the results of rectovaginal fistula repair and identify predictive factors for poor outcome. METHODS: Retrospective analysis of patients who underwent rectovaginal fistula repair from 1988 to 2008 was performed. chi tests and logistical regression analysis were used to study treatment outcomes according to the following fistula characteristics: etiology, size, location, and number of prior attempts at fistula repair. In addition, patient factors such as age, body mass index, smoking history, comorbid condition of diabetes, use of steroid and immunosuppressive medications, number of prior vaginal deliveries, and presence of a diverting stoma were analyzed. RESULTS: A total of 184 procedures were performed in 125 patients. Inflammatory bowel disease was the most common indication for surgery (45.6%), followed by obstetric injury (24%) and surgical trauma (16%). The mean duration of fistula presence was 31.2 months. The procedures performed included endorectal advancement flap (35.3%), gracilis muscle interposition (13.6%), seton placement (13.6%), and transperineal (8.7%) and transvaginal repair (8.1%). The overall success rate per procedure was 60%, with no difference in recurrence rates based on the type of repair. Patients with Crohn's disease had more recurrent fistulas (44.2% success per procedure; P < .01), although 78% eventually healed after an average of 1.8 procedures. Patients with obstetric injuries had an 89% success rate after an average of 1.3 procedures per patient, which is similar to the success rate for traumatic fistulas. Pouch vaginal fistulas had a 91% success rate after an average of 1.6 procedures per patient. The overall success rate per patient was 88% after multiple procedures with a mean follow-up of 16.3 months. Age, body mass index, diabetes, use of steroids and immunosuppressive agents, size and location of the fistula, number of vaginal deliveries, time interval between a recurrent episode and subsequent repair, and the presence of fecal diversion did not affect outcomes. The presence of Crohn's disease and a smoking history are strongly associated with rectovaginal fistula recurrence (P = .02). CONCLUSIONS: Despite a relatively low initial success rate (60%), most rectovaginal fistulas can be successfully repaired with subsequent operations. Crohn's disease and smoking are associated with adverse outcomes.

Validation of a global pelvic floor symptom bother questionnaire.

INTRODUCTION AND HYPOTHESIS: This study aimed to validate a symptom questionnaire to assess presence and patient bother as related to common pelvic floor disorders. METHODS: The validation of the Pelvic Floor Bother Questionnaire (PFBQ) included evaluation of internal reliability, test-retest reliability, and validity of the items. RESULTS: A total of 141 patients with mean age of 61.8 +/- 13.2 were included in the study. Twenty-four percent of patients complained of stress urinary incontinence, 14.9% mixed incontinence, 14.9% urge incontinence, 10% fecal incontinence, 5.7% obstructed defecation, 28.4% pelvic organ prolapse, and 2.1% dyspareunia. The PFBQ demonstrated good reliability (alpha = 0.61-0.74; ICC = 0.94). There was a strong agreement beyond chance observed for each question (k = 0.77-0.91). PFBQ correlated with stage of prolapse (rho = 0.73, p < 0.0001), number of urinary and fecal incontinence episodes (rho = 0.81, p < 0.0001; rho = 0.54, p < 0.0001), and obstructed defecation (rho = 0.55, p < 0.0001). CONCLUSION: The PFBQ is a useful tool that can be easily used for identification and severity or bother assessment of various pelvic floor symptoms.

"Eyeball" POP-Q examination: shortcut or valid assessment tool?

INTRODUCTION AND HYPOTHESIS: The objective of this study was to compare the results of the Pelvic Organ Prolapse Quantification (POP-Q) examination by visual estimation to measurement. METHODS: Women with pelvic organ prolapse underwent both "eyeball"/estimated and measured POP-Q examinations by two trained examiners in a randomized order. POP-Q points and stage were analyzed using the paired t test, chi-square, Pearson's correlation, and kappa statistics. RESULTS: Fifty subjects had a mean age of 60, mean BMI 27.8, and median parity of 2. The POP-Q stages by the measured technique were 18% (9/50) stage 1, 38% (19/50) stage 2, 44% (22/50) stage 3, and 0% (0/50) stage 4. The POP-Q stages based on estimation and measurement were highly associated (p < 0.05). Individual points did not differ significantly between the techniques and did not differ significantly between examiners (all p > 0.05). CONCLUSION: Among examiners who routinely perform POP-Q examinations, there is no significant difference between "eyeball"/estimated and measured POP-Q values and stage.

