Synthetic vs Autologous Sling for Urinary Incontinence
(SASSI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two different surgeries to address stress urinary incontinence, a condition where urine leaks during activities like coughing or exercising. The researchers aim to determine the frequency of pelvic pain six months post-surgery and the number of people cured of incontinence five years later. They also examine other factors, such as pain medication use and mental and sexual health after surgery. This trial suits women over 60 who have tried other treatments for urinary incontinence without success and are ready for surgery. As an unphased trial, it offers a unique opportunity to contribute to research that may enhance surgical outcomes for others.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both autologous fascia slings and tension-free vaginal tape (TVT) are generally safe treatments for stress urinary incontinence. Studies indicate a moderate complication rate of 20% for the autologous fascia sling, but most side effects are manageable and don't cause long-term issues. Temporary problems like difficulty urinating can occur but usually resolve on their own.
Long-term studies confirm the high safety and effectiveness of tension-free vaginal tape. About 80% of patients experience significant improvement in their symptoms. The chance of needing additional surgery is low, ranging from 0% to 19% over five years. Both treatments have strong safety records, making them good options for managing stress urinary incontinence.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for urinary incontinence because they offer different surgical approaches to provide support to the urethra. The autologous fascia sling uses tissue from the patient's own body, which may reduce the risk of rejection and complications associated with synthetic materials. On the other hand, tension-free vaginal tape, a synthetic option, is known for being less invasive and typically allows for a quicker recovery time. These two options provide varied benefits, allowing for personalized treatment based on a patient's specific needs and circumstances.
What evidence suggests that this trial's treatments could be effective for urinary incontinence?
This trial will compare the effectiveness of two treatments for stress urinary incontinence: the autologous fascia sling (AFS) and tension-free vaginal tape (TVT). Research has shown that both AFS and TVT effectively treat this condition. Participants in the AFS arm may achieve complete bladder control in about 78.3% of cases, indicating significant symptom management. Meanwhile, those in the TVT arm may experience strong long-term outcomes, with up to 76.3% of patients showing lasting improvements even after 20–25 years. Both treatments have similar success rates, but AFS usually takes longer to perform. Overall, strong evidence supports both options in reducing symptoms of stress urinary incontinence.12346
Are You a Good Fit for This Trial?
This trial is for women over 60 who have stress urinary incontinence, have finished having children, and can attend clinic visits for up to five years. They should be able to undergo either tension-free vaginal tape or autologous fascia sling surgery after not improving with non-surgical treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery with either a mid-urethral synthetic mesh sling or tension-free vaginal tape (TVT) or an autologous fascia sling (AFS)
Follow-up
Participants are monitored for new onset pelvic pain and other post-op outcomes
Long-term follow-up
Participants are assessed for objective urinary incontinence cure rate and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Fascia Sling
- Tension-free Vaginal Tape
Trial Overview
The study compares two surgeries: a synthetic mesh sling known as tension-free vaginal tape (TVT) and an autologous fascia sling (AFS), made from the patient's own tissue. It looks at pain six months later and if incontinence is cured after five years, along with opioid use and mental health outcomes.
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Citations
Autologous Fascial Slings for Stress Urinary Incontinence
Results: Mean scores showed no statistically significant difference between the standard and short slings at the 17-year follow-up relating to ...
Outcomes and postoperative management of autologous ...
Conclusions: Autologous fascial pubovaginal slings when used as a non-primary surgical treatment for stress urinary incontinence can be effective in many cases.
Comparing Autologous and Mesh Slings for Stress ...
The autologous vaginal sling is used to treat stress urinary incontinence, which is defined by the International Continence Society as the ...
Comparison of Surgical Outcomes of Autologous Mid ...
Overall, both types of slings had similar cure rates but AFSs were associated with longer operative times. The study highlights the need for ...
Autologous mid- urethral fascial sling as a primary surgery ...
A high rate of complete continence (78.3%) and substantial patient-reported improvement support the efficacy of the procedure. While the ...
Autologous pubovaginal fascial sling from external oblique ...
According to a recently published retrospective study, 58.8% of patients were cured by the implementation of an AFPVS procedure, after the ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.