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Purpose

This study looks at the best time to place a midurethral sling (MUS), which is a small piece of mesh used to treat stress urinary incontinence (SUI) (leaking urine when you cough, laugh, or exercise). The sling is placed during a type of surgery called robotic sacrocolpopexy (RSC). This surgery helps fix pelvic organ prolapse, when organs like the bladder or uterus drop from their normal place. Doctors can place the sling either before or after they lift and support the top of the vagina during surgery, but they aren't sure which timing works better. In this study, investigators are comparing what is the best time to place the sling, how the patient feels after surgery and if a patient's symptoms got better or worse.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least 18 years of age - Able to speak and read English and Spanish - Diagnosis of pelvic organ prolapse stage 2-4 - Planning to undergo a robotic-assisted sacrocolpopexy - Demonstrable SUI (either by CST, with or without prolapse reduction, or UDS) within the year prior to enrollment - Planning to undergo concomitant SUI correction with MUS at the time of RSC

Exclusion Criteria

  • Less than 18 years of age - Unable to speak and read English or Spanish - No diagnosis of SUI (prophylactic slings) - History of prior surgery for SUI - Bladder capacity <200 mL or post-void residual (PVR) >150 mL - Current genitourinary fistula or urethral diverticulum

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Midurethral sling placed before robotic sacrocolpopexy 		Midurethral sling placed after robotic sacrocolpopexy
  • Procedure: Midurethral sling placed before robotic sacrocolpopexy
    Sequence of midurethral sling placement (before or after suspension of the vaginal apex) during robotic sacrocolpopexy is largely surgeon-dependent and dictated by training and experience. This study will examine whether there are any differences in continence and patient satisfaction between patients in whom slings are placed prior to suspension of the vaginal apex during robotic sacrocolpopexy versus after.
Active Comparator
Midurethral sling placed after robotic sacrocolpopexy
  • Procedure: Midurethral sling placed after robotic sacrocolpopexy
    Sequence of midurethral sling placement (before or after suspension of the vaginal apex) during robotic sacrocolpopexy is largely surgeon-dependent and dictated by training and experience. This study will examine whether there are any differences in continence and patient satisfaction between patients in whom slings are placed prior to suspension of the vaginal apex during robotic sacrocolpopexy versus after.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Martha K Coghlan, MD
205-934-1777
mkcoghlan@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Martha K Coghlan, MD
6019883613
mkcoghlan@uabmc.edu

Detailed Description

Investigators will conduct a prospective, randomized, noninferiority trial on patients undergoing retropubic midurethral sling (RP MUS) placement at the time of robotic-assisted sacrocolpopexy (RSC). Patients scheduled to undergo retropubic midurethral sling placement at the time of robotic- assisted sacrocolpopexy will be invited to participate during regularly scheduled preoperative visits with their urogynecologic provider. Participants will be randomized to receive RP MUS before RSC or after RSC. Randomization will be conducted in RedCap. Randomization will be performed using a variable permutated block randomization scheme. The Randomization window will be +/- 4 days before their scheduled surgery, and patients will be blinded to sequence of MUS placement intraoperatively.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.