View clinical trials related to Prolapse.
Filter by:The goal of this observational study is to learn about the therapeutic effects of different pelvic floor rehabilitation treatments, including pelvic floor muscle training , pelvic floor biofeedback electrical stimulation, and magnetic stimulation, in a population of Chinese patients with female pelvic floor dysfunction disorders. The study aims to find out the individualised pelvic floor rehabilitation treatment plan suitable for the Chinese population. The main question it aims to answer is: 1. Do patients with reduced pelvic floor muscle strength after childbirth, or patients with mild to moderate pelvic organ prolapse and symptomatic pelvic organ prolapse benefit from pelvic floor rehabilitation? 2. Is the combination of biofeedback electrical stimulation plus pelvic floor magnetic stimulation superior to single electrical stimulation, magnetic stimulation or pelvic floor muscle training? 3. Which pelvic floor rehabilitation therapy is most suitable for Chinese patients with female pelvic floor dysfunction? 4. What factors are early predictors of developing female pelvic floor dysfunction? And what factors can predict the prognostic status of patients treated with pelvic floor rehabilitation? Participants in the multicenter will be treated with different rehabilitation therapies, during which the researchers will collect clinical symptoms using the PFDI20 questionnaire, and POP-Q scores, pelvic floor muscle strength, and electromyography results from participants before, at the end of, and 3 months and 1 year after the end of treatment.
Rectal prolapse is a protrusion of rectal wall through the anus. A surgical technique called Ventral mesh rectopexy has become a standard procedure for this condition in many centers. The goal of this trial is to investigate functional outcome, recurrence rates and complications after ventral mesh rectopexy. The main question it aims to answer is: - Do bowel function, quality of life and sexual function improve after Ventral mesh rectopexy? Participants will: - be asked to fill in questionaires before surgery, 3-6 months after surgery and 12 months after surgery. - be examined by a surgeon 3-6 months, 12 months and 3 years after surgery.
Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death. On the other hand, other studies found MAD as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication. Cardiac Magnetic Resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. Additionally, Cardiac Magnetic Resonance (CMR) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small MAD. Therefore, in relation to the scarcity of data about MAD prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of MAD in patients submitted to CMR independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.
This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.
This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.
Patients who undergo anterior vaginal wall plastic surgery and place the bladder catheter during surgery are selected. The purpose of the study is to evaluate the presence of statistically significant differences in bladder catheter repositioning within 12 hours after bladder catheter removal in the group of patients in whom the bladder catheter is removed on postoperative day I or II. Secondary outcomes include evaluation of the incidence of urinary tract infections, number of hospitalization days and total hospitalization costs for patients undergoing anterior vaginal wall surgery in patients in whom the bladder catheter is removed on postoperative day I or II.
Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery.
Background: Pelvic organ prolapse is one of the most common benign gynecological disorders in middle-aged and elderly women, and it has a significant negative impact on women's social, physical, and psychological health. Sacrospinous ligament fixation (SSLF) is one of the main surgical procedures for reconstructing pelvic floor defects. In previous studies, the ischial spine fascia fixation (ISFF) technique developed by our team has been shown to be a safe and effective alternative to SSLF. However, both procedures have inadequate support for the anterior vaginal wall. Therefore, based on the traditional ISFF, we fix the anterior vaginal wall to the ipsilateral ischial spine fascia to enhance support for the anterior vaginal wall. This modified procedure is called modified ISFF. This trial aims to compare the subjective and objective therapeutic effects, recurrence rates, quality of life, perioperative parameters, and complications of modified ISFF and SSLF in the treatment of patients with pelvic organ prolapse of degrees II-IV. Methods: This trial is a randomized controlled multicenter non-inferiority trial. The primary outcome measure is the composite surgical success rate at one-year follow-up, defined as the absence of subjective vaginal bulge symptoms, no need for retreatment, and absence of POP-Q points at or beyond the hymen or vaginal introitus, i.e., Aa, Ba, C, Ap, Bp all < 0 cm. The secondary outcomes include anatomical outcomes of each vaginal segment based on the POP-Q score, subjective improvement in quality of life evaluated by questionnaires (PFIQ-7, PFDI-20, PISQ-12, and PGI-I), perioperative parameters (operation time, blood loss, length of hospital stay, pain VAS score, hospital costs), and complications. Data analysis will be conducted according to the intention-to-treat principle. Based on a composite success rate of 88% and a non-inferiority margin of -10% (one-sided α = 0.025, β = 0.2), 370 patients will be recruited from 9 centers, including a 10% dropout rate. The purpose of this study is to investigate whether modified ISFF is non-inferior to SSLF in terms of clinical efficacy and complications. Discussion: This multicenter non-inferiority trial will evaluate the effectiveness and safety of modified ISFF compared to SSLF in symptomatic patients with degrees II-IV uterovaginal prolapse. If modified ISFF is proven to be non-inferior to SSLF, it would be a preferable alternative for patients with a shorter vaginal length and those who have difficulties with SSLF due to anatomical factors.
