Acupuncture for prostatectomy incontinence: study protocol for a multicenter single-blind randomized parallel controlled trial

Background Urinary incontinence is a common complication post radical prostatectomy. Acupuncture is considered an effective treatment for post-prostatectomy incontinence (PPI), but the evidence is still limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial. Methods Twenty hospitals will recruit 340 participants with urinary incontinence after radical prostatectomy in China from April 2021 to April 2022. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The study plan consists of 1-week baseline, 6-week treatment, and 18-week follow-up. Eighteen 30-min sessions of acupuncture or sham acupuncture treatment will be provided between weeks 1 and 6. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score at the week 6 from the baseline. Secondary outcomes include the change in volume of urine leakage at weeks 4 and 6 from a baseline measured using the 1-h pad test; 72-h incontinence episode frequency based on a 72-h voiding diary; change in the Expanded prostate cancer Index Composite scale (EPIC-26); change in the Self-Rating Anxiety Scale; weekly consumption of pads; and the severity of urinary incontinence based on a 72-h bladder diary and self-assessment of the therapeutic effect. The safety of acupuncture will also be assessed. Discussion This trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect. Trial Registration www.Chictr.org.cnChiCTR2100042500. Retrospectively registered on 22 January 2021.

Impact of the Treatment of Serenoa repens, Solanum lycopersicum, Lycopene and Bromelain in Combination with Alfuzosin for Benign Prostatic Hyperplasia. Results from a Match-Paired Comparison Analysis

Background: Phytotherapeutic agents aroused an increasing interest either as alternative or in addition to conventional therapy in the management of BPH. The aim of the article was to evaluate the clinical and functional changes after add-on treatment with Serenoa repens associated with Solanum lycopersicum, lycopene and bromelain in patients with BPH presenting with mild to moderate LUTS and previously treated only with Alfuzosin over a 6–12 months period. Materials and methods: Between January and July 2019, patients with symptomatic BPH already on treatment with Alfuzosin (Al) 10 mg for at least 6–12-month were enrolled at three academic referral centres, included in a prospective treatment group, and managed with a combination treatment of Al and 6-month daily oral single-tablet supplementation of Serenoa repens and Solanum lycopersicum + lycopene + bromelain (SeR + SL + Ly + Br). A retrospective control group with comparable baseline characteristics was obtained by performing a propensity score matching from a database of 434 patients managed with Alfuzosin 10 mg/day only over a 6–12 months period between March 2015 and December 2018. IPSS, QoL questionnaires, voiding diary assessment, postvoid residual volume (PVR), maximal (Qmax) and average (Qave) urinary flow rates were evaluated at baseline in the treatment group at the moment of patient accrual, in the control group after 6-month of treatment with alfuzosin, and thereafter at 3 and 6 months in both groups. Results: Overall, 250 patients entered the study (n = 125 treatment group; n = 125 control group). Total IPSS score significantly decreased at 6-month assessment from baseline in the treatment vs control group (17 [IQR: 12–20] vs 12 [IQR: 9–14], p = 0.02) with a significative storage symptoms improvement detected both at 3- (p = 0.03) and 6-month evaluation (p = 0.001). PVR significantly improved at each follow-up visit with the most relevant reduction at 6-month assessment (125 cc vs. 102 cc; p = 0.02). Moreover, a significative improvement in LUTS-related quality of life (QoL) was recorded at 3- and 6-month assessment with a median decrease of −1 and −2 (p = 0.05 and p = 0.001 respectively) from baseline. Conclusions: Combination treatment with AB and SeR + SL + Ly + Br led to meaningful improvements in LUTS severity compared to AB as monotherapy, after a 6-month treatment period in men with mild to moderate LUTS/BPH.

The role of the multi-disciplinary team and multi-disciplinary therapeutic protocol in the management of the chronic pelvic pain: There is strenght in numbers!

Introduction: The aim of the study is to evaluate the effectiveness of a Multi-disciplinary team (MDT) and multi-disciplinary approach in the treatment of Chronic Pelvic Pain (CPP). Methods: The data of all consecutive patients referred for a CPP from 11/2016 to 2/2019 has been prospectively collected. The sample was divided in two groups: Group A, made by patients managed after the institution of our MDT, and Group B, made of patients managed before this date. The MDT is composed by three urogynecologists, a psychologist and a physiotherapist. All Group A patients underwent a weekly bladder instillation with dimethyl sulfoxide (DMSO), kinesiotherapy for trigger points and Percutaneous Tibial Nerve Stimulation for 10 consecutive weeks. Patients were asked to perform a self-treatment following the Stanford Protocol and to adhere to a specific diet. All Group B patients were managed only with DMSO instillations and a strict diet. Results: The Group A was made of 41 females and 6 males while the Group B was made of 38 females and 5 males. The Group A patients showed a statistically significant improvement in the Pelvic Pain Urgency Frequency, in the frequency times reported at the 6 months voiding diary, and a better Patient Global Impression of Improvement. Conclusions: Our data support the efficacy of the MDT in the management of CPP. The multimodal approach might represent an effective and reproducible non-invasive option to manage successfully CPP.

