View clinical trials related to Uterine Fibroids.
Filter by:The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.
The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.
Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique. This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months. The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.
The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram. This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy.
The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.
The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.
A prospective non-randomized open label clinical trial to research the efficacy and safety of sirolimus in patients with symptomatic, recurrent uterine fibroids or/and various rare leiomyoma.
Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention has been paid to the study of minimally invasive methods for treatment. Microwave ablation of myomas and endometrium has been shown to have good effect and acceptability has been high. This study aims to compare the effectiveness, feasibility and acceptability of percutaneous or per vaginal microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study. Primary outcome 1. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic Power calculation To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in microwave ablation and 50%[11] in the embolization group with a standard deviation of 25% with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to randomize 32 women. In order to compensate for loss to follow-up or drop out a total of 36 women will be randomized. Patients and investigators will not be blinded. The MRI will be performed and evaluated by a blinded radiologist. After having signed informed consent but before randomization patients will undergo MRI of the uterine fibroids. Patients with a single fibroid measuring more than mean diameter 8cm will be excluded from further participation in the study. All women included in the study after MRI examination will fill in a PBAC evaluation[7] during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month prior to treatment. Microwave ablation will be performed percutaneously or vaginally using a Covidien Emprint microwave ablation system. Embolization will be performed in conscious women with an epidural catheter for pain relief. At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the treatment to a friend. A new MRI scan will be performed 6 months post treatment (+/-15 days).
MRI-guided high intensity focused ultrasound (MRI-HIFU) has been proven to be a safe and effective method in treating uterine fibroids and also adenomyosis. However, systematic studies on the effect of this treatment on factors affecting fertility are still lacking. Also quite little is known about body's systemic response to MRI-HIFU. Thus the aim of this study is to obtain more information on the systemic response of the body to the HIFU-treatment when treating non-malignant disease as well as to study the effect of MRI-HIFU on factors affecting fertility. Women with symptomatic uterine fibroids or adenomyosis suitable for MRI-HIFU treatment are recruited to this study. The severity of symptoms will be assessed with UFS-QoL and the same questionnaire will also be used in follow-up 3, 6 and 12 months after treatment. Blood, urine and endometrium samples will be collected pre- and postoperatively and during follow-up 3, 6 and 12 months after the treatment. From these samples detailed analysis of the immunological, inflammatory and hormonal response will be performed. As this is the first study in Finland of treating uterine fibroids and adenomyosis using MRI-HIFU, also a report about the efficacy of the MRI-HIFU in treating the uterine disorders will be published, and a key tool in assessing the treatment outcome would be the UFS-QoL questionnaire. Also new methods for improving patient selection as well as treatment efficacy will be evaluated in this study.