Stress Incontinence FemaleNCT07008898
Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
A study testing Midurethral sling placed before robotic sacrocolpopexy and Midurethral sling placed after robotic sacrocolpopexy in people with Stress Incontinence Female and Pelvic Organ Prolapse, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Incontinence Female, Pelvic Organ Prolapse
- What is being tested?
- Midurethral sling placed before robotic sacrocolpopexy and Midurethral sling placed after robotic sacrocolpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Karissa Leong Fellow, MD, 518-262-5013, leongk9@amc.edu
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Martha K Coghlan, MD, 205-934-1777, mkcoghlan@uabmc.edu
Gabriela E Halder, MD, MPH, 205-975-0304, gehalder@uabmc.edu
About this study
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.
Read the 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.
- Conditions
- Stress Incontinence Female, Pelvic Organ Prolapse
- Being tested
- Midurethral sling placed before robotic sacrocolpopexy, Midurethral sling placed after robotic sacrocolpopexy
- Keywords
- Stress incontinence, Pelvic organ prolapse, Midurethral sling, Sucess rates, Complication rates, Patient satisfaction
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midurethral sling placed before robotic sacrocolpopexyProcedure or surgery
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.
Midurethral sling placed after robotic sacrocolpopexyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Midurethral sling placed before robotic sacrocolpopexy | Active comparator | Midurethral sling placed after robotic sacrocolpopexy Receives: Procedure: Midurethral sling placed before robotic sacrocolpopexy |
| Midurethral sling placed after robotic sacrocolpopexy | Active comparator | Not described Receives: Procedure: Midurethral sling placed after robotic sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (9)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 3 months
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.
Measured: 3 months
Complications (graded as Clavien Dindo)
Complications occurring during or after concomitant RSC and RP MUS will be recorded between both groups and compared.
Measured: 6 weeks
Objective surgical data such as operative time
Objective surgical data such as operative time will be recorded between both groups and compared.
Measured: 6 weeks
Objective surgical data such as estimated blood loss (EBL)
Objective surgical data such as estimated blood loss (EBL) will be recorded between both groups and compared.
Measured: 6 weeks
Patient satisfaction (a decision scale and decision regret scale)
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.
Measured: 3 months
Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start8 Jul 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Incontinence FemaleStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Halder, University of Alabama at Birmingham
- Investigators
- Gabriela E Halder, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008898
- Sponsor's protocol ID
- 300014707
- Other IDs
- No funding
- Status last verified
- Feb 2026
- First submitted
- 27 May 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Minimum necessay IPD will be shared with other researchers if trial is expanded to multiple sites.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
- ClinicalTrials.gov ID
- NCT07008898
- Acronym / sponsor ID
- 300014707
- Conditions
- Stress Incontinence Female, Pelvic Organ Prolapse
- Keywords
- Stress incontinence, Pelvic organ prolapse, Midurethral sling, Sucess rates, Complication rates, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midurethral sling placed before robotic sacrocolpopexy | Active comparator | Procedure: Midurethral sling placed before robotic sacrocolpopexyMidurethral sling placed after robotic sacrocolpopexy |
| Midurethral sling placed after robotic sacrocolpopexy | Active comparator | Procedure: Midurethral sling placed after robotic sacrocolpopexy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Able to speak and read English and Spanish
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midurethral sling placed before robotic sacrocolpopexySequence 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. | Procedure or surgery | Midurethral sling placed before robotic sacrocolpopexy |
| Midurethral sling placed after robotic sacrocolpopexySequence 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. | Procedure or surgery | Midurethral sling placed after robotic sacrocolpopexy |
Primary outcome
Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative
Time frame: 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.
9 secondary outcomes
Provocative stress test results at 6 weeks postoperative
Time frame: 6 weeks
Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative
Time frame: 6 weeks
Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 3 months postoperative
Time frame: 3 months
Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 3 months postoperative
Time frame: 3 months
Complications (graded as Clavien Dindo)
Time frame: 6 weeks
Objective surgical data such as operative time
Time frame: 6 weeks
Objective surgical data such as estimated blood loss (EBL)
Time frame: 6 weeks
Patient satisfaction (a decision scale and decision regret scale)
Time frame: 3 months
Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Minimum necessay IPD will be shared with other researchers if trial is expanded to multiple sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriela E Halder, MD, MPH principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midurethral sling placed before robotic sacrocolpopexy and Midurethral sling placed after robotic sacrocolpopexy in people with Stress Incontinence Female and Pelvic Organ Prolapse, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha K Coghlan, MD (6019883613, mkcoghlan@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.