Aims: To assess the effectiveness of a polyacrylamide hydrogel (PAHG; Bulkamid 1 ) in treating recurrent stress urinary incontinence (SUI) following a previous midurethral sling (MUS) implant. Methods: This observational study, conducted since 2009, included 60 patients with recurrent SUI or mixed urinary incontinence (MUI) after a previous MUS and who chose to be treated with PAHG. Objective and subjective outcomes were assessed at 1, 6, and 12 months after the initial injection. Patients were classified as cured based on a negative cough test (supine and standing) and <2 g urine on 1-hr pad test and a VAS score improved by !90%. Improved were those with the loss of only a few drops of urine during the cough test and 2-10 g urine on 1-hr pad test or a reduction >50% compared with preoperative urine loss and a VAS score improved by !75%. Results: The volume of PAHG injected in the current study ranged from 1-3 ml. Cured/improved rates were 93.3% (56/60), 88.3% (53/60), and 83.6% (46/55) at 1, 6, and 12 months, respectively. Patients with MUI had a cured urgency urinary incontinence rate of 36.8%, 47.4%, and 38.9%, respectively. Voiding dysfunction rates were 13.3% (8/60), 8.3% (5/60), and 1.8% (1/55) at 1, 6, and 12 months and urinary tract infection rates were 5% (3/60), 11.7% (7/60), and 3.6% (2/55), respectively. Other adverse events were short-term and/or observed in <4% of patients. Conclusions: PAHG can be used to treat recurrent SUI after MUS failure with good outcome and low complication rates. Neurourol.
The reduced cure rate for ISD patients was due to the subgroup with a hypomobile urethra. A prospective study is needed to confirm that slightly shorter tape-urethra distances and a relative tape position more toward the mid-urethra will lead to better outcomes for this patient group.
Aims
To evaluate the efficacy, sustainability and safety of combined botulinum toxin and polyacrylamide hydrogel (PAHG) therapy to treat urgency and stress components of therapy‐refractory mixed urinary incontinence (MUI) in an elderly study population.
Methods
Fifty‐five women with therapy‐refractory MUI were treated with botulinum toxin and PAHG in one surgical procedure. Urgency urinary incontinence (UUI) and stress urinary incontinence (SUI) outcomes were separately assessed after 4 and 12 months by objective UUI episodes/24 h and cough test, subjective impact of UUI and SUI on quality of life, and subjective International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form (ICIQ‐UI SF). MUI outcome was calculated by combining UUI and SUI outcomes. Complications were monitored throughout the study.
Results
At 4 months, objective cure rates were 73%, 53%, and 42%, and subjective cure rates were 71%, 52%, and 50% for SUI, UUI, and MUI. At 12 months, objective cure rates were 73%, 56%, 50% and subjective cure rates were 78%, 42%, and 40% for SUI, UUI, and MUI. The ICIQ‐UI SF score decreased by 9.0 and 8.7 points after 4 and 12 months. All complications were transient and included 22% clean intermittent catheterization immediately after surgery, 33% postvoid residual volumes >100 ml at 14 days, and 13% symptomatic urinary tract infection within the first postoperative month.
Conclusions
The combination of botulinum toxin and PAHG is effective, sustainable and safe to treat therapy‐refractory MUI, even in an elderly and frail study population. Patients benefit from the short surgical procedure without the need for general anaesthesia or discontinuation of anticoagulation.
Purpose
Vulvar lichen sclerosus (LS) is a chronic debilitating inflammatory skin disease. Today, the gold standard is a life-long topical steroid treatment. Alternative options are highly desired. We present a study protocol of a prospective, randomized, active-controlled, investigator-initiated clinical trial comparing a novel non-invasive dual Nd:YAG/Er:YAG laser therapy with the gold standard for the management of LS.
Methods
We recruited 66 patients, 44 in the laser arm and 22 in the steroid arm. Patients with a physician-administered clinical LS score ≥ 4 were included. Participants received either four laser treatments 1–2 months apart, or 6 months of topical steroid application. Follow-ups were planned at 6, 12, and 24 months. The primary outcome looks at the efficacy of the laser treatment at the 6-month follow-up. Secondary outcomes look at comparisons between baseline and follow-ups within the laser or the steroid arm, and comparisons between laser vs. steroid arm. Objective (LS score, histopathology, photo documentation) and subjective (Vulvovaginal Symptoms Questionnaire, symptom VAS score, patient satisfaction) measurements, tolerability, and adverse events are evaluated.
Conclusion
The findings of this trial have the potential to offer a novel treatment option for LS. The standardized Nd:YAG/Er:YAG laser settings and the treatment regime are presented in this paper.
Clinical trial identification number
NCT03926299.
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