Dataset Information

Pilot study of fractional CO₂ laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors.

ABSTRACT:

Purpose

The objectives of this study were to evaluate the feasibility and efficacy of fractional CO₂ laser therapy in gynecologic cancer survivors.

Methods

This was a pilot, multi-institutional randomized sham-controlled trial of women with gynecologic cancers with dyspareunia and/or vaginal dryness. Participants were randomized to fractional CO₂ laser treatment or sham laser treatment. The primary aim was to estimate the proportion of patients who had improvement in symptoms based on the Vaginal Assessment Scale (VAS). Secondary aims included changes in sexual function assessed using the Female Sexual Functioning Index (FSFI) and urinary symptoms assessed using the the Urinary Distress Inventory (UDI-6).

Results

Eighteen women participated in the study, ten in the treatment arm and eight in the sham arm. The majority of participants had stage I (n = 11, 61.1 %) or II (n = 3, 16.7 %) endometrial cancer with adenocarcinoma histology (n = 9, 50 %). In total, 15 (83.3 %) of the participants completed all treatments and follow-up visit. There was no difference in the change in the median VAS score from baseline to follow-up. However, there was an improvement in change in the median total FSFI score with treatment compared with sham (Δ 6.5 vs -0.3, p = 0.02). The change in the median UDI-6 score was lower in the treatment arm (Δ -14.6 vs -2.1, p = 0.17), but this was not statistically significant. There were no reported serious adverse events.

Conclusions

Fractional CO₂ laser therapy is feasible in gynecologic cancer survivors, with preliminary evidence of safety. In addition, there was preliminary evidence of improvement in sexual function compared with sham treatment. Clinicaltrial.gov Identifier: NCT03372720 (OSU-17261; NCI-2017-02051).

SUBMITTER: Quick AM

PROVIDER: S-EPMC7773136 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundGenitourinary syndrome of menopause (GSM) involves vaginal dryness (VD), pain during sexual activity (SAPain), vaginal itching (VI), burning, pain, and symptoms in the urinary organs. Non-ablative radiofrequency (RF) is a type of current with electromagnetic waves with a thermal effect that generates an acute inflammatory process with consequent neocolagenesis and neoelastogenesis. We aimed to describe the clinical response to VD, SAPain, vaginal laxity (VL), VI, burning sensation, pain in the vaginal opening, urinary incontinence, sexual dysfunction, cytological changes, and adverse effects of non-ablative RF in patients with GSM.MethodsThis single-arm pilot study included 11 women diagnosed with GSM with established menopause. Patients with hormone replacement initiation for six months, who used a pacemaker, or had metals in the pelvic region, were excluded. Subjective measures (numeric rating scale of symptoms, Vaginal Health Index-VHI) and objective measures (vaginal maturation index-VMI, vaginal pH, sexual function by the FSFI, and urinary function by the ICIQ-SF) were used. A Likert scale measures the degree of satisfaction with the treatment. Five sessions of monopolar non-ablative RF (41°C) were performed with an interval of one week between each application. The entire evaluation was performed before treatment (T0), one month (T1), and three months (T2) after treatment. Adverse effects were assessed during treatment and at T1 and T2.ResultsThe symptoms and/or signs were reduced after treatment in most patients (T1/T2, respectively): VD 90.9%/81.8%, SAPain 83.3%/66.7, VL 100%/100%, VI 100%/100%, burning 75%/87.5%, pain 75%/75%, and VHI 90.9%/81.9%. Most patients did not show changes in VMI (54.5%) and pH (63.6%) at T1, but there was an improvement in VMI in most patients (54.5%) at T2. Nine patients were satisfied, and two were very satisfied at T1. The treatment was well tolerated, and no adverse effects were observed. There was an improvement in sexual function (72.7%) and urinary function (66.7% in T1 and 83.3% in T2).ConclusionIntravaginal RF reduced the clinical symptoms of GSM in most patients, especially during T1, and women reported satisfaction with treatment. The technique showed no adverse effects, and there were positive effects on sexual and urinary function. Trial registration This research was registered at clinicaltrial.gov (NCT03506594) and complete registration date was posted on April 24, 2018.

Project description:Introduction: Surgery for chronic anal fissure is challenging for every proctologist. Solving the pain by guaranteeing rapid and effective healing is the objective, but what is the price to pay today in functional terms? Though this result is nowadays partially achievable through interventions that include the execution of an internal sphincterotomy among the procedures, it is necessary to underline the high rate of patients who can present faecal incontinence. The aim of this study is to explore the effectiveness of scanner-assisted CO2 laser fissurectomy. Methods: From April 2021 to September 2021, all consecutive patients who affected by chronic anal fissure suitable for surgery, meeting the inclusion and exclusion criteria, were evaluated. All planned data were recorded before surgery, then at 24 h, 1 week, and 1 month follow-up. A scanner-assisted CO2 laser was used in this study to achieve a smooth and dried wound with a minimal tissue thermal damage, to ensure good postsurgical pain control, rapid and functional, elastic and stable healing, and to prevent potential relapses. Paracetamol 1 g every 8 h was prescribed for the first 24 h and then continued according to each patient's need. Ketorolac 15 mg was prescribed as rescue. Results: Mean pain intensity ≤3, considered as the principal endpoint, was recorded in 26 out of the 29 patients who enrolled in the study with a final success rate of 89.7% at 1-month follow-up. Pain and anal itching showed a statistically significant reduction while bleeding, burning, and maximum pain, and REALIS score showed a reduction too at the end of the follow-up period. Reepithelisation proved to be extremely fast and effective: 22 of 29 (75.9%) showed a complete healing and 5 showed a partial reepithelisation at 1-month follow-up. Discussion: Outcomes of this study showed that it is undoubtedly necessary to change the surgical approach in case of anal fissure. The internal sphincterotomy procedure must be most of all questioned, where the availability of cutting-edge technological tools must be avoided and offered only in selected cases. Scanner-assisted CO2 laser showed great results in terms of pain control and wound healing, secondary to an extremely precise ablation, vaporisation, and debridement procedures with minimal lateral thermal damage.

Dataset Information

Pilot study of fractional CO₂ laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors.

Purpose

Methods

Results

Conclusions

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Dataset Information

Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors.

Purpose

Methods

Results

Conclusions

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Pilot study of fractional CO₂ laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors.