Purpose

Overactive bladder (OAB) syndrome significantly impairs quality of life, often necessitating pharmacological interventions with associated risks. The fragility of OAB trial outcomes, as measured by the fragility index (FI: smallest number of event changes to reverse statistical significance) and quotient (FQ: FI divided by total sample size expressed as a percentage), is critical yet unstudied.

Materials and methods

We conducted a systematic search for randomized controlled trials on OAB medications published between January 2000 and August 2023. Inclusion criteria were trials with two parallel arms reporting binary outcomes related to OAB medications. We extracted trial details, outcomes, and statistical tests employed. We calculated FI and FQ, analyzing associations with trial characteristics through linear regression.

Results

We included 57 trials with a median sample size of 211 participants and a 12% median lost to follow-up. Most studies investigated anticholinergics (37/57, 65%). The median FI/FQ was 5/3.5%. Larger trials were less fragile (median FI 8; FQ 1.0%) compared to medium (FI: 4; FQ 2.5%) and small trials (FI: 4; FQ 8.3%). Double-blinded studies exhibited higher FQs (median 2.9%) than unblinded trials (6.7%). Primary and secondary outcomes had higher FIs (median 5 and 6, respectively) than adverse events (FI: 4). Each increase in 10 participants was associated with a +0.19 increase in FI (p < 0.001).

Conclusions

A change in outcome for a median of five participants, or 3.5% of the total sample size, could reverse the direction of statistical significance in OAB trials. Studies with larger sample sizes and efficacy outcomes from blinded trials were less fragile.

This cross-sectional study investigates injury trends associated with electric bicycles in the US from 2017 to 2022.

Purpose

We evaluate the efficacy and safety profiles of currently available conservative management options for penile and urethral lichen sclerosus.

Materials and methods

A systematic review of existing literature on lichen sclerosus was conducted utilizing the PubMed, Embase, and Web of Science databases. References were assessed for relevance to nonsurgical management of male genital lichen sclerosus by title and abstract by 3 independent reviewers, then reviewed in full and in duplicate by 5 independent reviewers.

Results

Seventeen studies describing conservative management of histologically confirmed penile and urethral lichen sclerosus in male patients were included in the final review. We present available evidence supporting the use of 4 major treatment modalities represented in the existing literature: topical corticosteroids, tacrolimus, platelet-rich plasma, and CO₂ laser. We also briefly discuss the limited studies on the use of oral acitretin and polydeoxyribonucleotide injections. Outcomes assessed include symptoms, clinical appearance, quality of life, sexual satisfaction, adverse effects, and long-term efficacy of treatment.

Conclusions

Topical corticosteroids remain the mainstay of conservative management of penile and urethral lichen sclerosus, with current literature supporting the use of other therapies such as tacrolimus and platelet-rich plasma as alternatives or adjuvant treatments when escalation of treatment is necessary. Future research should further explore the efficacy and safety of newer therapies through additional controlled clinical trials in the targeted population.

Objective

To characterize adverse events related to use of the perirectal spacing agent SpaceOAR, we examined the Manufacturer and User Facility Device Experience (MAUDE) database.

Methods

The MAUDE database was queried for "SpaceOAR" and "Augmenix" from June 2015 (when SpaceOAR was approved by the Food and Drug Administration) to October 2022. Reports were reviewed for adverse events (AEs), operative procedures performed because of the AE, and changes to the radiation plan. AEs were categorized using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Results

Six hundred fifty-four reports were reviewed. Eighty-four were excluded and 4 reports reviewed 2 separate cases of SpaceOAR administration. Five hundred seventy-four cases were ultimately included. Three deaths were reported (0.5% of all AEs). One point six percent of cases represented CTCAE grade 4 injuries (life-threatening consequences; urgent intervention indicated), 15.9% grade 3 (severe but not immediately life-threatening; hospitalization), 24.2% grade 2 (moderate; local/noninvasive intervention), and 57% of events were CTCAE grade 1 (mild; asymptomatic or mild symptoms). Bowel diversion occurred in 29 cases (9%).

Conclusion

Both asymptomatic (n = 311) and debilitating (n = 12) complications of SpaceOAR hydrogel use were identified. Death, gel embolization, anaphylaxis, rectal ulcerations, and infections requiring bowel or urinary diversions were among the complications reviewed. Providers should consider these potential complications before perirectal spacer administration and during patient counseling.

Objective

To systematically compare success, cure and complication rates of urethral sling surgeries in stress urinary incontinence patients with and without a history of pelvic radiotherapy (RT).

Materials and methods

We searched PUBMED, EMBASE, and Web of Science to identify relevant articles. The primary outcomes were the success and cure rates. The secondary outcomes included the rates of infection, urethral erosion, total complications, explantation, and satisfaction. Outcomes were analyzed using a random-effects model to calculate the unadjusted odds ratio (OR) in patients with a history of RT compared with those without prior RT.

Results

On pooled analysis, we found significantly lower odds of success (OR 0.68; 95% confidence interval [CI] 0.53-0.87, P < .001) and cure (OR 0.67; 95% CI 0.55-0.82, P < .001) in radiated patients than in nonirradiated patients. Subgroup analysis by type of sling showed significantly lower odds of success in Advance subgroup (OR 0.66; 95% CI 0.45-0.95, P < .001) and significantly lower odds of cure in Advance (OR 0.59; 95% CI 0.36-0.95, P < .001) and Atoms subgroups (OR 0.70; 95% CI 0.54-0.93, P < .001). We also found significantly greater odds of sling explantation (OR 2.93; 95% CI 1.62-5.29, P < .001) and infection (OR 3.06, 95% CI 1.03-9.07, P < .001) in radiated patients than in nonradiated patients.

Conclusion

Patients with a history of pelvic RT have lower odds of success and cure and higher odds of infection and sling explantation than those without a history of pelvic RT.

Abstract: Introduction: Though urinary incontinence (UI) after prostate treatment often contributes to emotional distress and significantly impacts quality of life, many patients do not discuss this condition with their physicians. We analyzed the patient perspective by examining online support group posts to gain insight into specific challenges associated with different UI management methods. Methods: We examined discussion board threads from multiple patient‐focused forums on experiences of UI due to prostate treatment (threads from January 2016 to January 2022). Principles of grounded theory in thematic analysis were used to analyze the threads. Results: Three hundred and eighteen posts from 84 unique users were analyzed. Among users, 47 (56%) reported UI following radical prostatectomy (RP), 5 (6%) secondary to radiation therapy (RT), 12 (14%) after a combination of RP and RT, and 20 (24%) were ambiguous. UI management methods included pads/diapers/liners, condom catheters/external clamps, Kegels/pelvic floor physiotherapy, and surgical treatment (artificial urinary sphincter or sling placement). We identified challenges common to all management methods: “requires trial and error,” “physical discomfort,” and “difficult to be in public.” Factors influencing management choices included the ability to “feel normal” and the development of a management routine. Conclusion: The current study identifies opportunities for improved expectation‐setting and education regarding post‐procedural UI and its management. These findings can serve as a guide for providers to counsel patients on the advantages and disadvantages of UI management devices.

This cross-sectional analysis examined online US crowdfunding campaigns from 2010–2018. Campaigns including prostate, breast, bladder, kidney, cervical, uterine, ovarian, testicular, oral, and thyroid cancers were included. Multivariable modeling was utilized to examine predictive factors for successful campaigns. A total of 1830 online cancer campaigns were included in the final analysis. Breast cancer was estimated to be the most frequent online campaign type (n = 3682), followed by cervical (n = 492), kidney (n = 475), ovarian (n = 460), and prostate cancers (n = 382). Breast cancer campaigns generated the most total funding ($15.3 million). In adjusted models, breast cancers generated significantly more donations per campaign than any other cancer. There was no difference in the average amount of funds raised per campaign by most cancer types, except for thyroid (19.4% less than breast, p < 0.001). Friend-authored campaigns generated more funding than self- and family-authored. Male cancers are under-represented, and breast cancer campaigns are disproportionately over-represented in online medical crowdfunding and generate more donations than many other cancers. Gendered differences in cancer crowdfunding are likely multifactorial and may be influenced by social networks and public health campaigns.