Urinary Incontinence, Stress
Conditions
Brief summary
Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.
Detailed description
Objective of this study was to compare an inside-out TOT (Gynecare TVT Obturator System, Ethicon) with an innovative fixation SIS (Ophira, Promedon) in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI. A prospective randomized controlled trial (RCT) is performed in one tertiary referral urogynecology center from January 2015 thru December 2015. Study included women with pure or predominant urodynamic SUI confirmed during cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position. Study was carried out on a Caucasian Czech (central European) population. A study power analysis was calculated with an expected objective cure rate of minimum 80 % for both patient groups, false non-match rate (alpha) of 0.05, and false match rate (beta) of 0.10. A minimum sample size of 80 patients was required for each group.
Interventions
DEVICETOT - inside-out trans-obturator tape/sling
Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)
DEVICESIS - Innovative fixation single incision sling
Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)
Sponsors
Brno University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position.
Exclusion criteria
* patients with predominant urge incontinence * patients with intrinsic sphincter deficiency (MUCP\<20 cmH2O) * pelvic organ prolapse (POP-Q\>2) * previous urinary incontinence surgery * previous pelvic organ prolapse surgery * presence of other pelvic organ pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Negative Cough Stress Test (CST) | four years | Negative cough stress test four years after incontinence surgery. |
| Patient Global Impression of Improvement (PGI-I) Score | four years | Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians 1. Very much better 2. Much better 3. A little better 4. No change 5. A little worse 6. Much worse 7. Very much worse |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Major Perioperative Complications | one month |
| Number of Participants With Major Postoperative Complications | four years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SIS Single Incision Sling SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).
SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS) | 84 |
| TOT Trans Obturato Tape/Sling TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).
TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS) | 84 |
| Total | 168 |
Baseline characteristics
| Characteristic | SIS Single Incision Sling | TOT Trans Obturato Tape/Sling | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 10.6 | 62.3 years STANDARD_DEVIATION 10.3 | 63.3 years STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 84 Participants | 84 Participants | 168 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 | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 64 |
| serious Total, serious adverse events | 0 / 66 | 0 / 64 |
Outcome results
Primary
Patient Global Impression of Improvement (PGI-I) Score
Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians 1. Very much better 2. Much better 3. A little better 4. No change 5. A little worse 6. Much worse 7. Very much worse
Time frame: four years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SIS Single Incision Sling | Patient Global Impression of Improvement (PGI-I) Score | 1.4 units on PGI-I scale |
| TOT Trans Obturato Tape/Sling | Patient Global Impression of Improvement (PGI-I) Score | 1.3 units on PGI-I scale |
Primary
Percentage of Participants With Negative Cough Stress Test (CST)
Negative cough stress test four years after incontinence surgery.
Time frame: four years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SIS Single Incision Sling | Percentage of Participants With Negative Cough Stress Test (CST) | 86.4 percentage of participants |
| TOT Trans Obturato Tape/Sling | Percentage of Participants With Negative Cough Stress Test (CST) | 83.1 percentage of participants |
Secondary
Number of Participants With Major Perioperative Complications
Time frame: one month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SIS Single Incision Sling | Number of Participants With Major Perioperative Complications | 0 participants |
| TOT Trans Obturato Tape/Sling | Number of Participants With Major Perioperative Complications | 0 participants |
Secondary
Number of Participants With Major Postoperative Complications
Time frame: four years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SIS Single Incision Sling | Number of Participants With Major Postoperative Complications | 0 participants |
| TOT Trans Obturato Tape/Sling | Number of Participants With Major Postoperative Complications | 0 participants |