The PRO-RCC study: a long-term PROspective Renal Cell Carcinoma cohort in the Netherlands, providing an infrastructure for 'Trial within Cohorts' study designs.

BACKGROUND: Ongoing research in the field of both localized, locally advanced and metastatic renal cell carcinoma has resulted in the availability of multiple treatment options. Hence, many questions are still unanswered and await further research. A nationwide collaborative registry allows to collect corresponding data. For this purpose, the Dutch PROspective Renal Cell Carcinoma cohort (PRO-RCC) has been founded, for the prospective collection of long-term clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs). METHODS: PRO-RCC is designed as a multicenter cohort for all Dutch patients with renal cell carcinoma (RCC). Recruitment will start in the Netherlands in 2023. Importantly, participants may also consent to participation in a 'Trial within cohorts' studies (TwiCs). The TwiCs design provides a method to perform (randomized) interventional studies within the registry. The clinical data collection is embedded in the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. PROMS entail Health-Related Quality of Life (HRQoL), symptom monitoring with optional ecological momentary assessment (EMA) of pain and fatigue, and optional return to work- and/or nutrition questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician. TRIAL REGISTRATION: Ethical board approval has been obtained (2021_218) and the study has been registered at ClinicalTrials.gov (NCT05326620). DISCUSSION: PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, PROMS and PREMS. By facilitating an infrastructure for the collection of prospective data on RCC, PRO-RCC will contribute to observational research in a real-world study population and prove effectiveness in daily clinical practice. The infrastructure of this cohort also enables that interventional studies can be conducted with the TwiCs design, without the disadvantages of classic RCTs such as slow patient accrual and risk of dropping out after randomization.

Construct, content and face validity of the camera handling trainer (CHT): a new E-BLUS training task for 30° laparoscope navigation skills.

PURPOSE: Assessing construct, face and content validity of the camera handling trainer (CHT), a novel low-fidelity training device for 30° laparoscope navigation skills. METHODS: We developed a custom-designed box trainer with clinically based graphic targets. A total of 117 participants, stratified according to their previous experience (novice, competent, expert), took part to a CHT session and subsequently were asked to fill out a survey to assess the impact of the CHT on their 30° laparoscope navigation skills. Sixty of them were also studied for task performance during a 1-h session, with multiple time measurements. RESULTS: All participants, regardless of the previous experience, significantly improved their performance after the CHT session. Regarding construct validity, the mean task performance on the last measurement for novice group was found to be comparable to the mean first attempt of both competent (p = 0.12) and expert (p = 0.24) participants. All participants agreed that "the CHT is a valid training tool" and that "the CHT should be part of the regular dry laboratory training sessions", assessing both face and content validity. Limitations include the need for assessment of predictive validity. CONCLUSIONS: The CHT is a valid training tool for 30° laparoscope navigation and thus should be considered as one of the fundamental exercises during basic laparoscopic hands-on training sessions for urologists.

Urethral meatus deformities in girls as a factor in dysfunctional voiding.

PURPOSE: Girls with an anterior deflected urinary stream (ADUS) cannot void in the ideal toileting position, resulting in lower success rates of behavioral training programs. Purpose was to study prospectively the clinical effects of surgical meatus correction for ADUS in girls with dysfunctional voiding (DV). METHODS: A cohort of 171 DV patients aged 6-12 years was investigated. All had recurrent urinary tract infections (UTIs), staccato or interrupted uroflow, and >10% residual urine on ultrasound. For study purposes, all underwent a urodynamic study (UDS) to confirm DV. ADUS was recognized at first examination in 55 patients (32%) and a dorsally directed meatal correction was performed to achieve a normal direction of the urinary stream. The non-ADUS group (116 girls) was given behavioral therapy (BT); however, a subgroup of 11 girls with ADUS was detected with persistent complaints after failed BT. These 11 girls also underwent a meatal correction. RESULTS: All DV complaints were resolved in 25 of the 55 (45%) girls from the original ADUS group and 8 of the 11 (73%) girls from the second group. During UDS, in the ADUS group free of complaints after meatal correction, a significantly higher P(max) (102 cmH(2) O) was found compared to those who did not benefit from correction (P(max) 76 cmH(2)O). CONCLUSION: In this study, 39% of female DV patients had ADUS complaints. After surgical correction, 50% were free of all complaints without requiring any further behavioral training. The fast recovery into a normal voiding pattern in these girls shows that a meatus deformity needs to be looked for in all girls presenting with DV.

An adjustable sling for the treatment of all degrees of male stress urinary incontinence: retrospective evaluation of efficacy and complications after a minimal followup of 14 months.

PURPOSE: In this retrospective study we evaluated the efficacy and complications of the Argus® adjustable sling for the treatment of various degrees of male stress urinary incontinence. MATERIALS AND METHODS: Retrospectively we evaluated continence and complications in 100 men with stress urinary incontinence consecutively treated with the Argus between April 2005 and October 2008. Incontinence was defined as mild (1 to 2 pads per 24 hours), moderate (3 to 5 pads per 24 hours) and severe (more than 5 pads per 24 hours). Patient evaluation included medical history, pad count, a quality of life score, Patient Global Impression of Improvement and visual analog scale measurements to determine satisfaction with continence and with treatment. Results and complications were evaluated 6 weeks after surgery and in December 2009. RESULTS: After a median followup of 27 months (range 14 to 57) the Argus was successful in 72% of patients (68 of 95). Mild incontinence was treated in 13, moderate incontinence in 46 and severe incontinence in 41 patients. Success rates stratified to degree of incontinence were 92% (12 of 13), 67% (29 of 43) and 67% (26 of 39), respectively. Complications occurred in 55% of patients and most were Clavien grade I to II. Visual analog scale measurements on continence and quality of life showed significant improvement. CONCLUSIONS: The Argus adjustable male sling is a valuable adjunct in the treatment of all degrees of stress urinary incontinence. Complications are not uncommon but are mostly Clavien grade I to II. Patients report significantly improved continence and quality of life after treatment.

Routine biopsies in pediatric circumcision: (non) sense?

OBJECTIVE: At our institute we usually send the foreskin after circumcision for pathological examination. Does this make sense or is it merely medical overconsumption? MATERIAL AND METHODS: A retrospective analysis was carried out of all pediatric patients who underwent a circumcision, from August 2005 to January 2008, for persisting pathological phimosis after treatment with topical steroids. Religious circumcisions were excluded. RESULTS: Balanitis xerotica obliterans (BXO) was diagnosed in 37 out of 135 biopsies (27%). In 19 of the 37 boys with pathological evidence of BXO (51%), the physical examination matched the pathology. Meatal stenosis was found in six cases; four were also diagnosed with BXO. CONCLUSIONS: In this study, 27% of all biopsies were positive for BXO. The results show that the diagnosis BXO must be based on biopsy, because clinical findings underestimated the incidence of BXO by almost 50%. BXO implies a higher incidence of meatal stenosis, urethral pathology and has a known association with penile carcinoma. We conclude that there is a place for routine biopsy of the foreskin after circumcision for pathological phimosis, taking into account the potential clinical consequences when BXO is diagnosed.