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.

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.

Mirabegron versus Solifenacin in Children with Overactive Bladder: Prospective Randomized Single-Blind Controlled Trial

<b><i>Purpose:</i></b> The purpose of this study is to investigate the efficacy and safety of mirabegron versus solifenacin in the treatment of newly diagnosed overactive bladder (OAB) in children. <b><i>Methods:</i></b> We conducted a prospective randomized controlled study on pediatric patients with newly diagnosed OAB. Patients were randomized into 3 groups: mirabegron (50 mg once daily) in group I, solifenacin (5 mg) in group II, and placebo in group III. Before starting our treatment and at the end of the 3 months course, we obtained a 3-day voiding diary. This diary included incontinence episode per day, mean voided volume per micturition, mean number of micturition per day, and post-void residual urine. Moreover, the parents/patients were asked to rate symptom relief, and the adverse events were recorded throughout the study period. <b><i>Results:</i></b> A total of 190 patients aged from 5 to 14 years completed this study. At the end of this trial, both groups I and II showed significant improvement versus placebo regarding our efficacy parameters with no significant difference between group I and II. The overall success rate based on assessment of symptom relief was significantly higher in the treated groups (87.5% in I and 90.2% in II) versus placebo (55.8%). Dry mouth was reported in 2.8, 10, and 0% and constipation in 2.8, 11.4, and 1.4% in group I, II, and III, respectively, without statistically significant difference between group I and placebo. However, there was a significant difference between group II and placebo regarding these side effects. <b><i>Conclusion:</i></b> Both mirabegron and solifenacin have comparable efficacy regarding the control of OAB symptoms in the newly diagnosed children, but mirabegrone seems to have less side effects.

Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial

IntroductionEvidence specific for stress-predominant mixed urinary incontinence is still lacking at present, and acupuncture may relieve the symptoms. We plan to conduct this multi-centre, three-armed, randomised controlled trial to investigate the efficacy and safety of electroacupuncture among women with stress-predominant mixed urinary incontinence.Methods and analysisThe trial will be conducted at five hospitals in China. Two hundred thirty-two eligible women will be randomly assigned (2:1:1) to the electroacupuncture, sham electroacupuncture or waiting-list group to receive either 24-session acupuncture/sham acupuncture treatment over 8 weeks and 24-week follow-up or 20-week watchful waiting. The primary outcome is the proportion of participants with at least 50% reduction in mean 24-hour stress incontinence episode frequencies from baseline to week 8. The outcome will be analysed with the intention to treatpopulation (defined as participants randomised) with a two-sided p value of less than 0.05 considered significant.Ethics and disseminationThe protocol has been approved by Guang’anmen Hospital Institutional Review Board (2019-241-KY). Detailed information of the trial will be informed to the participants, and written informed consent will be obtained from every participant. Results of the trial are expected to be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT04299932).

Mirabegron a novel approach in the management of overactive bladder

Many prescriptions are available for the therapy of the overactive bladder, yet assessing and choosing the correct medication is essential. The study was carried to examine whether Mirabegron could be the drug that can be used effectively in treating overactive bladder. To assess the effectiveness of Mirabegron, the field survey for this project was conducted through a structured questionnaire form the doctors in Bengaluru for about two months with the Support of Micro Labs Pvt. Ltd by involving 44 leading Doctors in the City from February- March 2020. The Survey population was chosen based on convenient random sampling. The analysis was done based on the occurrence of overactive bladder observed in their clinical practice every month, the age group, and the gender, who are being affected. It evaluated Mirabegron as a treatment option for incontinence episode and micturition frequency. Results showed noteworthy improvement in the quantity of incontinence episode and the quantity of micturition recurrence by utilising Mirabegron. The study outcomes indicated that Mirabegron promising effect in the management of overactive bladder.

Effect of Virgin Coconut Oil on Skin Integrity in The Elderly with Incontinence

Intorduction:Incontinence was a problem that often occurs in the elderly and this condition can worsen the elderly situation with the appearance of severe damage to the integrity of the skin,Virgin Coconut Oil (VCO) contains medium chain saturated fat that easily enters deep skin layers and maintains skin elasticity and suppleness. The aim of this study was to determine the effect of virgin coconut oil on skin integrity in the elderly with incontinence.Methods: The design of research was a quasi-experimental with non equivalent control group design. The population in this study were all elderly who experience incontinence. The sampling technique used was consecutive sampling with a total of 10 people in the experimental group and 10 people in the control group. To assess skin integrity before and after treatment is used was The Ghent Global IAD (GLOBIAD) tool. The using of virgin coconut oil is done every time after the stool incontinence episode and after bathing. Virgin coconut oil has been applied to the damaged skin and also to other vulnerable skin. Results: Based on the Wilcoxon test results obtained p value smaller than 0.05 which is 0.010 so that there was a significant difference in the value of skin integrity before and after the treatment. Conclusions:There was a significant effect on the use of virgin coconut oil on skin integrity in the elderly with incontinence.

Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies

ObjectiveTo compare the efficacy of electroacupuncture (EA) in elderly and non-elderly women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI).MethodsThis study was a secondary analysis of two randomised controlled trials involving 252 women with SUI and 132 women with stress-predominant MUI who were treated with the same EA regimen. Elderly women were defined as those aged >60 years. The main outcome measure was the proportion of patients with ≥50% decrease in the mean 72-hour urinary incontinence episode frequency (IEF) from baseline to week 6. Overall, 1004 women were recruited in the SUI and MUI trials. In the EA group, those with urge-predominant or balanced MUI at baseline were excluded from the current study, resulting in a sample size of 384.ResultsOut of 384 patients with SUI or stress-predominant MUI who were treated with EA, 371 completed the study. After 6-week treatment, the proportion of women who achieved ≥50% decrease in mean 72-hour IEF from baseline was 57.3% (51/89) in the elderly group and 60.70% (173/285) in the non-elderly group; the between-group difference was not significant (3.11%, 95% CI −9.83% to 16.05%; p=0.637). Similar outcomes were observed at weeks 4, 16 and 28. Both groups showed reduction in the 72 -hour IEF, amount of urine leakage (assessed by 1-hour pad test) and International Consultation on Incontinence Questionnaire-Short Form score from baseline with no significant between-group difference. No obvious EA-related adverse events were observed during the study.ConclusionEA may be an effective and safe alternative treatment for SUI or stress-predominant MUI in both elderly and non-elderly women. Age may not affect the treatment outcomes of acupuncture.Trial registration numerNCT01784172, NCT02047032.

Risk Factors for Urgency Incontinence in Women Undergoing Stress Urinary Incontinence Surgery

Objective.To determine baseline variables associated with urgency urinary incontinence (UUI) in women presenting for stress urinary incontinence (SUI) surgery.Methods. Baseline data from two randomized trials enrolling 1,252 women were analyzed: SISTEr (fascial sling versus Burch colposuspension) and TOMUS (retropubic versus transobturator midurethral sling). Demographic data, POP-Q measures, and validated measures of symptom severity and quality of life were collected. Charlson Comorbidity Index (CCI) and Patient Health Questionnaire-9 were measured in TOMUS. Multivariate models were constructed with UUI and symptom severity as outcomes.Results. Over two-thirds of subjects reported bothersome UUI at baseline. TOMUS patients with more comorbidities had higher UDI irritative scores (CCI score 0 = 39.4, CCI score 1 = 42.1, and CCI score 2+ = 51.0,P=0.0003), and higher depression scores were associated with more severe UUI. Smoking, parity, prior incontinence surgery/treatment, prolapse stage, and incontinence episode frequency were not independently associated with UUI.Conclusions. There were no modifiable risk factors identified for patient-reported UUI in women presenting for SUI surgery. However, the direct relationships between comorbidity level, depression, and worsening of UUI/urgency symptoms may represent targets for preoperative intervention. Further research is necessary to elucidate the pathophysiologic mechanisms that explain the associations between these medical conditions and bladder function.

Duloxetine in the Treatment of Stress Urinary Incontinence

Objective: To review the available literature regarding the use of duloxetine in the treatment of stress urinary incontinence. Data Sources: Clinical trials were obtained through a PubMed search (1966–December 2004) with the key words duloxetine, urinary incontinence, and stress. Data Synthesis: This article analyzes 5 clinical studies comparing duloxetine with placebo. The randomized, double-blind, multicenter trials were performed in the US and throughout the world and had strict inclusion criteria to enroll only patients with confirmed stess urinary incontinence. All trials showed a statistically significant decrease in incontinence episode frequency of 50–60% for duloxetine compared with a placebo response of 27–40%. Conclusions: Duloxetine appears to be an effective treatment for stress urinary incontinence. Additional trials comparing duloxetine with pelvic floor muscle training would better define duloxetine's place in therapy.