BOTOX® at the Time of Prolapse Surgery for OAB

Status Recruiting

Clinical Trial Summary

The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.

Clinical Trial Description

After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04807920
Study type	Interventional
Source	Walter Reed National Military Medical Center
Contact	Joy E Wheat, MD
Phone	201-710-5109
Email	joy.e.wheat.mil@mail.mil
Status	Recruiting
Phase	Phase 4
Start date	September 23, 2021
Completion date	June 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05420831` - Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment	N/A
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
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
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
Completed	`NCT01842464` - Sacro-Spinous Ligaments Anterior Apical Anchoring	N/A
Withdrawn	`NCT01530191` - Factors Affecting Perioperative Outcomes	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
Completed	`NCT00551993` - Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse	N/A