Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT03520114|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence Pelvic Floor Disorders||Device: RP sling placement Device: SIS placement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants and research staff will be masked during the one-year follow-up period.Precautions will be taken to minimize unmasking the study groups: Since RP slings require two suprapubic stab incisions, identical sham incision will also be performed in the SIS group.|
|Official Title:||Randomized Trial of Retropubic Versus Single-incision Mid-Urethral Sling (Altis ) for Concomitant Management of Stress Urinary Incontinence During Native Tissue Vaginal Repair|
|Actual Study Start Date :||December 12, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: RP sling group
Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
Device: RP sling placement
A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.
Experimental: SIS group
Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
Device: SIS placement
The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally.The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of NaCl. Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
- Number of participants with subjectively bothersome stress incontinence [ Time Frame: 12 months post-operatively ]Dichotomous outcome (Yes/No), measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
- Retreatment for stress incontinence [ Time Frame: 12 months post-operatively ]This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
- De novo or worsening urge incontinence symptoms [ Time Frame: 12 months post-operatively ]Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit
- Requirement for bladder drainage [ Time Frame: 12 Month post-operatively ]Beyond 2 weeks post-operatively with PVR > 150 ml OR > 1/3 total voided volume up to 12 Month post-operatively..
- Surgical intervention for urinary retention [ Time Frame: 12 Month post-operatively ]Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
- Adverse events [ Time Frame: 12 months post-operatively ]Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
- Change in pain [ Time Frame: up to 12 months post-operatively ]Pain will be measured on a visual analogue scale for 14 days post-operatively and at 6 weeks and 12 months post-operatively. The scale has a score range of 0-10, with 0=no pain and 10=worst pain .
- Surgeon satisfaction [ Time Frame: post-operatively up to 12 months ]Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale. The scale has a score range of 0-10, with 0=no satisfaction 10=extremely satisfied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520114
|Contact: Janet Shupingemail@example.com|
|Contact: Catherine Matthews, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Baptist Medical Center||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Janet Shuping 336-716-2612 email@example.com|
|United States, Rhode Island|
|Brown University and Women and Infants Hospital||Recruiting|
|Providence, Rhode Island, United States, 02905|
|Contact: Charles R. Rardin, M.D. 401-453-7560 firstname.lastname@example.org|
|Principal Investigator:||Catherine Matthews, MD||Wake Forest University Health Sciences|