Bladder instillations versus onabotulinumtoxinA injection for interstitial cystitis/bladder pain syndrome: A randomized clinical trial.

BACKGROUND: Interstitial cystitis/bladder pain syndrome is an unpleasant sensation related to the bladder with lower urinary tract symptoms lasting more than six weeks, unrelated to an otherwise identifiable cause. The etiology is likely multifactorial including urothelial abnormalities, neurogenic pain upregulation, and potentially bladder and vaginal microbiome alterations. Despite treatment effectiveness of both bladder instillations and intradetrusor onabotulinumtoxinA injection for this condition, a head-to-head comparison has not been performed. OBJECTIVES: To compare the efficacy of bladder instillations and intradetrusor onabotulinumtoxinA injection for treatment of interstitial cystitis/bladder pain syndrome. STUDY DESIGN: Patients with O'Leary-Sant (OLS) questionnaire scores of ≥ 6, meeting clinical criteria for interstitial cystitis/bladder pain syndrome, and desiring procedural management were randomized to bladder instillations or intradetrusor onabotulinumtoxinA injection. The primary outcome was the difference in OLS scores at 2 months post-treatment between groups. Secondary outcomes included evaluation of sexual function, physical/mental health status, pain, patient satisfaction, treatment perception, retreatment, and adverse event rates. RESULTS: 47 patients were analyzed with 22 randomized to bladder instillations and 25 to onabotulinumtoxinA injection. There were no differences in demographic and clinical characteristics between groups. From baseline to 2 months post-treatment, there was a decrease in OLS subscales in all patients (Interstitial Cystitis Symptom Index (ICSI) -6.3 (CI -8.54, -3.95), p<.0001; Interstitial Cystitis Problem Index (ICPI) -5.9 (CI -8.18, -3.57), p<.0001). At 2 months post-treatment, patients in the onabotulinumtoxinA group had significantly lower OLS scores compared to those in the bladder instillation group (ICSI 6.3 ± 4.5 [onabotulinumtoxinA] versus 9.6 ± 4.2 [instillation], p=.008; ICPI 5.9 ± 5.1 [onabotulinumtoxinA] versus 8.3 ± 4.0 [instillation], p=.048). The difference in OLS scores between groups did not persist at 6-9 months post-treatment. There were no statistically significant differences between baseline and post-treatment time points for the remaining questionnaires. Eight percent of patients who received onabotulinumtoxinA injection experienced urinary retention requiring self-catheterization. Patients who underwent onabotulinumtoxinA injection were significantly less likely to receive retreatment within 6-9 months compared to patients who received bladder instillations (relative risk 13.6; 95% CI, 1.92-96.6; P=.0002). There were no differences between groups regarding patient satisfaction, perception of treatment convenience, or willingness to undergo retreatment. CONCLUSIONS: Both onabotulinumtoxinA injection and bladder instillations are safe, effective treatments for patients with interstitial cystitis/bladder pain syndrome, with significant clinical improvement demonstrated at 2 months post-treatment. Our findings suggest that intradetrusor onabotulinumtoxinA injection is a more effective procedural treatment for this condition than bladder instillation therapy and associated with decreased rates of retreatment.

Reduced versus standard intradetrusor OnabotulinumtoxinA injections for treatment of overactive bladder.

BACKGROUND: Intradetrusor onabotulinumtoxinA injection is an effective advanced treatment for overactive bladder. While the effective dosages have been well studied, very little data exist on treatment efficacy using differing injection techniques. The objective of this study was to determine whether the efficacy of a reduced injection technique of 5 injection sites was noninferior to the standard technique of 20 injection sites of intradetrusor onabotulinumtoxinA for treatment of overactive bladder. METHODS: In this randomized noninferiority trial, men and women seeking treatment of overactive bladder with intradetrusor onabotulinumtoxinA injections were randomized to receive 100 units administered via either a reduced injection technique of 5 injection sites or a standard injection technique of 20 injection sites. Subjects completed a series of standardized questionnaires at baseline and at 4-12 weeks postprocedure to determine symptom severity and treatment efficacy. The primary outcome was treatment efficacy as determined by Overactive Bladder Questionnaire-Short Form with a noninferiority margin of 15 points. Secondary outcomes were incidence of urinary tract infection and urinary retention requiring catheterization. RESULTS: Data from 77 subjects were available for analysis with 39 in the control arm (20 injections) and 38 in the study arm (5 injections). There was a significant improvement in both arms from baseline to follow-up in Overactive Bladder Questionnaire-Short Form and International Consultation on Incontinence Questionnaire scores (p < 0.001). Overall treatment success was 68% with no statistically significant difference between arms. A significant difference between arms was found on the Overactive Bladder Questionnaire-Short Form quality of life survey favoring the control arm (confidence interval [CI]: 0.36-20.5, p = 0.04). However, there were no significant differences between arms in the remaining validated questionnaires. The study arm did not demonstrate noninferiority to the control arm. Subjects in the study arm were significantly more likely to express a willingness to undergo the procedure again (odds ratio = 3.8, 95% CI: 1.42-10.67, p = 0.004). Adverse events did not differ between arms. CONCLUSIONS: A reduced injection technique for administration of intradetrusor onabotulinumtoxinA demonstrates similar efficacy to the standard injection technique but did not demonstrate noninferiority. Subjects preferred the reduced injection technique over the standard technique. A reduced injection technique is a safe and effective alternative to the standard technique.

Effects of Preoperative Gabapentin on Clinical Outcomes After Outpatient Midurethral Sling Placement.

OBJECTIVES: This study aimed to evaluate transient urinary retention in women undergoing outpatient midurethral sling placement who received preoperative gabapentin (treated) versus those who did not (untreated). Secondary outcomes included unexpected admission rates, analgesic usage, time to discharge, and pain. METHODS: This was a retrospective cohort study including women who underwent outpatient midurethral sling placement from 2015 to 2019. Exclusion criteria included suprapubic catheter placement, planned overnight admission, abnormal preoperative postvoid residual volume, and prolonged postoperative catheterization. Logistic regression was performed to evaluate gabapentin usage and urinary retention after adjusting for patient characteristics. RESULTS: Three hundred two women met the inclusion criteria, with 19.5% experiencing urinary retention after midurethral sling placement. Women older than 65 years were more likely to have urinary retention than those aged 18-65 years (29.8% vs 17.6%, P = 0.054). Of treated participants, 26% had urinary retention versus 18% of untreated participants (P = 0.162). Adjusting for age, parity, pain, operative time, blood loss, sling type, analgesic, scopolamine patch, or hemostatic agent use, treated participants had 72% higher odds of urinary retention (adjusted odds ratio, 1.72; 95% confidence interval, 0.88-3.38; P = 0.113). There was no difference in unexpected admission, analgesic usage, time to discharge, or pain between groups. CONCLUSIONS: One of 5 women had urinary retention after outpatient midurethral sling placement. Although no statistically significant difference was found in urinary retention between groups, the odds of urinary retention in the treated group were increased. Because there was no difference in pain, analgesic usage, or time to discharge between groups, investigation regarding gabapentin use for outpatient urogynecologic surgery is needed.

Preoperative pudendal block with liposomal and plain bupivacaine reduces pain associated with posterior colporrhaphy: a double-blinded, randomized controlled trial.

BACKGROUND: Pelvic reconstructive surgery may cause significant postoperative pain, especially with posterior colporrhaphy, contributing to a longer hospital stay and increased pain medication utilization. Regional blocks are being increasingly utilized in gynecologic surgery to improve postoperative pain and decrease opioid usage, yet preoperative pudendal blocks have not been used routinely during posterior colporrhaphy. OBJECTIVE: This study aimed to compare the effect of preoperative regional pudendal nerve block using a combination of 1.3% liposomal and 0.25% plain bupivacaine vs 0.25% plain bupivacaine alone on vaginal pain after posterior colporrhaphy on postoperative days 1, 2, and 3. We hypothesized that there would be a reduction in vaginal pain scores for the study group vs the control group over the first 72 hours. STUDY DESIGN: This was a double-blinded, randomized controlled trial that included patients undergoing a posterior colporrhaphy, either independently or in conjunction with other vaginal or abdominal reconstructive procedures. Patients were block randomized to receive 20 mL of either a combination of 1.3% liposomal and 0.25% plain bupivacaine (study) or 20 mL of 0.25% plain bupivacaine (control) in a regional pudendal block before the start of surgery. Double blinding was achieved by covering four 5-mL syringes containing the randomized local anesthetic. After induction of anesthesia, a pudendal nerve block was performed per standard technique (5 mL superiorly and 5 mL inferiorly each ischial spine) using a pudendal kit. The primary outcome was to evaluate postoperative vaginal pain using a visual analog scale on postoperative days 1, 2, and 3. Secondary outcomes included total analgesic medication usage through postoperative day 3, postoperative voiding and defecatory dysfunction, and impact of vaginal pain on quality of life factors. RESULTS: A total of 120 patients were enrolled (60 in each group). There were no significant differences in demographic data, including baseline vaginal pain (P=.88). Postoperative vaginal pain scores were significantly lower in the combined liposomal and bupivacaine group at all time points vs the plain bupivacaine group. Median pain scores for the study and control groups, respectively, were 0 (0-2) and 2 (0-4) for postoperative day 1 (P=.03), 2 (1-4) and 3 (2-5) for postoperative day 2 (P=.05), and 2 (1-4) and 3 (2-5) for postoperative day 3 (P=.02). Vaginal pain scores increased from postoperative day 1 to postoperative days 2 and 3 in both groups. There was a significant decrease in ibuprofen (P=.01) and acetaminophen (P=.03) usage in the study group; however, there was no difference between groups in total opioid consumption through postoperative day 3 (P=.82). There was no difference in successful voiding trials (study 72%, control 82%, P=.30), return of bowel function (P>.99), or quality of life factors (sleep, stress, mood, and activity). CONCLUSION: Preoperative regional pudendal block with a combination of liposomal and plain bupivacaine provided more effective vaginal pain control than plain bupivacaine alone for reconstructive surgery that included posterior colporrhaphy. Given the statistically significant decrease in vaginal pain in the study group, this block may be considered as a potential adjunct for multimodal pain reduction in this patient population.

A posterior uteroperitoneal fistula: an unexpected finding.

OBJECTIVE: To demonstrate a unique presentation and surgical treatment of a posterior uteroperitoneal fistula with excision of the fistula tract and repair in multiple layers. DESIGN: Illustrative video presentation. A case report is used to describe potential causes of an uteroperitoneal fistula found in a patient during evaluation of secondary infertility and to highlight surgical technique and management using the principles of fistula repair through a minimally invasive approach. The Institutional Review Board reviewed this video article and it was deemed "not human subject research." SETTING: Tertiary medical center. PATIENT(S): A 33-year-old G1P1001 woman with a history of a cesarean section presented with secondary infertility, pelvic pain, and dysmenorrhea and was found to have a posterior uteroperitoneal fistula at the time of hysterosalpingography. INTERVENTION(S): The patient underwent an uncomplicated robot-assisted laparoscopic excision of a posterior uteroperitoneal fistula with the use of careful dissection of the fistula tract, continuous reassessment, and tension-free closure in layers. MAIN OUTCOME MEASURE(S): Preoperative diagnosis and surgical management displaying intraoperative techniques for robot-assisted excision of fistula tract and repair of defect. RESULT(S): The patient underwent robot-assisted operative laparoscopy that revealed a 4-cm mass on the right posterior aspect of the uterus independent from her adnexa. Concomitant hysteroscopy revealed normal endometrium without an evident fistula. During chromopertubation, extravasation was seen into the peritoneal cavity from this mass. The mass and fistula tract were excised without a connection found from her cesarean scar, and reconstruction was performed in multiple layers. Endometriotic lesions were noted intraperitoneally in locations distant from the mass. The patient had significant improvement in her symptoms after surgery. CONCLUSION(S): We present a unique case of a suspected spontaneous posterior uteroperitoneal fistula in the presence of endometriosis without evidence of a connection to her prior hysterotomy scar. Possible etiologies include an undiagnosed, unrepaired hysterotomy extension or a result of chronic inflammation from deep infiltrating endometriosis. Adverse effects on fertility from uteroperitoneal fistulas may be due to disruption of sperm function or endometrial quality secondary to presence of old blood products sequestered in the fistula or due to resultant inflammation from the same. As in this video case, successful treatment of symptoms resulting from an uteroperitoneal fistula requires removal of the fistula tract. The constellation of pelvic pain, dysmenorrhea, postmenstrual bleeding, and infertility should raise suspicion for an uteroperitoneal fistula.

Clitoral Epidermal Inclusion Cyst Leading to Anorgasmia: A Case Report and Literature Review.

BACKGROUND: Clitoral epidermal inclusions cysts are most frequently seen following trauma, especially female genital mutilation. Spontaneous clitoral epidermal inclusion cysts are rare with an unclear etiology and their impact on later sexual function has not been described. CASE: A 15-year-old spontaneously developed a clitoral mass that progressively enlarged over seven years, ultimately leading to secondary anorgasmia. Surgical removal resulted in restoration of normal anatomy and complete return of clitoral function. Final pathology revealed the mass to be an epidermal inclusion cyst. SUMMARY AND CONCLUSION: Clitoral epidermal inclusion cysts typically present in childhood or early adolescence and can lead to sexual dysfunction if left untreated. Physicians must consider the potential sequelae of these cysts when counseling and managing these patients.