Primary versus recurrent prolapse surgery: differences in outcomes.

INTRODUCTION AND HYPOTHESIS: We set out to evaluate anatomical outcomes of recurrent vs. primary prolapse surgery, focusing on anterior colporrhaphy (AC). METHODS: A retrospective study was performed comparing patients who underwent AC for recurrent cystocele (group I) and a matched control group who underwent primary AC (group II). RESULTS: Thirty-one patients were included in each group. Median follow-up was 22 (5-55) months. Successful anterior vaginal support was obtained in 18/23 (78.2%) patients in group I and 17/21 (81%) patients in group II at 1 year (p = 1.000) and in 9/21 (42.8%) patients in group I and in 15/21 (71.4%) patients in group II at 2-year follow-up (p = 0.031). CONCLUSIONS: Recurrent cystocele repair has a higher anatomic failure rate than primary repair at 2-year follow-up. Alternative surgical techniques that provide better long-term durability may be beneficial in repair of recurrent anterior wall prolapse.

Defecographic pelvic floor abnormalities in constipated patients: does mode of delivery matter?

BACKGROUND: The aim of this study was to demonstrate the distribution of defecographic pelvic floor abnormalities in constipated female patients and to correlate these dysfunctions with the mode of delivery. METHODS: Two hundred and fifty-five female patients who underwent defecography for constipation from 2001 to 2008 were reviewed and pelvic floor abnormalities were assessed. The patients were divided into three groups: group I had 50 nulliparous women, mean age 40.2 (+ or - 15.3), group II had 165 vaginally parous women, mean age 57 (+ or - 13.3), and group III had 40 patients delivered by cesarean section, mean age 50.6 (+ or - 11.9). RESULTS: Significant rectocele was identified in group I (36%), group II (35.8%), and group III (20%) without any statistically significant differences among the groups (p > 0.05). Intussusception was identified in group I (48%), group II (70.3%), and in group III (67.5%; p = 0.014). Intussusception associated with significant rectocele was more common in vaginally parous patients (p = 0.043). Abnormalities on puborectalis relaxation associated or not associated with rectocele were similar among the groups (p = 0.47). Vaginally parous patients had more abnormal exams as compared to other patients (p = 0.005). Significant rectocele was identified in (39%) patients with age > or = 50 years and in (26.3%) patients with age <50 years (p = 0.03). CONCLUSION: There was no specific correlation between distribution of pelvic floor disorders and mode of delivery in this study. Patients of age greater than 50 years had a higher incidence of significant rectocele.

Anterior repair with or without collagen matrix reinforcement: a randomized controlled trial.

OBJECTIVE: To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft. METHODS: Women with anterior vaginal wall prolapse were enrolled in a randomized fashion in this grafted compared with nongrafted repair study. Outcome measures included pelvic organ prolapse quantification data, quality-of-life assessment, healing abnormalities, and complications. RESULTS: Ninety-four patients were enrolled. Seventy-two (77%) provided 1-year data, and 59 (63%) supplied 2-year data. Demographics and stage of prolapse were similar between groups at baseline. Postoperative complications consisted basically of low urinary tract infection and were low in both groups (10 in bovine pericardium graft and 16 in anterior colporrhaphy alone). One year after surgery, successful anterior vaginal wall support was obtained in 85.7% of the bovine pericardium graft group and 78.4% of anterior colporrhaphy-alone group (P=.544). For the cohort that comprised 2-year analyses, the success rate was 76.5% for the bovine pericardium graft group and 63% for anterior colporrhaphy-alone group (P=.509). Postoperative Urogenital Distress Inventory-6 and Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire-12 scores were uniformly improved over baseline in both groups. CONCLUSION: The use of bovine pericardium graft for anterior vaginal prolapse does not have higher complication rates or healing difficulties. At 1- and 2-year follow-up, anterior colporrhaphy with bovine pericardium reinforcement did not show a statistically significant improvement over colporrhaphy alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00860912 LEVEL OF EVIDENCE: I.