Pelvic Floor Disorders, Stress Urinary Incontinence
Conditions
Keywords
Retropubic sling, Single-incision sling, Vaginal repair, Management
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 Stress Urinary Incontinence (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.
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 Single-incision Mid-Urethral Sling SIS will be non-inferior to RP slings in efficacy and superior in irritative voiding symptoms/voiding dysfunction at one year after combined surgery.
Interventions
DEVICERP 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.
DEVICESIS 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 Sodium Chloride (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.
Sponsors
Foundation for Female Health Awareness
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants and 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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Needing Retreatment for Stress Incontinence | 12 months post-operatively | This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery. |
| Count of Participants Requiring Bladder Drainage | 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.. |
| Count of Participants Needing Surgical Intervention for Urinary Retention | 12 Month post-operatively | Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively. |
| Number of Participants With Subjectively Bothersome Stress Incontinence | 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 |
| Count of Participants With De Novo or Worsening Urge Incontinence Symptoms | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction Scores | 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. |
| Number of Participants With Adverse Events | 12 months post-operatively | Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system. |
Countries
United States
Participant flow
Recruitment details
Total 280 patients signed the Informed Consent. Out of enrolled 280 patients, 3 withdrawn as screen failed, 21 dropped out before randomization, and 1 did not receive the treatment as per randomization. Hence enrolled number is larger than the randomized.
Participants by arm
| Arm | Count |
|---|---|
| RP Sling Group Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
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. | 129 |
| SIS Group Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
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 Sodium Chloride (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. | 126 |
| Total | 255 |
Baseline characteristics
| Characteristic | SIS Group | Total | RP Sling Group |
|---|---|---|---|
| Age, Continuous | 67.8 Years STANDARD_DEVIATION 0 | 67 Years STANDARD_DEVIATION 12 | 65.5 Years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants | 244 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 24 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 111 Participants | 223 Participants | 112 Participants |
| Sex: Female, Male Female | 126 Participants | 255 Participants | 129 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 126 |
| other Total, other adverse events | 40 / 129 | 47 / 126 |
| serious Total, serious adverse events | 7 / 129 | 6 / 126 |
Outcome results
Primary
Count of Participants Needing Retreatment for Stress Incontinence
This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.
Time frame: 12 months post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RP Sling Group | Count of Participants Needing Retreatment for Stress Incontinence | 3 Participants |
| SIS Group | Count of Participants Needing Retreatment for Stress Incontinence | 5 Participants |
Primary
Count of Participants Needing Surgical Intervention for Urinary Retention
Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.
Time frame: 12 Month post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RP Sling Group | Count of Participants Needing Surgical Intervention for Urinary Retention | 3 participants |
| SIS Group | Count of Participants Needing Surgical Intervention for Urinary Retention | 4 participants |
Primary
Count of Participants Requiring Bladder Drainage
Beyond 2 weeks post-operatively with PVR \> 150 ml OR \> 1/3 total voided volume up to 12 Month post-operatively..
Time frame: 12 Month post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RP Sling Group | Count of Participants Requiring Bladder Drainage | 0 Participants |
| SIS Group | Count of Participants Requiring Bladder Drainage | 0 Participants |
Primary
Count of Participants With De Novo or Worsening Urge Incontinence Symptoms
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
Time frame: 12 months post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RP Sling Group | Count of Participants With De Novo or Worsening Urge Incontinence Symptoms | 3 Participants |
| SIS Group | Count of Participants With De Novo or Worsening Urge Incontinence Symptoms | 3 Participants |
Primary
Number of Participants With Subjectively Bothersome Stress Incontinence
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
Time frame: 12 months post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RP Sling Group | Number of Participants With Subjectively Bothersome Stress Incontinence | 129 Participants |
| SIS Group | Number of Participants With Subjectively Bothersome Stress Incontinence | 126 Participants |
Secondary
Number of Participants With Adverse Events
Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.
Time frame: 12 months post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RP Sling Group | Number of Participants With Adverse Events | 47 Participants with Adverse Events |
| SIS Group | Number of Participants With Adverse Events | 53 Participants with Adverse Events |
Secondary
Surgeon Satisfaction Scores
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.
Time frame: post-operatively up to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| RP Sling Group | Surgeon Satisfaction Scores | 9 Score on a Scale |
| SIS Group | Surgeon Satisfaction Scores | 8 Score on a Scale |