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NCT07295782
Determination of fibrin clot properties along with thrombin generation in women after urigynecological surgery.
NCT07094815
This study aims to compare the effectiveness of laparoscopic lateral suspension (LLS) with and without hysterectomy in the treatment of pelvic organ prolapse. Pelvic organ prolapse is a condition that affects many women and can significantly reduce quality of life. Laparoscopic lateral suspension is a minimally invasive surgical technique used to correct this condition. In some cases, the uterus is preserved, while in others, hysterectomy is performed at the same time. The study retrospectively evaluates patients who underwent laparoscopic lateral suspension, either with or without hysterectomy, at SBÜ Gaziosmanpaşa Training and Research Hospital. Medical records were reviewed to collect information about surgery duration, anatomical success (measured by the POP-Q system), complication rates, blood loss, hospital stay, and recurrence rates. The goal of this study is to determine whether performing a hysterectomy during laparoscopic lateral suspension has a significant effect on surgical outcomes. The findings may help guide surgical decision-making and improve treatment strategies for women with pelvic organ prolapse.
NCT07080203
Study design: The study building by two design a descriptive exploratory research design and quasi experimental research design were utilized in the present study Setting of the study: This study was conducted at the Outpatient Clinics of Sohag university hospital after approval from the Sohag university medical ethics committee and nursing ethics committee. Subjects of the study Sampling: the sample consists of 400 women. Sample technique: a convenient sample of all available women attending outpatient clinics at sohag university hospital and according to the pilot study and demand of the women to clinical investigations also authenticity for the P-QOL. Questionnaire the Quasi experimental research design with purposive sample from the convenient sample were used to confirm the diagnosis and make intervention to improve the quality of life for that women . Tools of study: Two tools were utilized and filled by researchers for collecting the data of this study. The First Tool: Structured interviewing questionnaire developed by the researcher based on relevant literature divided into three parts. Part I: socio demographic data as; (age, level of education , income , marital status , place of residence, occupation,). Part II: Medical history: Related to chronic constipation ,chronic cough and other chronic diseases. Part III: obstetrical history: Includes (number of pregnancies, number of vaginal deliveries, inter pregnancy interval) The second Tool: P-QOL. questionnaire adopted from (Digesu et al., 2005) and consist of 9 items (General health perceptions, Prolapse impact, Role limitations, Physical limitations, Social limitations, Personal relationships, Emotions, sleep /energy , Severity measures) then after detect and to determine the degree of prolapse were referred to gynecological clinic to be investigated by clinical supervisor. Scoring system: The researcher collected data from patients to complete the P-QOL questionnaire to assess how much their symptoms (if present) were affecting them. Responses ranged from ''not at all, through ''slightly'', ''moderately'' to ''a lot'', from very good to very poor and never to all the time. Therefore, a four- or five-point scoring system according each item was used for severity measurement of uterine prolapse symptoms. Scores in each domain range between 0 and 100. A high total score indicates a greater impairment of quality of life, while a low total score indicates a good quality of life. * A score from 0 to 50 indicates women has good quality of life with no symptoms of uterine prolapse * A score more than 50 indicates women has impairment of quality of life and need to clinical evaluation to confirm the degree with symptoms of uterine prolapse. Tool Validity and Reliability: Validity: The validity was assessed by measuring levels of missing data, comparing symptom scores between affected and asymptomatic women and lastly comparing symptom scores with objective vaginal examination related to stages of uterine prolapse, in the symptomatic group, as described in the POP-Q, using Spearman's correlation coefficient (construct validity). (Digesu et al., 2005). Reliability: The reliability of the questionnaire was assessed by its internal consistency using the Cronbach alpha and stability using a 2-week test-retest analysis. Internal consistency refers to the degree of correlation between the items. Therefore, it is expected that items forming a domain should moderately correlate with each other, but should contribute independently to the overall domain score. A perfect correlation of 1.0 indicates that the questions are measuring an identical construct. A poor correlation instead suggests that the items are testing different traits. A Cronbach alpha of \>0.7 has been recommended as acceptable. (Digesu et al., 2005). Pilot study: It was carried out on 40 women to understand the feasibility of participant recruitment regarding study design and to ensure that the respondents for the pilot should be as similar as possible for the actual items in terms of age, gender, education, socioeconomic (income) status. It also helped in the estimation of the time needed to fill the tool .Women who participated in pilot study were included in the main study because because no modifications needed to be performed and five cases of them have uterine prolapse symptoms need clinical examination.
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.
NCT03095716
The primary purpose is to evaluate the quality of post-operative recovery and post-operative pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine prolapse.
NCT01766193
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. Previous studies have shown that pregnancy and childbirth are risk factors for developing prolapse. There is a lack of studies that follow women several years after delivery aiming to find whether symptoms of prolapse are linked to delivery method, ie vacuum, forceps, normal vaginal delivery and cesarean section. The investigators plan this study is to get more knowledge about pathology of prolapse and incontinence, to enable development of preventive strategies for these conditions. Aim of the study is to determine whether the prevalence of symptoms and performed surgery for urogenital prolapse differs among women delivered by vacuum, forceps, normal vaginal delivery and cesarean section 15-20 years after their first delivery. The investigators identify women that delivered their first child at St. Olavs Hospital, Trondheim, Norway between 1990-1997. Questionnaires will be sent to 2500 women (PFIQ-7, PFDI-20, PISQ-12), 600 of whom will get a clinical examination, where pelvic floor musculature is examined by palpation and 4D ultrasound, and a POP-Q quantification of prolapse performed.
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