Pelvic organ prolapse (POP) is one of the common benign gynecological disorders in middle-aged and elderly women, which severely affects patients' quality of life and increases the social burden. The lifetime risk of undergoing surgery for POP is 12.6%. Surgery is an important treatment modality for POP, and currently, there are various surgical procedures used in clinical practice, but there is still no clear consensus on which procedure is superior. Autologous tissue repair remains crucial in pelvic floor reconstruction surgery, and high uterosacral ligament suspension (HUSLS) via a vaginal approach is a classic corrective procedure for central pelvic defects. However, with the development of minimally invasive techniques, laparoscopic uterosacral ligament suspension (LUSLS) has been widely used in the field of pelvic floor reconstruction. Compared to the vaginal approach, LUSLS is easier to perform, has a shorter learning curve, provides better exposure of the ureters, and allows for higher-quality suture placement under safe conditions. The main controversial clinical issue in the industry regarding high uterosacral ligament suspension is whether to perform uterine preservation, with the core concern being the risk of postoperative recurrence. High uterosacral ligament suspension with uterine preservation achieves level I repair by fixing the lower segment or cervix to supporting structures. Its advantages include shorter operation time, less blood loss, and the preservation of the patient's fertility. Many women request uterine preservation for various reasons. Therefore, high-quality research is needed to guide the clinical decision-making regarding uterine preservation in high uterosacral ligament suspension. Previous studies have found that approximately 40% of patients with pelvic organ prolapse have concurrent cervical elongation. For patients with cervical elongation, symptoms in the central pelvic region are mainly caused by the protrusion of elongated cervical tissue into the vagina. Removing the elongated cervix significantly reduces the need for biological support in pelvic floor reconstruction, making autologous tissue repair strategies the preferred option for this patient population while providing a foundation for uterine preservation. Based on long-term observational studies, the Department of Obstetrics and Gynecology at Peking Union Medical College Hospital has proposed combining laparoscopic uterosacral ligament suspension with cervical amputation for the treatment of pelvic organ prolapse with cervical elongation. This study aims to compare whether uterine preservation in laparoscopic uterosacral ligament suspension is non-inferior to uterine removal, providing more treatment options for future patients with pelvic organ prolapse and cervical elongation.
Pessaries are effective non-surgical devices for reduction of prolapse. However, use of pessaries are limited in some women due to patient discomfort. While lidocaine can be used to improve pessary checks, its use may be limited due to supply chain shortages, lack of insurance coverage, and optimization of resource utilization. More techniques to improve pessary examination comfort are needed. Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort, theoretically by desensitizing the nerve endings in the skin, broadening the vaginal opening, and increasing elasticity of the perineal tissue. Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus, perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks. The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial. Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study. The study will involve two clinical visits. At the first visit, the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule, as well as internal massage with the thumb, gliding from 4 to 8 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock positions three times; versus application of gel to the internal vagina and external vagina without massage. Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols. Patients will rate self-reported pain before, during pessary check, and after the pessary check on a VAS scale; and rate whether they would prefer to repeat this method at future visits via Likert scale. Healthcare professionals will also rate perceived patient pain on VAS scale; ease of pessary removal; and note any perineal or introital laceration or abrasion that may occur during the pessary fitting. At the following visit, patients will be assigned to the group to which they were not initially randomized. Patients and healthcare professionals will again rate pain as described above. Patients will also rank preference for perineal massage using PGI-I.