Acupuncture for Prostatectomy Incontinence: Study Protocol for A Multicenter Single Blind Randomized Parallel Controlled Trial

Background: Urinary incontinence is a common complication after prostatectomy. Acupuncture is considered an effective treatment for prostatectomy incontinence (PPI), but evidence is still limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.Methods: Twenty hospitals will recruit 340 participants with urinary incontinence after prostatectomy in China from April 2021 to April 2022. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The study plan consists of 1-week baseline, 6-week treatment, and 18-week follow up. Eighteen 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between weeks 1 and 6. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score at the week 6 from the baseline. Secondary outcomes include the change in volume of urine leakage at weeks 4 and 6 from a baseline measured using the 1-h Pad Test;72-h incontinence episode frequency based on a 72-h voiding diary; change in the Expanded prostate cancer Index Composite scale (EPIC-26); change in the Self-Rating Anxiety Scale; weekly consumption of pads; the severity of urinary incontinence based on a 72-h bladder diary and self-assessment of the therapeutic effect. The safety of acupuncture will also be assessed.Discussion: This trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect.Trial Registration: The trial was registered on www.Chictr.org.cn. ChiCTR2100042500. Retrospectively registered on 22 January 2021.

Comparison of the diagnostic yield of routine versus indicated flowmetry, ultrasound and cystoscopy in women with recurrent urinary tract infections

Introduction and hypothesis To quantify and compare the outcomes of routine vs. urologist-requested diagnostic testing for recurrent urinary tract infections (rUTI). Methods A retrospective cohort study of patients with rUTI referred to a large non-academic teaching hospital between 2016 and 2018 (Hospital A) and a university hospital between 2014 and 2016 (Hospital B). Electronic medical records were reviewed for baseline and diagnostic data. Women underwent the following assessments routinely: urinalysis, voiding diary, flowmetry in Hospital A and urinalysis, voiding diary, flowmetry, ultrasound, abdominal x-ray and cystoscopy in Hospital B. All other diagnostics were performed by indication in each hospital. Results We included 295 women from Hospital A and 298 from Hospital B, among whom the mean age (57.6 years) and mean UTI frequency (5.6/year) were comparable, though more were postmenopausal in Hospital A. We identified abnormalities by flowmetry or post-void residual volumes in 134 patients (Hospital A: 79; Hospital B: 55), cystoscopy in 14 patients (Hospital A: 6; Hospital B: 8) and ultrasound in 42 patients (Hospital A: 16; Hospital B: 26), but these differences were not significant. Diagnostics altered treatment in 117 patients (e.g., pelvic floor muscle training, referral to another specialist, surgical intervention), mostly due to flowmetry and post-void residual volume measurement. The retrospective design and absence of follow-up data limit these results. Conclusions The routine use of cystoscopy and ultrasound in female patients with rUTIs should not be recommended as they yield few abnormalities and lead to additional costs.

Nocturnal Urine Production in Women With Global Polyuria

Purpose: Low nocturnal urine production (NUP) may be sufficient to rule out global polyuria (GP) in men. This study determines the sensitivity of indices for nocturnal polyuria (NP), defined as nocturnal polyuria index (NPi; nocturnal urine volume/24-hour urine volume) ≥0.33 or NUP ≥90 mL/hr, for detecting GP in women.Methods: Data were analyzed from 2 prospective protocols involving subjects recruited from a urology ambulatory care unit and a continence clinic. Women ≥18 years with nocturia were included if they met either of 2 common criteria for GP: (1) ≥40 mL/kg/24 hr or (2) ≥3,000 mL/24 hr.Results: Thirty-one women were included (NPi, 28.6 [21.3–40.7]; NUP, 100.8 [68.3–135.8] mL/hr). At the ≥40 mL/kg/24-hr cutoff, 40% and 63% of women reporting ≥1 nocturnal void(s) (n=30) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively. Additionally, 53% and 71% of subjects reporting ≥2 nocturnal voids (n=17) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively. At the ≥3,000 mL/24-hr cutoff, 38% and 69% of women reporting ≥1 nocturnal void(s) (n=13) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively, and 63% and 88% of subjects reporting ≥2 nocturnal voids (n=8) had NPi ≥0.33 and NUP ≥90 mL/hr, respectively. By extension, 37%–62% of women with nocturia and GP did not have NP by NPi ≥0.33 criteria, and 12%–37% did not have NP by NUP ≥90 mL/hr criteria.Conclusions: Indices of excess nighttime urination do not reliably predict GP in women. A full-length voiding diary may be particularly important in the evaluation of women with nocturia. Nocturia in women merits further consideration as a distinct entity.