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Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT03520114
Recruitment Status : Not yet recruiting
First Posted : May 9, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of SUI that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis ™) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Pelvic Floor Disorders Device: RP sling placement Device: SIS placement Not Applicable

Detailed Description:
Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. Efficacy and risk always compete for equilibrium. Level I evidence has demonstrated a positive efficacy benefit of a concomitant synthetic mid-urethral sling in women with, and without, pre-operative symptoms of SUI who are undergoing POP repair. Concomitant sling placement has been shown to reduce the risk of de novo or persistent SUI from 50% to 23%. The combination of surgical treatment of POP and SUI at the same time, however, increases the risk of incomplete bladder emptying. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. As the combination of POP and sling surgery increases the risk of voiding dysfunction, and rates of incomplete bladder emptying appear significantly lower for SIS than RP slings, the study team hypothesizes that the use of the Altis ™ SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. Retreatment for stress incontinence [ Time Frame: 12 months post-operatively ]
    This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.

  3. 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

  4. 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..

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 .

  3. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 21 years of age
  • Women being considered for a native tissue vaginal repair in any vaginal compartment or colpocleisis
  • POP ≥ stage II of any vaginal compartment, according to the pelvic organ prolapse quantification (POP-Q) system
  • Vaginal bulge symptoms
  • Positive standardized cough stress test on clinical examination, or on urodynamic testing
  • Surgical plan that includes a native tissue vaginal repair including colpocleisis for symptomatic POP in any compartment
  • Understanding and acceptance of the need to return for all scheduled follow-up visits
  • English speaking and able to give informed consent
  • Willing and able to complete all study questionnaires

Exclusion Criteria:

  • Prior surgery for stress urinary incontinence
  • Status post reconstructive pelvic surgery with transvaginal mesh kits or sacrocolpopexy with synthetic mesh for prolapse
  • Any serious disease, or chronic condition, that could interfere with the study compliance
  • Unwilling to have a synthetic sling
  • Inability to give informed consent
  • Pregnancy or planning pregnancy in the first postoperative year
  • Untreated urinary tract infection (may be included after resolution)
  • Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)
  • Prior pelvic radiation
  • Incarcerated
  • Neurogenic bladder/ pre-operative self-catheterization
  • Elevated post-void residual (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study)
  • Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse repair
  • Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy.

Information from the National Library of Medicine

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


Contacts
Contact: Janet Shuping 336-716-2612 jshuping@wakehealth.edu
Contact: Catherine Matthews, MD camatthe@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Janet Shuping    336-716-2612    jshuping@wakehealth.edu   
United States, Rhode Island
Brown University and Women and Infants Hospital Not yet recruiting
Providence, Rhode Island, United States, 02905
Contact: Charles R. Rardin, M.D.    401-453-7560    crardin@wihri.org   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Catherine Matthews, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03520114     History of Changes
Other Study ID Numbers: IRB00050256
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Wake Forest University Health Sciences:
Retropubic sling
Single-incision sling
Vaginal repair
Management

Additional relevant MeSH terms:
Pelvic Floor Disorders
Urinary Incontinence
Enuresis
Surgical Wound
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Wounds and Injuries
Pregnancy Complications