Adjustable mini-sling compared to conventional mid-urethral slings in women with urinary incontinence. 3-year follow-up of a randomized controlled trial.

Alexandridis V1, Rudnicki M2, Jakobsson U3, Teleman P1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 241
Female Stress Urinary Incontinence
Scientific Podium Short Oral Session 12
Wednesday 29th August 2018
16:52 - 17:00
Hall B
Stress Urinary Incontinence Clinical Trial Grafts: Synthetic New Devices
1. Department of Obstetrics and Gynecology, Skåne University Hospital, Lund University, 2. Department of Obstetrics and Gynecology, Odense University Hospital, 3. Center for Primary Healthcare Research, Faculty of Medicine, University of Lund
Presenter
V

Vasileios Alexandridis

Links

Abstract

Hypothesis / aims of study
To compare the long-term subjective outcomes of an adjustable single-incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS) in women with stress urinary incontinence (SUI).
Study design, materials and methods
The study was designed as a multicenter prospective randomized trial with women included from eight centers in three countries. Women under 60 years old with objectively verified stress urinary incontinence were randomized in blocks to SIMS or SMUS (TVT, TVT-O or TOT). A subjective cure rate of not less than 9% was anticipated in the SIMS group and using a one-sided test with the alpha value set to 5% and a power of 80%, the inclusion of 131 women was required in each arm. The data of 280 women was analyzed at one-year follow-up with no significant difference in objective or subjective outcomes (1). At 3-year follow-up women were evaluated regarding the subjective outcomes using the ICIQ-UI SF, ICIQ-OAB, PISQ-12, PGI-S and PGI-I questionnaires together with bladder diary. Subjective cure was defined as statement of no leakage in the ICIQ-UI SF or no leakage stated in the bladder diary.
Results
In total 205 women participated in the 3-year follow-up; 107 in the SIMS and 98 in the SMUS group, with common baseline characteristics (Table 1, 2). No difference between the groups was observed regarding subjective cure rate, urgency, urge urinary incontinence, de novo dyspareunia or postoperative improvement. Number of micturitions per day was significantly lower in the SIMS group (Table 3). Subgroup analysis showed that women with mixed urinary incontinence (MUI) in the SMUS group demonstrated higher rates of improvement than women in the SIMS group (Table 4) and over-the-time analysis indicated an improvement regarding urge urinary incontinence for women in both groups after one year that remained at the same level at 3-year follow-up (Table 5).
Interpretation of results
SIMS appears to perform equally to SMUS at 3-year follow-up of women with stress urinary incontinence with respect to patient-reported outcomes. Signs of variation exist concerning the number of micturitions per day and the improvement of the subgroup of women with mixed urinary incontinence. The positive effect of both methods on urge urinary incontinence seems to stabilize after one year.
Concluding message
The long-term effect of SIMS is comparable to that of SMUS regarding subjective postoperative outcomes.
Figure 1
References
  1. Rudnicki M, von Bothmer-Ostling K, Holstad A, Magnusson C, Majida M, Merkel C, Prien J, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial. Acta Obstet Gynecol Scand 2017; 96: 1347-1356.
Disclosures
<span class="text-strong">Funding</span> Lund University <span class="text-strong">Clinical Trial</span> Yes <span class="text-strong">Registration Number</span> ClinicalTrials.gov: Registration Number: NCT01754558 <span class="text-strong">RCT</span> Yes <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Local ethics committee of Region Zealand, Denmark. Regional ethics committee of Lund, Sweden. Ethics committee of Norway, REK. <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes