Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent.

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). METHODS: This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. RESULTS: A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.

Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling System versus the Obtryx™ II Sling System.

PURPOSE: Limited data exist regarding sexual function after single incision sling (SIS) surgery. We compared sexual function 36 months postoperatively between patients undergoing SIS and transobturator sling (TMUS) for treatment of stress urinary incontinence. MATERIALS AND METHODS: Assessment of sexual function was a planned secondary objective of this prospective, multi-center study that enrolled women to Solyx SIS or Obtryx II TMUS. The primary study aim was to compare efficacy and safety using non-inferiority design at 36 months. Patient-reported outcomes of sexual function were assessed at baseline and 6, 12, 18, 24 and 36 months using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Changes in sexual function were analyzed within and between groups. Outcomes for patients requiring surgical retreatment were determined. RESULTS: Baseline characteristics were balanced using propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age, body mass index and concomitant surgery performed. Average length of followup was 30 months. Baseline sexual activity was similar (123/141 SIS, 114/140 TMUS, p=0.18). Severity of urinary incontinence did not correlate with baseline sexual activity. Mean PISQ-12 scores increased significantly from baseline to 36 months for both groups, indicating better sexual function at each visit. There were no significant differences in PISQ-12 scores between groups except at 36 months, where the difference was small (-2.5, 95% CI [-4.7, 0.2]). Among patients undergoing surgical retreatment (9/281, 3%), improvement in sexual function was maintained. De novo dyspareunia was rare following both treatments (SIS 1/141, TMUS 0/140, p=1.00). CONCLUSIONS: Patients have significant improvement in sexual function after SIS and TMUS. De novo sexual pain is low after sling surgery.

Prospective study of a single-incision sling versus a transobturator sling in women with stress urinary incontinence: 3-year results.

BACKGROUND: Long-term safety and efficacy data on use of single-incision slings in stress urinary incontinence are limited. OBJECTIVE: To determine whether the single-incision sling Solyx (Boston Scientific, Marlborough, MA) is noninferior to the transobturator sling Obtryx II (Boston Scientific) in efficacy and safety for treatment of stress urinary incontinence. This 522 post-market surveillance study has been designed in response to a Food and Drug Administration request to evaluate improvement in stress urinary incontinence at 36 months following single-incision sling compared with baseline, as well as provide an assessment of mesh-related complications and subject-reported outcomes, relative to the transobturator sling control. STUDY DESIGN: This prospective, nonrandomized, parallel cohort, multicenter postapproval study enrolled subjects to receive single-incision sling or transobturator sling. Study sites were assigned to a cohort group based on documented competency with the cohort device. Patient follow-up was 36 months to compare efficacy and adverse events for noninferiority. Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test, and post-void residual ≤150 cc. Participants were ineligible if they had undergone previous stress urinary incontinence surgery or had a previous mesh complication. Primary endpoint was treatment success defined by composite negative cough stress test and subjective improvement in stress urinary incontinence using Patient Global Impression of Improvement at 36 months. Secondary endpoints included adverse events and indications for retreatment. Noninferiority margins of 15% and 10% were prespecified for the primary efficacy and safety endpoints. Data analysis was performed using intent-to-treat and per-protocol methods. Due to the observational nature of the study, a propensity score methodology was applied to account for differences in patient and surgeon characteristics between treatment groups. The study design and variables to be included in the propensity score model were reviewed and approved by Food and Drug Administration reviewers before outcome analyses were performed. RESULTS: No evidence of imbalance in baseline characteristics was observed between groups after propensity score stratification in the 281 subjects. EBL (72.3±92 vs 73.1±63.9 mL, P=.786), time to spontaneous void (1.1±2 vs 0.8±2.8 days, P=.998), and time to discharge (0.7±0.7 vs 0.6±0.6 days, P=.524) were similar between groups. At 36 months, treatment success was 90.4% in the single-incision sling group and 88.9% in the transobturator sling group (P=.93). At 36 months, mesh-related complications were similar between groups (mesh exposure: 2.8% vs 5.0%, P=.38). Serious adverse events including pain during intercourse (0.7% vs 0%, P=1.00), pelvic pain (0.7% vs 0%, P=1.00), and urinary retention (2.8% vs 4.3%, P=.54) were similar between groups. CONCLUSION: Single-incision sling was not inferior to transobturator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events were acceptably low and similar between groups.

Preemptive Oral Compared With Intravenous Acetaminophen for Postoperative Pain After Robotic-Assisted Laparoscopic Hysterectomy: A Randomized Controlled Trial.

OBJECTIVE: To compare pain after robotic-assisted laparoscopic hysterectomy when giving preoperative oral compared with intravenous acetaminophen. METHODS: This double-blind randomized trial included women undergoing robotic-assisted laparoscopic hysterectomy for benign indications. Participants received either acetaminophen 1 g orally then normal saline 100 mL intravenously before surgery, or a placebo orally then acetaminophen 1 g intravenously. The primary outcome measured was difference in pain between the groups 2 hours postoperatively. A sample size of 74 participants (37/group) was needed to achieve 80% power to detect noninferiority using a one-sided, two-sample t-test with an alpha of 0.025 and a noninferiority margin of 10 mm. RESULTS: From April 2016 through August 2017, 77 patients were enrolled, with 75 participants included in the final analysis. Characteristics were similar between groups. No difference in average pain score was noted 2 hours after surgery, nor at any of the measured time points. Average scores for the oral and intravenous group, respectively, at 2 hours were 35 and 36 mm (P=.86), at 4 hours 36 and 37 mm (P=.96), and at 24 hours 35 and 36 mm (P=.79). Thirty-eight percent of participants in the oral group and 19% of participants in the intravenous group experienced nausea (P=.12). The oral group used 9.7 morphine equivalents in the recovery room, and the intravenous group used 9.5 morphine equivalents (P=.9). The oral group requested analgesia in 45 minutes on average, and the intravenous group requested analgesia in 43 minutes (P=.79). CONCLUSION: No difference in pain was observed 2 hours postoperatively when comparing preoperative administration of oral compared with intravenous acetaminophen. Given the ease of administration and lower cost of oral dosing, this study supports the oral route as part of the enhanced recovery after surgery protocol for minimally invasive gynecologic surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03391284.

Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis.

INTRODUCTION: It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency, frequency, and pain associated with interstitial cystitis (IC). This combination has also been reported to relieve pain associated with sex in patients with IC. AIM: The aim of this study was to corroborate these findings in a multicenter setting. METHODS: The study design was a multicenter prospective, double-blind, crossover, placebo-controlled trial. Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria (excluding cystoscopy) for IC. Each patient received drug and control, in random order, within 48 hours of enrolling in the study. MAIN OUTCOME MEASURES: The primary outcome measure was percent change in pain score (11-point analog pain scale) 12 hours after receiving the drug or control. Secondary measures were the global assessment response (GAR) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales. RESULTS: Eighteen (18) patients completed the trial. The average reduction of pain over 12 hours was 21% for control and 42% for active drug (P = 0.0363). GAR was 13% for control and 50% for drug (P = 0.0137). Average urgency reduction was 13% for control and 35% for drug (P = 0.0328). CONCLUSIONS: The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC. This combination provides significant immediate relief of symptoms for patients with IC.

Prevalence of interstitial cystitis in vulvodynia patients detected by bladder potassium sensitivity.

INTRODUCTION: Intravesical potassium sensitivity has been reported in 82% of vulvodynia patients, suggesting the bladder generates their pain and indicating interstitial cystitis (IC)/painful bladder syndrome deserves greater attention in differential diagnosis of vulvodynia. AIMS: The aims of this study were to: (i) determine the prevalence of IC as detected by intravesical potassium sensitivity; and (ii) survey for urinary, pelvic pain, and sexually associated symptoms in patients with vulvodynia. METHODS: Consecutive patients with vulvodynia were surveyed for urinary and pelvic pain symptoms using the pelvic pain and urgency/frequency (PUF) questionnaire, and tested for abnormal epithelial permeability using the potassium sensitivity test (PST). Rates of positive PST were determined overall and by PUF score range, and were compared in patients with intermittent vs. constant vulvodynia symptoms. MAIN OUTCOME MEASURES: Results of intravesical PST. RESULTS: Of 122 vulvodynia patients, 102 (84%) had a positive PST and 97 (80%) had urologic symptoms. Of the 87 sexually active patients, 81 (93%) reported pain associated with sex. Patients with constant (72/87, 83%) vs. intermittent symptoms (30/35, 86%) had no significant difference in rates of positive PST. Mean PUF score was 13.2. PUF scores of 3-4 were associated with an 86% rate of positive PST; scores 5-9, 44%; 10-14, 84%; 15-19, 87%; 20-24, 86%; and 25 and above, 100%. CONCLUSION: Most patients with vulvodynia have a positive PST and urgency/frequency, indicating pain of bladder origin (IC). IC deserves far greater consideration in the differential diagnosis of patients with vulvodynia. This represents a dramatic change for the gynecologic paradigm of vulvodynia, which in many cases appears to be referred pain from the urinary bladder.

Management of patients with interstitial cystitis or chronic pelvic pain of bladder origin: a consensus report.

BACKGROUND: Interstitial cystitis (IC) remains a challenging disease to treat, but increased awareness, better diagnostic tools, and effective pharmacologic agents can help non-urologists successfully manage this condition. Interstitial cystitis is much more prevalent than previously thought and is often misdiagnosed. Left untreated, IC can have a deleterious effect on the quality of life of the affected individual. In-office symptom-based techniques have been developed to screen for the presence of IC in both women and men presenting with symptoms of chronic pelvic pain (CPP) or chronic prostatitis (CP), and effective pharmacologic treatments exist that can provide acute and long-term symptom relief. Individual patient response to therapy varies, with some patients taking up to several months to achieve an optimal therapeutic response. To optimize patient response, a comprehensive algorithm for the diagnosis and management of IC should be utilized. Symptoms and progress should be assessed at each follow-up visit and changes in therapy made accordingly. Patients should be encouraged to learn as much as possible about IC and to take charge of the management of symptoms using their physician for guidance in decision making. The importance of this aspect of therapy should be reinforced at each subsequent visit. The entire office staff also has an important role in understanding and acknowledging each patient's pain and frustration as well as in providing support and education about IC. SCOPE: This paper presents recommendations from a multidisciplinary panel for the evaluation, diagnosis, treatment, and follow-up care of patients with IC or CPP of bladder origin.

The prevalence of interstitial cystitis in gynecologic patients with pelvic pain, as detected by intravesical potassium sensitivity.

OBJECTIVE: The purpose of this study was to determine the prevalence of interstitial cystitis in a large number of gynecologic patients with pelvic pain versus control subjects, as indicated by a positive result on a potassium sensitivity test. STUDY DESIGN: Gynecologists at four US medical centers administered the potassium sensitivity test to consecutive unselected patients with pelvic pain and control subjects. Before testing, each patient with pelvic pain was given an initial clinical diagnosis on the basis of the chief symptomatic complaint(s) and was surveyed for urologic symptoms. RESULTS: Of 244 patients with pelvic pain, 197 patients (81 %) had a positive result from a potassium sensitivity test. Positive potassium sensitivity test rates were comparable across all four sites and all clinical diagnoses that included endometriosis, vulvodynia (vulvar vestibulitis), and pelvic pain. Urologic symptoms were reported by 84% of patients, but only 1.6% of the patients had received an initial diagnosis of interstitial cystitis. None of the 47 control subjects were tested positive with the potassium sensitivity test. CONCLUSION: Interstitial cystitis may be a common unrecognized cause of pelvic pain in gynecologic patients and deserves greater, if not primary, consideration in the differential diagnosis of pelvic pain.

Increased prevalence of interstitial cystitis: previously unrecognized urologic and gynecologic cases identified using a new symptom questionnaire and intravesical potassium sensitivity.

OBJECTIVES: Most individuals with interstitial cystitis (IC) have both pelvic pain and urinary urgency/frequency, and many have dyspareunia. Existing questionnaires designed to assess bladder-origin pelvic pain (IC) give little attention to pelvic pain or dyspareunia, however. On the basis of our clinical experience with more than 5000 patients with IC, we have designed a pelvic pain and urgency/frequency (PUF) symptom scale that gives balanced attention to urinary urgency/frequency, pelvic pain, and symptoms associated with sexual intercourse. METHODS: We used the intravesical potassium sensitivity test (PST) to validate the PUF scale in urologic patients suspected of having IC, gynecologic patients with pelvic pain, controls, and women attending lectures given by one of us (C.L.P.). Positive potassium sensitivity is known to be associated with a bladder epithelial dysfunction present in most individuals with IC. RESULTS: The PST was positive in 74% of patients with a PUF score of 10 to 14, 76% of those scoring 15 to 19, and 91% of those scoring 20 or higher. All controls' PUF scores were less than 3, and the rate of positive PST in controls was 0%. The PUF scores in women screened at lectures suggested that 1 in 4.5 women have IC. CONCLUSIONS: High PUF scores appear to correlate directly with a higher likelihood of positive PST in both urologic patients suspected of having IC and gynecologic patients with pelvic pain. The PUF appears to be a valid tool for detecting IC in these two populations, as well as in the general population. Use of the PUF alone may prove to be an accurate method for detecting IC. The IC prevalence may be as high as 1 in 4.5 women.