Pelvic Organ Prolapse, Stress Incontinence Female
Conditions
Keywords
Stress incontinence, Pelvic organ prolapse, Midurethral sling, Sucess rates, Complication rates, Patient satisfaction
Brief summary
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.
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.
Interventions
PROCEDUREMidurethral 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.
PROCEDUREMidurethral 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative | 3 months | The primary outcome will be change between baseline and 3 months stress urinary incontinence symptoms as measured by the UDI-6. Scores for the UDI-6 range from 0 to 100 has an MCID of 5.8, with higher scores indicating worse symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provocative stress test results at 6 weeks postoperative | 6 weeks | Patients will be examined in the office during 6-week postoperative visit as is routine practice and assess for leakage of urine during empty supine provocative cough stress test. |
| Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative | 6 weeks | If recurrent stress urinary incontinence is noted to be present at 6-weeks postoperative, whether or not patients elect to proceed with additional treatment will be assessed. |
| Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 3 months postoperative | 3 months | PISQ-IR will be administered at enrollment and at 3 months postoperative, and scores will be compared. |
| Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 3 months postoperative | 3 months | IIQ-7 will be administered to patients at enrollment and at 3 months postoperative, and scores at these two time points will be compared. |
| Complications (graded as Clavien Dindo) | 6 weeks | Complications occurring during or after concomitant RSC and RP MUS will be recorded between both groups and compared. |
| Objective surgical data such as operative time | 6 weeks | Objective surgical data such as operative time will be recorded between both groups and compared. |
| Objective surgical data such as estimated blood loss (EBL) | 6 weeks | Objective surgical data such as estimated blood loss (EBL) will be recorded between both groups and compared. |
| Patient satisfaction (a decision scale and decision regret scale) | 3 months | A decision regret scale will be administered to patients at 3 months postoperative, and scores will be compared between the two groups to assess if any difference in patient satisfaction exists. |
| Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence) | 3 months | The PGI-I will be administered to all patients at 3 months to assess patient satisfaction with the procedure performed; any differences between groups in patient satisfaction will be assessed with this outcome. |
Countries
United States
Contacts
CONTACTMartha K Coghlan, MD
CONTACTGabriela E Halder, MD, MPH
PRINCIPAL_INVESTIGATORGabriela E Halder, MD, MPH
University of Alabama at Birmingham
Outcome results
None listed