Dataset Information

A Study Protocol of Micro-Ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

ABSTRACT:

Introduction

This is a presentation of a study protocol in order to evaluate whether the application of CO2 laser can additionally benefit the improvement of the symptoms of overactive bladder in postmenopausal women who have just started mirabegron as a treatment.

Materials and methods

This is a study protocol of a randomized double-blind placebo-controlled trial. A total of 50 menopausal women will participate in the study. All patients will start treatment with mirabegron 50 mg and will be randomized into two groups. Women in group A (control) will undergo CO2 laser treatments while those in group B (placebo group) will receive placebo CO2 laser treatments. In total, three monthly sessions will be held in both groups. The monitoring and evaluation of the results will be carried out by completing a three-day urination diary, as well as by completing the Female Lower Urinary Tract Symptoms, Overactive Bladder Questionnaire, King's Health Questionnaire, Urinary Distress Inventory, Pelvic Floor Impact Questionnaire, Patient Global Impression of Improvement, before each session and a month after the last one. Differences between groups will be assessed at baseline and every month following the three laser therapies.

Results

This is an ongoing study protocol, and we are expecting the analysis of the results in 2024.

Conclusions

The use of laser CO2 in postmenopausal women with overactive bladder syndrome may be a well-tolerated alternative treatment. The goal of our study is to evaluate the efficacy of laser treatment in combination with b3-adrenoreceptor agonist therapy.

SUBMITTER: Kypriotis K

PROVIDER: S-EPMC10711688 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Publications

A Study Protocol of Micro-Ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

Kypriotis Konstantinos K Zacharakis Dimitris D Kathopoulis Nikolaos N Diakosavvas Michail M Kalantzis Christos C Prodromidou Anastasia A Athanasiou Stavros S Grigoriadis Themos T

Cureus 20231111 11

<h4>Introduction</h4>This is a presentation of a study protocol in order to evaluate whether the application of CO2 laser can additionally benefit the improvement of the symptoms of overactive bladder in postmenopausal women who have just started mirabegron as a treatment.<h4>Materials and methods</h4>This is a study protocol of a randomized double-blind placebo-controlled trial. A total of 50 menopausal women will participate in the study. All patients will start treatment with mirabegron 50 mg ...[more]

PMID: 38090432

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Project description:BackgroundPrevious work has shown that the vaginal microbiome decreases in Lactobacillus predominance and becomes more diverse after menopause. It has also been shown that estrogen therapy restores Lactobacillus dominance in the vagina and that topical estrogen is associated with overactive bladder symptom improvement. We now know that the bladder contains a unique microbiome and that increased bladder microbiome diversity is associated with overactive bladder. However, there is no understanding of how quickly each pelvic floor microbiome responds to estrogen or if those changes are associated with symptom improvement.ObjectiveThis study aimed to determine if estrogen treatment of postmenopausal women with overactive bladder decreases urobiome diversity.Study designWe analyzed data from postmenopausal participants in 2 trials (NCT02524769 and NCT02835846) who chose vaginal estrogen as the primary overactive bladder treatment and used 0.5 g of conjugated estrogen (Premarin cream; Pfizer, New York City, NY) twice weekly for 12 weeks. Baseline and 12-week follow-up data included the Overactive Bladder questionnaire, and participants provided urine samples via catheter, vaginal swabs, perineal swabs, and voided urine samples. Microbes were detected by an enhanced culture protocol. Linear mixed models were used to estimate microbiome changes over time. Urinary antimicrobial peptide activity was assessed by a bacterial growth inhibition assay and correlated with relative abundance of members of the urobiome.ResultsIn this study, 12 weeks of estrogen treatment resulted in decreased microbial diversity within the vagina (Shannon, P=.047; Richness, P=.043) but not in the other niches. A significant increase in Lactobacillus was detected in the bladder (P=.037) but not in the vagina (P=.33), perineum (P=.56), or voided urine (P=.28). The change in Lactobacillus levels in the bladder was associated with modest changes in urgency incontinence symptoms (P=.02). The relative abundance of the genus Corynebacterium correlated positively with urinary antimicrobial peptide activity after estrogen treatment.ConclusionEstrogen therapy may change the microbiome of different pelvic floor niches. The vagina begins to decrease in diversity, and the bladder experiences a significant increase in Lactobacillus levels; the latter is correlated with a modest improvement in the symptom severity subscale of the Overactive Bladder questionnaire.

Dataset Information

A Study Protocol of Micro-Ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

Introduction

Materials and methods

Results

Conclusions

Publications

A Study Protocol of Micro-Ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

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