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NCT06168058
The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins. The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.
NCT06611501
The goal of this pilot trial is to learn if a novel non-hormonal treatment, metformin hydrochloride, works to treat pelvic pain in young women with endometriosis. The main questions it aims to answer are: * Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis? * Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis? Researchers will compare metformin to a placebo (a look-alike substance that contains no drug) to see if metformin works to treat pelvic pain. Participants will: * Take drug metformin or a placebo every day for 6 months * Visit the clinic three times: once at baseline (pre-treatment), once at 3 months, and once at 6 months * Keep a daily symptom diary to track pain, bleeding, and usage of any pain medications
NCT07393295
ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind study lasting 4 weeks (P1 investigation phase) after a 4-week run-in period. The study is followed by a 4-week extension phase (P2) in which all participants will be treated with active TENS. Randomization will be balanced according to a 1:1 ratio.
NCT07391930
The goal of this study is to evaluate whether a 12-week online supervised high-intensity interval training program can reduce menstrual pain and improve quality of life in women with primary dysmenorrhea. Participants will be divided into two groups: one receiving an educational workshop and the HIIT program, and a control group receiving only the workshop. Additionally, the study seeks to understand the personal experience of these women through weekly health diaries, exploring how the intervention affects their relationship with their bodies and their menstruation. The ultimate goal is to offer new, non-pharmacological evidence-based tools for managing menstrual pain.
NCT07324148
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a prevalent chronic urological disease. CP/CPPS severely impacts patients' quality of life. It is characterized by recurrent pelvic floor pain, lower urinary tract symptoms, and often accompanied by psychological issues and sexual dysfunction (duration ≥3 months, no confirmed infection/pathology). The investigators have completed a large-sample, multi-center randomized controlled trial (RCT) involving 440 patients with CP/CPPS before. The clinical trial confirmed the sustained efficacy of acupuncture for the symptoms of pain, lower urinary tract symptoms, and anxiety and depression among patients with CP/CPPS. However, the trial revealed no significant improvements in sexual dysfunction in the acupuncture group compared to the sham acupuncture group after 8 weeks of treatment.To address this limitation, the current study is designed, which aims to optimize the clinical acupuncture protocol for CP/CPPS and evaluate whether it can enhance outcomes for psychogenic erectile dysfunction (ED) associated. Additionally, mass cytometry and liquid suspension chip technology will be used to explore systemic and local immune mechanisms underlying acupuncture's effects for CP/CPPS. Functional magnetic resonance imaging (fMRI) and metabolomics will be integrated to analyze patients' systemic states from central nervous system and metabolic perspectives, comprehensively elucidating the multi-dimensional mechanisms by which acupuncture alleviates CP/CPPS.
NCT07274956
Deep infiltrating endometriosis (DIE) is a highly symptomatic form of endometriosis linked to severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Histologic studies suggest abundant neural elements in DIE nodules, but the relationship between nodule-level nerve fiber density and patient-reported pelvic pain remains insufficiently defined. This retrospective, cross-sectional study with prospective pathology re-review evaluates whether nerve fiber density in surgically excised DIE nodules correlates with pain severity and location. Women aged 18-55 who underwent surgery for DIE after inadequate response to medical therapy are included. Clinical data (demographics, gynecologic history, prior treatments) and standardized pain scores (VAS for pain domains) are abstracted from records. Archived blocks are recut; sections are stained with H\&E and immunolabeled (e.g., SOX-10) to quantify neural profiles and derive a nerve fiber density metric per nodule. Primary endpoint: association between nerve fiber density and pain intensity/localization. Secondary endpoints: relationships with lesion site/depth and other clinicopathologic variables; exploratory discrimination of severe-pain phenotypes. Statistics (χ²/Fisher, t/Mann-Whitney, Kaplan-Meier/Cox if applicable) use two-sided p\<0.05. This minimal-risk study uses existing records and archived tissue only; findings may inform counseling, nerve-sparing surgical planning, and future biomarker-driven, response-adapted trials.
NCT07182032
The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA. Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.
NCT07241637
This study aims to examine the effects of Tele-yoga on chronic pelvic pain, fatigue, and quality of life in patients diagnosed with endometriosis. It will be conducted as a single-center, randomized controlled experimental study design.
NCT04778631
Perineal pain is common after vaginal birth. Thermotherapy might be effective to limit postpartum perineal pain, thanks to the effects of local heating or cooling application. This study aims to evaluate the impact of thermotherapy during childbirth on postpartum perineal pain.
