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NCT07295782
Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery.
NCT06024109
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.
NCT06902909
This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.
NCT06524700
prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse
NCT02431897
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.
NCT04038099
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum cystometric capacity) and determine whether the use of intraurethral 2% lidocaine jelly meaningfully impacts pain/discomfort, filling metrics, and voiding metrics.
NCT05586984
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.
NCT04209036
Due to the inconclusive results on the benefits of 3D laparoscopic system present in literature, this prospective randomised pilot study aims to assess if the operative time of total laparoscopic hysterectomy (TLH) for benign indication performed by trainees could be reduced using 3D laparoscopy instead of standard laparoscopy.
NCT02888093
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. However, permanent suture use in this vaginal application can result in some minor complication such as persistent vaginal spotting, vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized delayed-absorbable sutures in order to avoid these complications. Retrospective studies are conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as permanent suture. There are currently no high-quality, prospective studies that have evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension. This study will recruit women scheduled to undergo USLS with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month follow up visit. Subjects and assessors will be blinded.
NCT02690220
The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.
NCT02921451
The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.
NCT04009694
The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy. Candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. The data collection occurred in January-June 2019 and ethical approval was granted by School Research Ethics, University of Salford. Treatment aims to ensure there is respect for their autonomy, treatment is fair (Justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence). Participants are required to complete a consent form prior to their initial session. To ensure methodological quality, the STROBE guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention. The trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. They are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent NICE guidelines. The outcome measures used will be the Pelvic Organ Prolapse symptom score (POPSS) and this will be documented before and after the 16 week period. Along side the POPSS, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.
NCT02547155
The purpose of the study is to compare the risk of being unable to urinate shortly after surgery, also called acute post-operative urinary retention (POUR) between spinal and general anesthesia in women who undergo outpatient pelvic organ prolapse with stress urinary incontinence surgery.
NCT00535301
The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.
NCT01823055
To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.
NCT00564083
This research protocol is a randomized controlled trial. It is being done to compare and find out the relative differences between the materials, (Pelivisoft) "natural organic mesh" to poly propylene mesh (Pelvitex) "manmade mesh" after a surgery known as sacral colpopexy. This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum). These materials are both FDA approved and widely used. The following objectives: anatomic outcomes, graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life, subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy will be evaluated. The study visits are all under standard of care. Study questionnaires are unique to the study and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one year visits The questionnaires are related to bowel function, bladder function, prolapse and sexual activity. Permission will be requested to contact the patient again 5 years after surgery. Contact in the future will in no way obligate the patient to participate. There may or may not be direct medical benefits to the participant. Decreased risk of erosion may be a possible benefit if placed in the organic "natural" arm of the study. The information learned from this study may benefit other patients in the future
NCT00271297
Background: The pelvic floor muscles (PFM) are located inside the pelvis, surrounding the urethra, vagina and rectum. They provide structural support for the pelvic organs. Dysfunctional PFM can lead to urine and fecal incontinence, pelvic organ prolapse (POP), sexual problems and chronic pain syndromes. POP increases with age, parity and weakness in the PFM. Symptoms associated with POP are backache, bladder, bowel and sexual dysfunction, and pelvic heaviness. Thus the condition is debilitating and can greatly affect the quality of life, interfering with day-to-day activities and reduce participation in physical activity. The aim of the project: As life expectancy increases, more women may experience POP. Hence it is important to prevent and treat the condition at an early stage. Despite being a common disorder among women, little research has been done on POP. The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT). PFMT is a non-invasive method with no adverse effects. If there is significant effect, the main goal is to incorporate this method in clinical practice among physiotherapists and medical doctors. If PFM training is effective, more emphasis of PFM training can be put into regular female fitness programs. The prevalence of POP increases with age. Method: This is a single blind randomised controlled trial to evaluate the effect of PFMT on POP. 100 women with POP will be randomised to either training or control group. The training programme will last for six months, training once a week with a physiotherapist in addition to a structured home training programme. A blinded case-control study will also be carried out. 50 women without POP will be matched for age and vaginal deliveries. Before starting the RCT study, a reproducibility study on perineal ultrasound will be carried out in 18 women.
NCT00162604
Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections. The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.