Study Type – Therapy (case series)Level of Evidence 4What's known on the subject? and What does the study add?Female urethral stricture disease has been described for almost 200 years. The symptoms of female stricture disease may range from clinically insignificant to severe and debilitating with the exact aetiology being unclear. No strict criteria for diagnosis have been established with the diagnosis often relying on a combination of presenting symptoms and objective findings. Initial therapy for female urethral stricture disease has often rested on urethral dilatations and self‐intermittent catheterisation with surgery reserved for patients that failed conservative measures. Female urethroplasty currently is a topic of increasing attention with multiple surgical approaches described including use of both grafts (vaginal wall, buccal mucosal membrane, lingual mucosa, and labia minus) and flaps (vaginal vestibule, anterior vagina, and lateral vagina).We describe our approach to female urethroplasty using a suprameatal (dorsal) approach (described by Tsivian and Sidi) with an autologous vaginal epithelium inlay graft. The technique and modern approaches to female urethroplasty are contrasted and discussed. The success of the approach including continence rates and lack of need for long‐term self‐intermittent catheterisation is noted.OBJECTIVE To review the technique and outcomes of using a dorsal vaginal graft to perform urethroplasty for the treatment of urethral strictures in women. PATIENTS AND METHODS This is a retrospective chart review of 11 women who were treated with a dorsal vaginal graft urethroplasty by one surgeon. All women underwent preoperative evaluation that included history, physical examination, fluoro‐urodynamics and urethral calibration. After surgery interviews, physical examinations, and urinary flow and postvoid residual urine volumes (PVRs) were obtained. RESULTS In all, 11 women who had undergone dorsal vaginal graft urethroplasty were identified for review. The mean (range) age was 60.6 (39–75) years. The mean (range) follow‐up was 22.7 (6–46) months. There were no cases of new onset stress urinary incontinence. The mean PVRs before and after surgery were 187.1 mL and 75.8 mL, respectively (P= 0.003). The mean urinary flows before and after surgery were 7.3 mL/s and 21.8 mL/s, respectively (P= 0.001). No patient has required repeat surgery. Self‐reporting satisfaction scores using the Patient Global Impression of Improvement showed that four patients scored 1 (very much better), three scored 2 (much better), two patients scored 3 (a little better), and one scored 4 (no change). Only one patient scored a 5 (worse). CONCLUSION Dorsal graft urethroplasty with vaginal mucosa may be considered as a first‐line option for definitive management of female urethral stricture disease. No consensus exists for the surgical treatment of female urethral stricture disease.
Purpose: A novel leadless tibial nerve stimulator provides a primary batterypowered, coin-sized, minimally invasive option to deliver automatic low-duty cycle stimulation for overactive bladder syndrome therapy. A pivotal trial was conducted to evaluate the safety and efficacy of this investigational device, eCoinÒ, for treating refractory urgency urinary incontinence. Materials and Methods: This was a prospective, open-label, single arm trial carried out at 15 U.S. medical centers involving 137 subjects with refractory urgency urinary incontinence. After implantation in the lower leg above the fascia over the tibial nerve, eCoin delivered automated stimulation sessions for the duration of the study. The primary efficacy measure was the proportion of subjects who achieved a 50% or greater reduction from baseline in urgency urinary incontinence episodes after 48 weeks of therapy. The primary safety measure was device-related adverse events at the same time point. Results: Of 137 subjects enrolled, 133 were implanted with eCoin, and 132 were included in the intention-to-treat population. Of those 132 subjects, 98% were female, meanAESD age was 63.9AE10.9 years, and baseline daily urgency urinary incontinence episodes were 4.3AE3.1. The primary efficacy analysis showed 68% (95% CI: 60%e76%) of subjects experienced at least a 50% reduction in urgency urinary incontinence episodes at 48 weeks post-activation; 16% of implanted subjects experienced device-related events through 52 weeks post-implantation. Conclusions: eCoin demonstrated clinical benefit for treating overactive bladder syndrome with automatic delivery of an intermittent low-duty cycle and implanted with a minimally invasive, brief procedure.
We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month (P=.004) and increased to 4 at 3 months (P=.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P=.007) and Urogenital Distress Inventory (from 10 to 5; P=.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P<.001) and 3 (14%; P=.004) women reported severe scores at 1 and 3 months, respectively. Direct instillation of botulinum toxin/DMSO solution is safe. Its promising clinical effect warrants further evaluation in a randomized, placebo-controlled phase 3 setting.
Millions of men suffer from overactive bladder and lower urinary tract symptoms. The adverse effects on quality of life and costs associated with the condition have been well described. In men, the pathophysiology of lower urinary tract symptoms may be from a number of causes including bladder outlet obstruction, detrusor overactivity, or both. Increasing data and clinical experience support the efficacy and safety of anticholinergics in men; the rate of urinary retention has been equal to that of placebo in short-term studies. Urodynamics play a vital role in defining the bladder and/or outlet dysfunction and help direct one's therapy.
Background Methadone is a drug infrequently used in palliative care with complex pharmacokinetics and a risk of adverse effects (AEs) on switching. There is a paucity of evidence-based guidelines for methadone use within palliative care. Aims This systematic review evaluated the evidence for the different methods used to switch to methadone and the need for ECG monitoring as part of this. Guidelines for switching were formulated on the basis of this. Methods Two systematic reviews were carried out by searching EMBASE, MEDLINE, Cochrane and DARE databases; journals and reference lists identifying randomised controlled trials (RCT) or prospective studies comparing different methods of switching to oral methadone and the need for ECG monitoring as part of this process. SIGN methodology was used to develop guidelines. Results Twelve studies met the inclusion criteria. Of these, only one compared two methods of switching. The remainder
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