Clinical Trials Logo
  1. Home
  2. Vaginal Vault Prolapse
  3. NCT02431897

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen — IMPROVE  

Pelvic Organ Prolapse Clinical Trial

Official title:
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

Clinical Trial Summary

This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.

Clinical Trial Description

This is a double-blind randomized trial of intravaginal estrogen (conjugated estrogens, 0.625mg/1g cream) vs. placebo in postmenopausal women (up to n=222 enrolled and randomized in order for 188 to undergo surgery) with symptomatic prolapse beyond the hymen planning transvaginal native tissue repairs. Medication will be started >5 weeks before surgery and continued for 1 year postoperatively, i.e. until scar remodeling is complete. The investigators aim to determine if pre- and postoperative intravaginal estrogen therapy (i) results in anatomic and patient-reported subjective improvement in pelvic organ support, and (ii) impacts other pelvic floor disorders (overactive bladder and incontinence, sexual function and pain, postoperative cystitis), satisfaction, quality of life, and vaginal wound healing. Finally, (iii) the investigators will determine the potential mechanisms by which local estrogen treatment alters pelvic organ support by examining full-thickness vaginal wall biopsies taken at the time of surgery for histologic, connective tissue, and smooth muscle synthesis and degradative changes. The investigators expect this will highlight other novel targets for future therapies in prolapse repair and prevention. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02431897
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase Phase 4
Start date December 2016
Completion date May 17, 2023
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05422209 - The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair. N/A
Active, not recruiting NCT05420831 - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment N/A
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT06126328 - Materna Prep Study Phase II Phase 2
Recruiting NCT05542836 - EVeRLAST 2-Year Follow-Up
Recruiting NCT05918367 - Multicenter Ventral Mesh Rectopexy Registry Collaborative
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Recruiting NCT04807920 - BOTOX® at the Time of Prolapse Surgery for OAB Phase 4
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Recruiting NCT03146195 - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease N/A
Recruiting NCT02919852 - Laparoscopic Retrovesical Colpopectinopexia N/A
Completed NCT02925585 - Vaginal Tactile Imaging for Pelvic Floor Prolapse
Not yet recruiting NCT02536001 - Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes N/A
Recruiting NCT02113969 - Conservative Management of Symptomatic Pelvic Organ Prolapse Using Vaginal Pessaries: Generation of a Standardized Management Protocol N/A
Completed NCT02383199 - Polypropylene Mesh in Prolapse Surgery N/A
Terminated NCT01673360 - Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices N/A
Withdrawn NCT01530191 - Factors Affecting Perioperative Outcomes N/A
Completed NCT01842464 - Sacro-Spinous Ligaments Anterior Apical Anchoring N/A
Completed NCT01320631 - Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction N/A
Completed NCT00581412 - Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates N/A