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Prolapse Genital clinical trials

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NCT ID: NCT06430931 Recruiting - Clinical trials for Colorectal Disorders

Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery

ProTex
Start date: December 6, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06404931 Not yet recruiting - Prolapse; Female Clinical Trials

Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery. They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone . Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.

NCT ID: NCT05571072 Completed - Opioid Use Clinical Trials

Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the investigators can precisely predict how much pain medication the subjects will need after surgery using a special calculator that was developed for this purpose.

NCT ID: NCT05463081 Completed - Clinical trials for Urinary Incontinence

Clinical Trial of "Magic Gyno" Laser Device

Start date: August 5, 2022
Phase: N/A
Study type: Interventional

The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: gynecology examination, vaginal health index, clinical blood test, vaginal flora examination, vaginal pH. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI) and The Short Form Health Survey (SF-36) will be used to collect feedback on changes in the participants life quality. Total up to 70 participants with pathology of pelvic organs will be involved in the study. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms, by 35 participants in each. The time intervals between tests will be the same for both groups. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the condition before treatment.

NCT ID: NCT04178473 Completed - Prolapse Genital Clinical Trials

Total Versus Subtotal Abdominal Hysterectomy at Time of Abdominal Sacrocolpopexy

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

Uterovaginal prolapse is a common disease. Due to high failure rate that occur following vaginal hysterectomy, sacrocolpopexy is investigated by many resarchers to manage uterovaginal prolapse in non-hystrectomized women. In this study the investigator will compare the result of total versus subtotal hysterectomy at the time of sacrocolpopexy. Study design: Randomized controlled trial Intervention: Group A will have total abdominal hysterectomy Group B will have subtotal abdominal hysterectomy

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: NCT03772015 Completed - Prolapse Genital Clinical Trials

The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension

Start date: December 9, 2018
Phase:
Study type: Observational

Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse. Investigators hypothesized that uterus-preserving lateral suspension provides a better anatomical positioning.

NCT ID: NCT03534830 Completed - Prolapse Genital Clinical Trials

A Novel Assay for Predicting Surgical Outcomes in Pelvic Organ Prolapse

eLASV
Start date: February 2, 2018
Phase:
Study type: Observational

The research objective of this proposal is to investigate the clinical utility and validity of eLASV as a personalized marker for women's individual risk of recurrence for pelvic organ prolapse following advanced surgical procedures. Estimated levator ani subtended volume (eLASV) is a reproducible magnetic resonance image of the female pelvis that objectively quantifies the integrity of the pelvic floor levator ani muscles. A woman's levator ani muscle anatomical shape is unique to her as a result of her own individual lifetime risk for development of pelvic floor dysfunction. The novelty of eLASV as a measurement of muscle integrity, separates it methodology from the solitary of diagnosing partial trauma or defects as previously published within the literature. eLASV measurements have the potential to identify women at increased risk for surgical failure and may be used as a prognostic tool to aid in future counseling and stratification of patients into surgical options for treatment of pelvic organ prolapse.

NCT ID: NCT03200327 Terminated - Prolapse Genital Clinical Trials

Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

SAPPRO
Start date: December 18, 2017
Phase: N/A
Study type: Interventional

The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment

NCT ID: NCT03077490 Completed - Prolapse Genital Clinical Trials

Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device

KIDS
Start date: March 4, 2015
Phase:
Study type: Observational

Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.