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Prolapse clinical trials

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NCT ID: NCT04087642 Recruiting - Clinical trials for Pelvic Organ Prolapse

CREDE Study: Intraoperative Crede Manoeuver Compared to Preoperative Prolapse Reduction Stress Test to Predict Postoperative de Novo Stress Urinary Incontinence (PONSUI) at the Time of Pelvic Organ Prolapse (POP) Surgery

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI. The rates of PONSUI and its effect on patient reported outcomes and quality of life will be determined among women with positive or negative tests, and those with and without concomitant anti-incontinence procedure performed. This information will help inform larger studies on the topic.

NCT ID: NCT04039009 Recruiting - Clinical trials for Pelvic Organ Prolapse

Apical Pelvic Support in Infertility Patients

Start date: January 1, 2019
Phase:
Study type: Observational

This study aims to evaluate apical pelvic compartment support in infertility patients at the time of hysteroscopy. Apical pelvic compartment evaluation for pelvic organ prolapse will be performed in infertility patients undergoing hysteroscopy.

NCT ID: NCT04025047 Recruiting - Clinical trials for Pelvic Organ Prolapse

A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery

Start date: April 10, 2019
Phase:
Study type: Observational [Patient Registry]

This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).

NCT ID: NCT04010292 Recruiting - Incontinence Clinical Trials

Enhancing Patient Recall in Urogynecologic Surgery

Start date: November 14, 2019
Phase: N/A
Study type: Interventional

Patient counseling is an essential part of any new treatment implementation. This process becomes even more important when it involves surgical counseling. This is when the patient and the surgeon discuss the possible surgical options and ideally establish a plan for the appropriate surgical intervention. Unfortunately, multiple studies have shown that patients tend to have poor recall of the key elements discussed during the consultation (1-3). In the investigators' experience, the concern lies specifically in the level of recall that patients have regarding their planned surgical procedure, as most patients cannot correctly state the planned intervention despite extensive counseling and explanation. Lack of knowledge about the type of surgery can have serious implications for the patient in the future. For example, knowing facts like the presence or absence of the cervix and whether future pap smears are needed or the presence of an implant, such as a mesh are necessary for the patient's well-being and proper medical care down the line, especially when the patient has multiple medical providers. In addition, previous research has demonstrated that low-quality counseling and the feeling of being "unprepared for surgery" directly correlate with patient dissatisfaction (4). This is especially relevant in the field of female pelvic reconstructive surgery, where the success of surgical interventions relies heavily upon subjective patient-reported outcomes (5). There have been many studies to augment the counseling process using supplemental materials. These have included use of multiple visual charts, anatomical models, and passive and interactive audiovisual aids (6). Some improvement in the outcomes has been observed in various fields of medicine with the dissemination of supplemental patient resources (7-10). However, in urogynecology, the effectiveness of surgical counseling sessions has not been achieved despite the different additional methods for patient education (6, 11). Reasons that urogynecologic supplemental materials have not seen the same level of success as those in other fields of medicine include the complexity of the surgeries and the language used in many of these educational aids (12). The investigators aim to address the problem of poor patient recall of their procedure by providing them with an easy-to-read patient card detailing the anticipated surgery at the time of their consult.

NCT ID: NCT04010162 Recruiting - Clinical trials for Urinary Incontinence

Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study.

Mesh_Survey
Start date: March 1, 2019
Phase:
Study type: Observational

This study evaluates the awareness of mesh discussions in urogynecology among non-urogynecologists. A web-based questionnaire will be sent to four groups. Group-1 is King's College Hospital doctors. Group-2 is Uludag University Hospital doctors. Group-3 is doctors from the United States, and Group-4 is doctors from all over the world.

NCT ID: NCT04009694 Recruiting - Clinical trials for Pelvic Organ Prolapse

Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03973281 Recruiting - Clinical trials for Pelvic Organ Prolapse

EASE: The Materna Prep Pivotal Study

Start date: December 11, 2019
Phase: N/A
Study type: Interventional

This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.

NCT ID: NCT03962023 Recruiting - Clinical trials for Mitral Valve Insufficiency

Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)

COHORTE-IM
Start date: September 4, 2019
Phase:
Study type: Observational [Patient Registry]

Degenerative mitral insufficiency secondary to valve prolapse is the most common valve disease in Western countries. In the absence of specific treatment, it spontaneously progresses to heart failure and death when it is severe. Surgical mitral valve repair (or mitral plastic surgery) is the preferred treatment for primary mitral insufficiency by prolapse in case of severe leakage if associated with clinical and/or echocardiographic markers of poor prognosis (i.e., with high risk of morbi-mortality during their follow-up). It is therefore essential to refine the risk stratification of these patients in order to identify at-risk patients who should potentially benefit earlier from invasive care (cardiac surgery), or conversely, close monitoring. A number of echocardiographic and MRI parameters may have been associated with a poorer prognosis. A cohort of patients with primary mitral insufficiency (MI) will be followed to study the relationships of a set of factors to patient prognosis.

NCT ID: NCT03947164 Recruiting - Prolapse Genital Clinical Trials

iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Between Patients With Urogenital Prolapse and Those Who Are Asymptomatic

iMEA
Start date: July 17, 2019
Phase: N/A
Study type: Interventional

Pelvic organ prolapse (POP) is defined by the International Continence Society (ICS) as a downward displacement of one or several of the followings: "the anterior wall of the vagina", "the posterior wall of the vagina" or "the cervix". Principal risk factor of the POP is the muscular trauma of the Levator Ani Muscle (LAM) or pelvic nerve injury during vaginal delivery and pregnancy. The POP is a real public health problem. Nearly a quarter of the female population will be affected by this pathology during their lifetime. Also, the POP is responsible for impaired quality of life. POP management is mainly surgical. The LAM is classically described as a striated muscle. In an anatomic study based on female human fetuses, it has been described a new representation of nerve supplying LAM innervation with both autonomic and somatic participation. In a second study, it has been observed within the LAM, a visceral medial area (interface with the pelvic viscera) composed of smooth muscle cells under autonomic nervous control and a lateral parietal area (interface with the bone basin) composed of striated muscle cells under somatic control. Because of the medial localization of these smooth muscle areas, it is hypothesed that the visceral medial zone within the LAM plays a major role in pelvic status maintaining. The main goal is to compare the proportion of smooth muscle cells within the MEA in patients with urogenital prolapse and in asymptomatic ones. The secondary objectives are: - To compare the expression of neurotransmitters within smooth muscle cell areas in patients with POPs and asymptomatic patients. - To compare the proportion of striated muscle cells in MEA in patients with POPs and asymptomatic patients.

NCT ID: NCT03919123 Recruiting - Quality of Life Clinical Trials

Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).

PeSuLife
Start date: January 1, 2019
Phase:
Study type: Observational

Prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. Its prevalence tends to increase due to increased life expectancy and obesity. The main treatment is surgical and involves all organ specialists dealing with pelvic-perineal functional disorders: urologists, gynecologists, digestive surgeons. Our team wishes to evaluate, on a cohort of patients operated at the Caen University Hospital, the functional uro-gynecologic, digestive and sexual results of pelvic organ prolapse (POP) repair by Laparoscopic Promontofixation (PFL) through symptoms and quality of life validated questionnaires (QoL). The analysis of the responses to these questionnaires will allow us to evaluate the functional results in the short and medium term (from 6 months to 5 years)