Clinical trials: Pelvic Organ Prolapse (POP), active
Pelvic Floor Dysfunction, Perineal Laceration
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in…
- Conditions
- Pelvic Floor Dysfunction, Perineal Laceration, Wound Dehiscence, Anal Incontinence
- Trial name
- PeriPROTECT (NCT07862660)
- Testing
- Perineal protection device, BabySlide, Standard manual perineal support
- Where
- Sweden
- Volunteers
- 4,226 people
- Sponsor
- Region Skane
Pelvic Organ Prolapse (POP), Postoperative Pain
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
The goal of this clinical trial is to determine whether suzetrigine, when added to standardized multimodal postoperative analgesia improves pain control and reduces opioid consumption after apical suspension surgery for pelvic…
- Conditions
- Pelvic Organ Prolapse (POP), Postoperative Pain, Urogynecology
- Trial name
- SUSI (NCT07856654)
- Testing
- Suzetrigine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Aditi Talkad
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress
A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic organ prolapse in women is a common gynecological condition worldwide, with prevalence reported by different authors ranging from 15% to 50%.
- Conditions
- Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress, Urinary Incontinence (UI), Female Sexual Dysfunction (FSD)
- Trial name
- NCT07271862
- Testing
- Laparoscopic sacrocolpopexy., Laparoscopic apical promontofixation combined with simultaneous vaginal and perineal reconstruction using native tissues.
- Where
- Latvia
- Volunteers
- 60 people
- Sponsor
- Riga East Clinical University Hospital
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative…
- Conditions
- Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI), Postoperative Pain
- Trial name
- NCT07600697
- Testing
- Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone), Scheduled Acetaminophen and Ibuprofen
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of California, Los Angeles
Pelvic Organ Prolapse (POP), Cystocele
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
Pelvic organ prolapse (POP) is a condition characterized by descent of vaginal walls, uterus and cervix, or the perineum and causes a sensation of vaginal bulge and pelvic pressure.
- Conditions
- Pelvic Organ Prolapse (POP), Cystocele, Pelvic Floor Disorder
- Trial name
- NCT07544667
- Testing
- Poly-L-Lactic Acid (Sculptra) injection
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cassandra Kisby
Pelvic Organ Prolapse (POP)
Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery.
- Trial name
- VEPO (NCT07030426)
- Testing
- Vaginal Estrogen - Twice Weekly, Vaginal Estrogen - Daily
- Where
- 2 sites in Canada
- Volunteers
- 180 people
- Sponsor
- Sarah Wozney
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
Rectal Prolapse, Pelvic Organ Prolapse (POP)
RECTOSACROUTEROPEXY vs. WELLS
The goal of this clinical trial was to compare two surgical techniques in female patients with full-thickness rectal prolapse. The main questions it aimed to answer were: 1.
- Trial name
- RSUP (NCT07673406)
- Testing
- Modified rectosacrouteropexy, Wells rectopexy
- Where
- Azerbaijan
- Volunteers
- 36 people
- Sponsor
- Azerbaijan Medical University
Pelvic Organ Prolapse (POP)
Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse
Pelvic organ prolapse (POP) is a common health issue. It will impact about half of Canadian women over their lifetime. With POP, organs like the bladder, uterus, and bowel may push into the vagina.
- Trial name
- NPP-POP (NCT06954701)
- Testing
- Novel Personalizable Pessary
- Where
- Canada
- Volunteers
- 43 people
- Sponsor
- University of Alberta
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
Urinary Continence After Vaginal Surgery for Genital Prolapse in the Spanish Population.
Surgical correction of pelvic organ prolapse (POP) may be associated with the development of postoperative stress urinary incontinence (SUI).
- Conditions
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Urinary Incontinence (UI)
- Trial name
- NCT07628036
- Testing
- Vaginal surgery for pelvic organ prolapse
- Where
- 4 sites in Spain
- Volunteers
- 1,042 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Urinary Incontinence, Pelvic Organ Prolapse (POP)
The RECOVER Study - Postpartum Recovery of Pelvic Floor Structures and the Impact of Early Rehabilitation
The goal of this observational study with an embedded pilot clinical trial is to learn how the pelvic floor recovers after vaginal childbirth and whether early individualized pelvic floor muscle training can improve recovery in…
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse (POP), Bowel Symptoms, Postpartum
- Trial name
- RECOVER (NCT07430865)
- Testing
- Early individualized pelvic floor muscle training (PFMT)
- Where
- 2 sites in Sweden
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Vastra Gotaland Region
Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI)
Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery
This observational study aims to develop a predictive model for the occurrence of new-onset stress urinary incontinence (SUI) after pelvic organ prolapse (POP) repair surgery in women.
- Trial name
- NCT07601282
- Testing
- Telephone follow-up
- Where
- China
- Volunteers
- 382 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Uterine Prolapse, Pelvic Organ Prolapse Vaginal Surgery
The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
The goal of this clinical trial is to compare the Manchester procedure and vaginal hysterectomy in treating patients with symptomatic uterine prolapse.
- Conditions
- Uterine Prolapse, Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse (POP)
- Trial name
- Fin-UP (NCT07566949)
- Testing
- Manchester procedure, Vaginal hysterectomy
- Where
- 6 sites in Finland
- Volunteers
- 426 people
- Sponsor
- Tampere University Hospital
Pelvic Organ Prolapse, Pelvic Organ Prolapse (POP)
Accelerometer Measured Early Recovery After Prolapse Surgery
The AccelERate study will evaluate the physical recovery of patients who have undergone Pelvic Organ Prolapse (POP) surgery. This will be evaluated via a self-reported recovery questionnaire completed daily.
- Conditions
- Pelvic Organ Prolapse, Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse, Patient Education
- Trial name
- AccelERate (NCT07218016)
- Testing
- Postoperative Exercise regimen
- Where
- 7 sites in United States
- Volunteers
- 288 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Pelvic Organ Prolapse (POP), Postoperative Pain
Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic…
- Trial name
- vNOTES-PB (NCT07440576)
- Testing
- Bupivacaine, Normal Saline
- Where
- Turkey (Türkiye)
- Volunteers
- 58 people
- Sponsor
- Erkan Gol
Pelvic Organ Prolapse (POP)
Efficacy and Safety of Laparoscopic Lateral Suspension and Transvaginal Sacrospinous Ligament Fixation in Patients With Pelvic Organ Prolapse
This study is a single-center, non-blinded, non-inferiority randomized controlled trial, planning to recruit 86 patients with Stage III or higher pelvic organ prolapse who are unresponsive to conservative treatment and are…
- Trial name
- NCT06903988
- Testing
- laparoscopic lateral suspension, Transvaginal sacrospinous ligament fixation
- Where
- China
- Volunteers
- 86 people
- Sponsor
- Peking University People's Hospital
Pelvic Organ Prolapse (POP)
Are There Benefits of Using Energy-based Devices for Opportunistic Salpingo-oophorectomy During Vaginal Hysterectomy Compared to a Standard Cold Approach?
This study compares two methods for removing the fallopian tubes and ovaries during vaginal hysterectomy for pelvic organ prolapse.
- Trial name
- NCT07379411
- Testing
- LigaSure MaryLand, Standard salpingo-oophorectomy technique
- Where
- Israel
- Volunteers
- 70 people
- Sponsor
- Wolfson Medical Center
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
The goal of this study is to compare vaginal mesh surgery with abdominal robotic-assisted mesh surgery for the treatment of genital prolapse in women.
- Conditions
- Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery, Mesh Reinforcement, Vaginal Apex/Uterine Prolapse
- Trial name
- NCT07359755
- Testing
- Vaginal mesh surgery for apical prolapse, Robotic-assisted abdominal mesh surgery with Upsylon device (Boston Scientific - USA) for vaginal apical prolapse
- Where
- Brazil
- Volunteers
- 86 people
- Sponsor
- University of Sao Paulo General Hospital
Uterine Fibroids (UF), Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
POPQ Associated With Total Laparoscopic Hysterectomy
The goal of this observational study is to evaluate the impact of different hysterectomy (removal of the uterus) techniques on the risk of pelvic organ prolapse (situation when one or more of your pelvic organs like your bladder…
- Conditions
- Uterine Fibroids (UF), Abnormal Uterine Bleeding Unrelated to Menstrual Cycle, Endometrial Hyperplasia, Pelvic Organ Prolapse (POP)
- Trial name
- POP-LAP (NCT07137299)
- Testing
- Questionnaire and Physical Exam
- Where
- 4 sites in Poland
- Volunteers
- 2,000 people
- Sponsor
- Medical University of Silesia