Trial Outcomes & Findings for Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence (NCT NCT02506309)

Results Overview

Negative cough stress test four years after incontinence surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

168 participants

Primary outcome timeframe

four years

Results posted on

2020-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	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)	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)
Overall Study STARTED	84	84
Overall Study COMPLETED	66	64
Overall Study NOT COMPLETED	18	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SIS Single Incision Sling n=84 Participants 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)	TOT Trans Obturato Tape/Sling n=84 Participants 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)	Total n=168 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 10.6 • n=5 Participants	62.3 years STANDARD_DEVIATION 10.3 • n=7 Participants	63.3 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	84 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: four years

Negative cough stress test four years after incontinence surgery.

Outcome measures

Outcome measures
Measure	SIS Single Incision Sling n=66 Participants 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)	TOT Trans Obturato Tape/Sling n=64 Participants 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)
Percentage of Participants With Negative Cough Stress Test (CST)	86.4 percentage of participants	83.1 percentage of participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SIS Single Incision Sling n=66 Participants 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)	TOT Trans Obturato Tape/Sling n=64 Participants 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)
Patient Global Impression of Improvement (PGI-I) Score	1.4 units on PGI-I scale Interval 0.0 to 7.0	1.3 units on PGI-I scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: one month

Outcome measures

Outcome measures
Measure	SIS Single Incision Sling n=84 Participants 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)	TOT Trans Obturato Tape/Sling n=84 Participants 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)
Number of Participants With Major Perioperative Complications	0 participants	0 participants

SECONDARY outcome

Timeframe: four years

Outcome measures

Outcome measures
Measure	SIS Single Incision Sling n=66 Participants 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)	TOT Trans Obturato Tape/Sling n=64 Participants 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)
Number of Participants With Major Postoperative Complications	0 participants	0 participants

Adverse Events

SIS Single Incision Sling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TOT Trans Obturato Tape/Sling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

dr. Martin Huser

Brno University Hospital

Phone: +420532233843

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place