Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Midurethral sling placed before robotic sacrocolpopexy
Procedure/SurgerySequence 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.
Midurethral sling placed after robotic sacrocolpopexy
Procedure/SurgerySequence 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Midurethral sling placed before robotic sacrocolpopexyActive comparator 1 intervention
Group B: Midurethral sling placed after robotic sacrocolpopexyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative
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.
Time frame
3 monthsSecondary outcomes
1
Provocative stress test results at 6 weeks postoperative
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.
Time frame
6 weeks2
Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative
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.
Time frame
6 weeks3
Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 3 months postoperative
PISQ-IR will be administered at enrollment and at 3 months postoperative, and scores will be compared.
Time frame
3 months4
Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 3 months postoperative
IIQ-7 will be administered to patients at enrollment and at 3 months postoperative, and scores at these two time points will be compared.
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov