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Uterine Prolapse clinical trials

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NCT ID: NCT05355623 Completed - Clinical trials for Vaginal Wall Prolapse

Surgical Repair of Vaginal Wall Prolapse Using Gamma Irradiated Amniotic Membrane as a Scaffold

Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %. This high recurrence rate creates the necessity for developing new surgical techniques and better long-term solutions. Surgeons have been investigating the use of synthetic and biological grafts in vaginal wall prolapse repairs

NCT ID: NCT05335317 Recruiting - Vaginal Atrophy Clinical Trials

Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.

NCT ID: NCT05252637 Completed - Clinical trials for Pelvic Organ Prolapse

Laparoscopic Fascial Duplication Plus Sacral Colpopexy in Posterior Vaginal Prolapse

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

A Randomized Clinical Trial on Laparoscopic Fascial posterior vaginal duplication with absorbable sutures plus sacral colpopexy mesh placement VS sacral colpopexy isolated for vaginal posterior prolapse

NCT ID: NCT05063331 Recruiting - Uterine Prolapse Clinical Trials

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

PREMIER
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.

NCT ID: NCT04882995 Completed - Constipation Clinical Trials

Effect of Preoperative Fiber on Postoperative Bowel Function

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation. The investigators are conducting this study to determine if participants who receive psyllium fiber before surgery have less difficulty with their first bowel movement after surgery.

NCT ID: NCT04817150 Recruiting - Rectal Prolapse Clinical Trials

3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

LARC
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse. This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q [pelvic organ prolapse quantification] grade) and/or full-thickness rectal prolapse. Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed. The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.

NCT ID: NCT04701047 Recruiting - Vaginal Prolapse Clinical Trials

Prospective Observational Prolapse Study

Start date: September 3, 2021
Phase:
Study type: Observational [Patient Registry]

The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

NCT ID: NCT04637022 Recruiting - Uterine Fibroid Clinical Trials

4K Versus 3D Laparoscopic Colporraphy by Surgeons in Training: a Prospective Randomized Trial

Start date: January 25, 2021
Phase:
Study type: Observational

This prospective randomized trial aims to assess if the operative time of vaginal cuff suture performed by trainees could be reduced using 3D laparoscopy instead of 4K laparoscopy.

NCT ID: NCT04478747 Recruiting - Clinical trials for Prolapse, Vaginal Vault

Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study

TVM vs LCSP
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane. The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.

NCT ID: NCT04440475 Recruiting - Pain, Postoperative Clinical Trials

Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy

SACROTAP
Start date: June 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether the transversus abdominis plane block (Tap block) is different than the oral postoperative pain medications in controlling pain after robotic sacrocolpopexy.