Clinical trials: Genital Prolapse
Pelvic Organ Prolapse (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
- Conditions
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Urinary Incontinence,Stress, Stress Urinary Incontinence
Synchronized Core-Pelvic Floor Activation in Urinary Incontinence
This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence.
- Conditions
- Urinary Incontinence,Stress, Stress Urinary Incontinence, Mixed Incontinence Due to Prolapse of Female Genital Organ, Urinary Incontinence
- Trial name
- NCT07387640
- Testing
- Conventional Pelvic Floor Muscle Training, Pelvic Floor and Core Muscle Co-activation Training
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Bezmialem Vakif University
Postoperative Care, Prolapse Genital
Postoperative Vaginal Compression After Prolapse Surgery - an RCT
The goal of this clinical trial is to learn if omitting postoperative vaginal compression (packing) can facilitate a more efficient recovery after elective surgery for uterovaginal prolapse.
- Conditions
- Postoperative Care, Prolapse Genital, Urogynecologic Surgery
- Trial name
- NCT07612202
- Testing
- No postoperative vaginal compression, Postoperative vaginal compression
- Where
- Denmark
- Volunteers
- 360 people
- Sponsor
- Christiane Marie Bourgin Folke Gam
Pelvic Organ Prolapse, Genital Prolapse
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
- Trial name
- i-StitchSSLF (NCT06805006)
- Testing
- SSLF
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Prolapse Genital, Prolapse Uterovaginal
Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system.
- Conditions
- Prolapse Genital, Prolapse Uterovaginal, Prolapse; Female
- Trial name
- FIMEA (NCT07194343)
- Testing
- Laparoscopic colposacropexy with levator ani muscle mesh fixation, Simplified modification of laparoscopic colposacropexy
- Where
- 6 sites in Spain
- Volunteers
- 190 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Genital Prolapse
Laparoscopic Pectopexy With and Without Mesh Use for Pelvic Organ Prolapse.
Genital apical prolapse refers to the descent of the vaginal apex, uterus, or cervix, and surgical treatment is required for adequate apical support.
- Trial name
- NCT07306715
- Testing
- Meshless Laparoscopic Pectopexy, Laparoscopic Pectopexy with mesh
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Kocaeli University
Genital Prolapse
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care.
- Trial name
- REPAIR (NCT06296316)
- Testing
- Restorelle Polypropylene Mesh
- Where
- 6 sites in France
- Volunteers
- 39 people
- Sponsor
- Coloplast A/S
Colorectal Disorders, Prolapse
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
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.
- Conditions
- Colorectal Disorders, Prolapse, Prolapse Rectal, Prolapse Genital
- Trial name
- ProTex (NCT06430931)
- Testing
- Minimal invasive abdominal prolapse surgery using Polypropylene mesh, Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh
- Where
- Netherlands
- Volunteers
- 184 people
- Sponsor
- Meander Medical Center
Medial and/or Anterior Genital Prolapse
Efficacy of IFABONDTM Synthetic Glue for Fixation of Implanted Material in Laparoscopic Sacrocolpopexy: a Prospective Multicenter Study
Laparoscopic sacrocolpopexy is the consensual attitude of choice in genital prolapse but incurs problems of tolerance of implanted material.
- Trial name
- PRO-COLLE (NCT02011373)
- Testing
- fixation technique using a sterile synthetic liquid tissue glue: IFABOND™
- Where
- 3 sites in France
- Volunteers
- 70 people
- Sponsor
- Hospices Civils de Lyon
Prolapse Genital
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
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…
- Trial name
- SAPPRO (NCT03200327)
- Testing
- promontofixation, sacrospinofixation
- Where
- 6 sites in France
- Volunteers
- 55 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Genital Prolapse, Unspecified
Comparison of the Effects of Sacrospinous Fixation and V-notes Lateral Suspension Operations
Comparison of the effects of sacrospinous fixation and v-notes lateral suspension operations on anatomical recovery, effectiveness and quality of life in a training and research hospital gynecology and obstetrics clinic.
- Trial name
- NCT06307873
- Testing
- pre and post operative POP-Q results, pre and post operative PİSQ-12 results
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Gaziosmanpasa Research and Education Hospital
Prolapse Genital, Vulvovaginal Disease
Randomized Study Evaluating the Treatment of Vulvovaginal Gaping by Plication of the Puborectalis Muscles Versus Perineorrhaphy ± Transverse Myorrhaphy of the Puborectalis Muscles at 12 Months. (HERA)
Vulvovaginal incompetence is generally associated with prolapse and contributes to the pathogenesis of the latter. The perineum and the perineal body (PB) are structures frequently injured throughout life, leading to…
- Trial name
- HERA (NCT07245823)
- Testing
- Anatomical reconstruction of the vulvovaginal gape, Questionnaires, MRI
- Where
- France
- Volunteers
- 100 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Genital Prolapse, Vaginal Floor Prolapse
Ambulatory Prolapse Surgery
Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction.
- Trial name
- PROLAMBU (NCT02585544)
- Testing
- day-care surgery
- Where
- France
- Volunteers
- 38 people
- Sponsor
- Hospices Civils de Lyon
Prolapse Genital
iMEA : Comparison of Micro-innervation and Muscle Microstructure of the Anal Levator Muscle Between Patients With Urogenital Prolapse and Those Who Are Asymptomatic
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…
- Trial name
- iMEA (NCT03947164)
- Testing
- biopsy
- Where
- France
- Volunteers
- 21 people
- Sponsor
- Rennes University Hospital
Prolapse; Female, Prolapse Genital
Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
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.
- Conditions
- Prolapse; Female, Prolapse Genital, Prolapse Uterovaginal
- Trial name
- NCT06404931
- Testing
- Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device, Vaginal hysterectomy plus anterior colporrhaphy, Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
- Where
- Spain
- Volunteers
- 90 people
- Sponsor
- Hospital Mutua de Terrassa
Female Urogenital Diseases, Urinary Incontinence
Clinical Trial of "Magic Gyno" Laser Device
The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose.
- Conditions
- Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital, Menopausal Syndrome
- Trial name
- NCT05463081
- Testing
- Laser treatment, Blood test, Clinical urine test
- Where
- Russia
- Volunteers
- 70 people
- Sponsor
- MeLSyTech, Ltd
Female Genital Prolapse
Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse
This study aims to determine the rate of recurrence of central pelvic organ prolapse in patients who have undergone surgery (sacropexy with and without mesh) for the same pathology.
- Trial name
- NCT06720831
- Where
- 2 sites in Italy
- Volunteers
- 160 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Genital Prolapse, Pessary
Pessary Satisfaction Criteria for Urogenital Prolapse
Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used.
- Conditions
- Genital Prolapse, Pessary, Satisfaction
- Trial name
- PeSaCUP (NCT03615872)
- Testing
- pessary use
- Where
- France
- Volunteers
- 150 people
- Sponsor
- University Hospital, Caen
Post Operative Pain, Opioid Use
Opioid Use After Urogynecologic Procedures: Using a Predictive Calculator
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.
- Conditions
- Post Operative Pain, Opioid Use, Prolapse Genital
- Trial name
- NCT05571072
- Testing
- Opioid calculator, Standard opioid prescription
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- David Sheyn
Thymoma, Mediastinal Tumor
Clinical Investigation of the da Vinci Surgical System
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
- Conditions
- Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer
- Trial name
- NCT05682742
- Testing
- Robotic-assisted Surgery
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Intuitive Surgical