NCT06540560
This research is studying what things change the way people think about treatment for chronic pelvic pain (CPP). The study team is also interested in whether a web-based educational and self-management program for chronic pelvic pain changes how people think about chronic pelvic pain treatments. The program contains several different self-guided modules that include cognitive and behavioral structuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. The study hypothesis is that patients with CPP will report that prior treatment experiences and most trusted source of medical information will be associated with baseline perceptions of various CPP treatment modalities.
NCT05538689
In this project, the proposition is that the use of daily dosed Myfembree ( a combination of relugolix with estradiol and norethindrone acetate), FDA-approved medication to treat heavy menses fibroid-related symptoms, has the potential to delay the recurrence of fibroid symptoms, prolong the improved quality of life and delay the need for re-intervention after uterine sparing surgery versus the routine standard of care.
NCT07081971
This randomized controlled trial (RCT) evaluates the efficacy of Bioheat thermal patches in reducing post-procedural pain following Hysterosalpingo Foam Sonography (HyFoSy). HyFoSy is a common ultrasound-based diagnostic procedure to assess tubal patency and uterine cavity structure in women undergoing fertility workup. While generally less painful than HSG, many patients still report moderate to severe cramping and discomfort during and after the test. Thermal therapy has demonstrated effectiveness in reducing musculoskeletal and gynecological pain. Bioheat patches, approved by the Israeli Ministry of Health for menstrual pain relief, emit safe, low-grade heat (approximately 37-38°C) and may provide a non-invasive pain management strategy post-HyFoSy. Participants (n=80) will be women aged 20-45 undergoing HyFoSy. They will be randomly assigned to either the Bioheat intervention group or a placebo patch group, applied externally to the lower abdomen. The heat-producing patch contains iron and other safe materials that react with oxygen to emit continuous heat without electricity. Infrared radiation from the patch components may also promote local vasodilation and muscle relaxation. Pain assessment will use the validated Visual Analog Scale (VAS), collected post-procedure via follow-up SMS and phone contact. The study aims to quantify reduction in perceived pain, and potentially improve patient satisfaction with HyFoSy. Safety has been pre-established, with no reported adverse skin effects when used as instructed. Study duration is six months, following ethics approval at the OB-GYN ultrasound department of Shamir Medical Center.
NCT06062043
The goals of this pilot randomized clinical trial are three-fold: 1) to test the feasibility of conducting a larger randomized trial using a brief Acceptance and Commitment Training (ACT) group intervention for women veterans with pelvic pain compared to usual care; 2) assess treatment acceptability by women veterans, and 3) identify appropriate pain-related treatment outcomes for the larger randomized trial. Participants will be randomly assigned to participate in either the ACT condition or treatment as usual condition, complete three surveys (before, after, and 3-months after first survey), and complete a phone interview (if assigned to the ACT condition). Researchers will compare the ACT condition and treatment as usual condition to see if there are meaningful differences in health outcomes. Due to the small sample size and pilot nature of this study, significance testing will not be performed.
NCT05648253
Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy. This study seeks to evaluate the feasibility of a novel intravaginal device that delivers patient-controlled dilation (Hyivy device). The study is designed as a proof-of-concept single-arm pilot study. The primary objective is to assess safety and tolerability, while also evaluating changes in health-related quality of life and pelvic pain.
NCT06161805
The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain. Secondary endpoints are to assess pain scores, side-effects, quality of life, depressive symptoms and pain coping.
NCT04527003
The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) in patients with endometriosis. It is believed that CBD will improve both pain and quality of life. The study will last a total of 12 weeks and involve several onsite visits in addition to daily pain assessments.
NCT05670353
The objective of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabis extract in women with endometriosis who have already undergone hormonal contraceptive treatment and surgery without satisfactory response.
NCT02636972
This is a cross-sectional observational study. For participants resident in Adelaide, South Australia. The study consists of 3 visits to the Pain and Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH). A total of 56 participants will be recruited for this study.
NCT05761275
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery. The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation/aspiration and the quality of the histological analysis on surgical specimens will also be evaluated as secondary outcome.
NCT06388590
The objective of this study is to determine if alternative pain management strategies, namely acupuncture, may help reduce intensity of female pelvic pain compared to other pain control modalities. This research study will focus specifically on the Dragon's protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault. This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain.