View clinical trials related to Prolapse.
Filter by:the main aim of this study is to study the anatomical and functional outcomes of two vaginal apical fixation procedures; sacrospinous ligament fixation and uterosacral ligament suspension, for pelvic organ prolapse surgery. The participants will be randomized to either of the surgical procedure and will be followed up for one year to study the outcome.
This is a single-center prospective cohort study sponsored by the University Hospitals Leuven (UZ). Women will undergo a pelvic floor ultrasound and will be asked to fill out a questionnaire at the time of their admission into the labour suite, at the postpartum check-up and 12 months postpartum. The primary objective is to correlate self-reported symptoms of Pelvic Floor Dysfunction (PFD) (binary outcome) at one year after delivery with structural changes to the Pelvic Floor Muscles (PFM) and postpartum evidence of levator avulsion (binary indicator) as measured by TransPerineal UltraSound (TPUS). Secondary objectives are to compare demographical and obstetrical variables between patients suffering from PFD symptoms or pelvic floor injury (documented one year after delivery) and those who do not; to record how patients manage and cope with PFD including recovery and compliance with Pelvic Floor Muscle Training (PFMT) as prescribed in the standard pathway of peripartum care; and to use of TPUS images for the development of artificial intelligence tools for automated image analysis. Primary outcomes are PFD symptoms one year after delivery and injury to the PFM evidenced by POP-Q and TPUS. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records. The presence and severity of PFD will be measured using standardized self-reporting tools: Pelvic Organ Prolapse Distress Index (POP-DI), Patient Assessment Constipation-SYMptoms (PAC-SYM), International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-SF), St. Mark's Incontinence Score (SMIS), Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R). FSFI is a widely used generic tool with sufficient granularity and validated in a large number of languages. FSDS-R assesses the construct "personal distress", which has been considered as an additional important aspect contributing to sexual dysfunction of women. PFD, as a clustered outcome, being the presence of any kind of pelvic floor dysfunction symptoms, will be defined as POP-DI score of ≥11 OR ICIQ-SF score of ≥1 OR SMIS score of ≥1 OR FSFI score ≤ 26.55 OR FSDS-R score ≥11.
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
Lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition. McKenzie's extension protocol is considered to be the gold standard physical therapy treatment for persons with acute discogenic low back pain, however the evidence is deficient in terms of additive benefits of sustained natural apophyseal glides in the management of discogenic low back pain. Thus, the current study will not only look into the positive effects of McKenzie's extension protocol in the management discogenic low back pain, but will also look into the additive benefits of sustained natural apophyseal glides in combination with McKenzie's extension protocol in the management of discogenic low back pain.
Comparison between Dynamic Cervical Implant as a recently introduced technique in our department and the conventional Anterior Cervical Discectomy and Fusion in management of single-level cervical disc prolapse.
This study is a prospective, multicentre, and randomized-controlled clinical study.The researchers wanted to explore the optimal treatment regimen for soft hemorrhoid within I-Ⅲ degrees by evaluating and comparing the effectiveness, safety and cost effect ratio of sclerosing injection and rubber lap ligation in patients with different internal hemorrhoid scores
Prolapse is a condition that causes up to 13% of women to have surgery in their lifetime. There are many surgical techniques for the treatment of prolapse, each with its advantages and disadvantages. The techniques by vaginal approach aim to put back in tension the supporting tissue, the endopelvic fascia, damaged and released. This technique has the advantage of not causing an abdominal scar, a quick recovery and often little pain. In contrast, the use of already damaged native tissue results in a recurrence rate of up to 15% to 30%. The other technique is the abdominal route either by laparotomy or by a minimally invasive approach such as laparoscopy, assisted or not by robotics. With this technique, we use prosthetic material introduced around the vaginal wall without opening the latter, therefore without contamination and without dissection of the vaginal wall. During upper surgery, a subtotal hysterectomy is performed, that is to say that the uterine cervix is preserved and serves as an anchoring point for the synthetic nets which are attached to the cervix and then sutured to the promontory of the sacrum. (sacrocervicopexy). In the vaginal route, a total hysterectomy is traditionally performed and the vaginal dome is sutured to the sacro-spinal ligament (Richter's operation). The stitches are then passed through the thickness of the often thin vaginal wall constituting a possible release point of the assembly. There are currently no studies that compare prosthetic sacrocervicopexy with fixation of the remaining cervix to the sacro-spinal ligament without prosthesis, and repair of the endopelvic fascia with native tissue. The study consists of performing a subtotal hysterectomy by minimally invasive approach in both cases and then randomize for either a prosthetic sacrocervicopexy or fixation of the remaining cervix to the sacro-spinal ligament via the abdominal or vaginal route.
Aim To compare the effectiveness of the application of non-ablative radiofrequency (RF) applied in combination with the usual treatment for the treatment of pelvic organ prolapse (POP) versus the usual treatment in lowering its severity. The secondary objective is to compare the effectiveness of both interventions in the symptoms most commonly associated with POP (pelvic heaviness, bulging, and prolapse-related lumbar pain). Design Randomized, double-blind clinical trial. Women between 18 and 75 years old with symptoms of vaginal prolapse, defined as "sensation of mass or lump" and / or "sensation of dragging in the vagina", and who also have the presence of POP diagnosed under clinical criteria and quantified using simplified POP-Q assessment. All women with asymptomatic vaginal prolapse grade IV or less than GI of the cervix or less than or equal to GI of the anterior and / or posterior vaginal Wall (asymptomatic); presence of more than one vaginal prolapse, and also those women with chronic connective tissue diseases or who present some type of contraindication to the application of RF therapy, will be excluded from the study Methods The study will include 20 women in the intervention group and 20 women in the control group. The women will be recruited from the patients who attend the Ketty Ruiz Pelviperineal Physiotherapy Clinic, which it´s specialized in treating pelvic floor dysfunctions. Interventions The usual intervention will be applied to both groups of the study. It will consist of supervised individualized sessions (up to a maximum of 8 sessions) by physiotherapists who are part of the research team. They will include the application of exercises to balance the pelvis and the muscles related to it, treatment of the trigger points detected through the application of manual and / or instrumental techniques, teaching of the activation of the transverse abdominis with ultrasound biofeedback and teaching of reflex activation exercises of the transverse abdominis and pelvic floor muscles in different body positions. The RF will be administered during the exercises of reflex activation of transversus abdominis and pelvic floor muscles on a stretcher (supine position). It will be applied intracavitary, in monopolar application, reaching a temperature between 42-45ºC in the tissues (according to the patient's tolerance), and with a power of 50% until the desired temperature is reached. It will be applied with a frequency that will be individualized according to the maximum level of energy absorption by the patient's tissues (between 0.8-1.2MHz) and with a dose of approximately between 3-4 KJ depending on the application time (20 minutes / session). In addition, they will be applied 1 session per week. The treatment will last 8 weeks. The application of RF in the control group will follow the same application procedure as in the intervention group, but in this case, no type of parameter is applied to the RF device, ie, the device remains off for the entire duration of the session. Variables: For the measurement of the main variable of the study, the simplified POP-Q will be used, considered the "gold standard" for the classification of POP. To measure the secondary variables of the study, the Pelvic Organ Prolapse Symptom Score (POP-SS) questionnaire will be used to assess the symptoms of pelvic bulging and / or heaviness; a visual analog scale (VAS) for the intensity of lumbar pain related to prolapse, the Prolapse Quality of Life (P-QOL) questionnaire for measuring the quality of life related to vaginal prolapse and finally structured interviews will be conducted with all study subjects throughout the duration of the study to assess the safety of the intervention The immediate effect (ie, at the end of the 1st treatment session) in the quantitative assessment of prolapse and the short-term effects (i.e. 1 week after the last face-to-face treatment session) and medium (at 3 and 6 months after end of treatment) and long-term effects (at 12 months after finishing treatment) in all study variables will be evaluated. Statistical analysis and ethical aspects It will be carried out using the SPSS 25.0 statistical package. This project is in process of being approved by the Research Ethics Committee (CEI) of the Balearic Islands (IB 4459/21 PS).
The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).
The purpose of the study is to assess the efficacy and safety of electroacupuncture among women with pelvic organ prolapse(Level II - III), compared with sham electroacupuncture.