Journal of Urology最新文献

Purpose: We assessed efficacy and safety of URO-902, an investigational gene therapy expressing the α subunit of the large-conductance Ca²⁺-activated K⁺ channel, in a phase 2a placebo-controlled trial in women with overactive bladder (OAB).

Materials and methods: Women, age 40 to 79 years, with OAB and urge urinary incontinence who were refractory to OAB medications were randomized to single-dose URO-902 24 and 48 mg or placebo administered by intradetrusor injection via cystoscopy under local anesthesia. Efficacy end points included change from baseline to week 12 in mean daily micturitions, urgency episodes, urge urinary incontinence episodes, and patient-reported outcomes. Safety assessments included adverse events and postvoid residual urine volume.

Results: Of 80 patients randomized (URO-902 24 mg, n = 26; URO-902 48 mg, n = 27; placebo, n = 27), 74 received treatment, and 67 reached week 24. At week 12, URO-902 24 and 48 mg were associated with significant improvement vs placebo in daily micturitions (least-squares mean change from baseline, -2.3 and -2.4 vs -0.8, respectively; least-squares mean difference [95% CI], ‒1.5 [‒2.7 to ‒0.3] and ‒1.6 [‒2.8 to ‒0.4], nominal P = .017 and P = .009, respectively). URO-902 48 mg was associated with significant improvements vs placebo in urgency episodes (‒3.4 vs ‒1.1; ‒2.2 [‒4.0 to ‒0.4]; nominal P = .016) and percentage of Patient Global Impression of Change responders (58% vs 31%; nominal P = .026). Among patients receiving URO-902 24 mg, URO-902 48 mg, and placebo, 46%, 54%, and 54%, respectively, experienced ≥ 1 treatment-emergent adverse events, most commonly UTI (0%, 15%, 4%) and hematuria (6%, 8%, 8%).

Conclusions: In this phase 2a trial, treatment with URO-902 was associated with improvements vs placebo in efficacy and patient-reported outcomes and was safe and well tolerated.

Purpose: Genitourinary rhabdomyosarcoma (GU-RMS) often requires multimodal therapy treatment including radiation, chemotherapy, and radical surgery for disease control. The long-term effects of the disease and associated treatments are unclear. We sought to investigate the long-term genitourinary quality of life for adult survivors of pediatric GU-RMS.

Materials and methods: In total, 14 participants (43% female, median age = 32.5 years [IQR = 23.25-39.25], range = 20-52 years, 2 bladder, 1 cervical, 5 paratesticular, 3 vaginal, 2 pelvic, and 1 prostate RMS) agreed to interview about impact of GU-RMS treatment during childhood on quality of life. A semistructured interview guide based on the long-term service and support quality-of-life model and grounded in known GU-RMS experiences was created. Two coders independently coded using thematic analysis methodology.

Results: Six themes emerged: (1) unknown fertility status; (2) lack of education; (3) relationships and difficult communication; (4) incontinence, clean intermittent catheterization, and a bag; (5) lifestyle and learned adaptation; and (6) threats to body image. Across these themes, participants reported insufficient knowledge regarding GU-RMS treatment and its impact on function. Participants were principally concerned with anatomical changes, fertility, pregnancy expectations, and survivorship challenges such as communication with romantic partners.

Conclusions: Survivors of GU-RMS have significant urinary and sexual function concerns that are important to address in long-term survivorship. Clinicians can potentially improve survivors' quality of life through open and honest age-appropriate education on expectations for treatment, fertility preservation options, and long-term effects of treatment.

Purpose: Although the provision of a survivorship care plan (SCP) has been recommended after prostate cancer (PCa) treatment, there have been no randomized controlled trials to examine their impact. The objective of this study was to evaluate the effect of a tailored PCa-SCP intervention provided to early-stage PCa survivors.

Materials and methods: A prospective, parallel 1:1 randomized controlled trial was conducted at 3 sites across Canada. Early-stage PCa survivors were randomized (n = 189; 64% response rate) to receive PCa-SCP intervention or usual care. Assessments were performed at baseline, 6 months, and 12 months. The primary outcome was change in patient activation (Patient Activation Measure-13); secondary outcomes included satisfaction with information, self-management support, prostate-specific quality of life, cancer worry, health care utilization, and health behaviors.

Results: For the primary patient activation analyses, no significant group-by-time differences were detected. There were significant between-group differences in (1) satisfaction with information from baseline to 6 months (mean [95% CI]: 7.13 [5.53-8.71]; effect size [ES], 0.34; P < .001) and baseline to 12 months (4.91 [3.06, 7.06]; ES, 0.19; P < .001); (2) social integration and support from baseline to 6 months (mean [95% CI]: 0.16 [0.06-0.26]; ES, 0.25; P = .002); and (3) skill and technique acquisition from baseline to 6 months (mean [95% CI]: 0.12 [-0.02 to 0.24]; ES, 0.33; P = .05). No other group-by-time differences were detected.

Conclusions: The PCa-SCP intervention did not have a significant effect on patient activation but did increase satisfaction with information and some aspects of self-management support. Although the benefits of the provision of an SCP alone remain unclear, the PCa-SCP intervention is likely a valuable tool that can be built upon as part of a comprehensive approach to enhance the quality of care for PCa survivors.

Trial registration: ClinicalTrials.gov Identifier: NCT03017456.