Foley Catheterization Following Sacrocolpopexy

Status Withdrawn

Clinical Trial Summary

The objective of this study is to prospectively evaluate the effects of early versus delayed removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim is to determine the optimal time of removal of an indwelling transurethral catheter postoperatively in an effort to reduce the risk of postoperative urinary retention and urinary tract infection associated with catheter use. The investigators hypotheses are as follows:

Hypothesis 1: Longer duration of postoperative catheter use will result in decreased postoperative urinary retention.

Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence of urinary tract infection.

Clinical Trial Description

Patients scheduled to undergo sacrocolpopexy for pelvic organ prolapse at the University of Oklahoma Health Sciences Center will be recruited for this study. Written informed consent will be obtained from all participants prior to the scheduled surgery and before the randomization process. This study will contain two arms, each with two groups. The first arm will have participants receiving sacrocolpopexy for pelvic organ prolapse; the second arm will consist of participants receiving sacrocolpopexy plus a concomitant procedure for stress urinary incontinence. Each participant will be assigned to the arm that matches their scheduled procedure; they will then be randomized into one of the two study groups within that arm. Randomization will be performed by placing note cards in sealed envelopes with "Group A" or "Group B" listed on the card. One envelope will be placed with each participant's preoperative packet and opened on the day of surgery after the operation is complete.On the date of the procedure, a urinalysis will be performed prior to the routine administration of prophylactic antibiotics. At the beginning of the procedure, a transurethral catheter will be placed as is routine for this procedure. At the conclusion of the procedure, the sealed envelope containing the participant's group designation will be opened and she will be assigned to one of two groups. Group A participants will have their catheter removed on postoperative day 1 and Group B will have their catheter removed on postoperative day 2. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01525498
Study type	Observational
Source	University of Oklahoma
Contact
Status	Withdrawn
Phase	N/A
Start date	August 2011
Completion date	April 2013

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
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	`NCT02919852` - Laparoscopic Retrovesical Colpopectinopexia	N/A
Recruiting	`NCT03146195` - The 3D Reconstruction Research of Pelvic Organ Prolapse Disease	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.