Short and Medium-Term Results of the Autologous Adult Mucosa Stem Cell Therapy Compared with Mini-Sling Surgery in the Treatment of Women's Stress Urinary Incontinence; A Randomized Clinical Trial.

OBJECTIVE: This study aimed to compare the results of stem cell therapy with mini-sling for women's stress urinary incontinence. METHODS: This study was a parallel groups noninferiority randomized clinical trial. Patients with pure stress urinary incontinence who did not improve after three months of conservative and medical therapy were included. Patients were divided into two groups mini-sling insertion or peri-urethral injection of the autologous mucosa stem cell with simple equal randomization. Standard Incontinence Impact Questionnaire (IIQ) for patients' satisfaction as well as objective Marshal Test as primary outcomes were compared. RESULTS: From October 2016 to March 2018, 30 patients (mean age of 52 years) were randomly divided equally into two groups. Finally, a negative Marshal test was observed in 73% of the stem cell group vs. 80% in the mini-sling group (p = 0.6). The mean decrease in the IIQ results was 12 points in the stem cell group vs. 25 points in the mini-sling group (p = 0.05). Favorable results at 6 m and 26 m follow-up were 40% vs. 80% (p = 0.06) and 53% vs. 60% (p = 0.7) in stem cell and mini-sling group, respectively. Patients in the mini-sling group experienced a higher rate of dyspareunia. Intervention time and hospital stay were 6.46 ± 1.24 minutes vs. 19.40 ± 4.30 minutes (p = 0.001) and 4.33 ± 1.23 vs. 9.20 ± 3.16 hours (p = 0.001) in stem cell and mini-sling groups, respectively. CONCLUSION: Results of the periurethral injection of the autologous adult mucosa-derived stem cells are not inferior to the less invasive mini-sling procedure; while, the stem cell group showed shorter intervention time and hospital stay as well as fewer complications. This noninferiority pilot randomized trial compared the results of stem cell therapy with mini-sling surgery and showed that in the medium-term followup, the results are comparable.

Simultaneous treatment of anterior vaginal wall prolapse and stress urinary incontinence by using transobturator four arms polypropylene mesh

PURPOSE: To evaluate the medium-term efficacy and safety of transobturator four-arm polypropylene mesh in the treatment of high-stage anterior vaginal wall prolapse and concomitant stress urinary incontinence (SUI). MATERIALS AND METHODS: Between September 2010 and August 2013, a prospective single-center trial was performed to evaluate women with stage> or =3 anterior vaginal wall prolapse with or without SUI who presented to Labbafinejad Hospital, Teheran, Iran, and underwent anterior vaginal wall repair with polypropylene mesh. Pre- and postoperative evaluation included history; physical examination using the Pelvic Organ Prolapse Quantification system and cough stress test, both before and after reduction of prolapsed structures; Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ); urinalysis and culture; and a postvoid residual assessment. Complications were reported at a mean of 2 years of follow-up. RESULTS: A total of 71 patients underwent cystocele repair with the transobturator four-arm polypropylene mesh. Seven of the patients were lost to follow-up. There were no perioperative complications. The anatomical success rate was 87.5%. The subjective success rate was 92.1%. The PFDI and PFIQ were significantly improved after surgery (p<0.001). Among those with the simultaneous complaint of SUI, 82% were cured without any additional procedure. Three patients (4.6%) experienced vaginal mesh extrusion. Two patients (3.1%) reported worsening of dyspareunia after surgery. CONCLUSIONS: The four arms polypropylene mesh is an effective device for simultaneous correction of anterior vaginal wall prolapse and SUI with a low complication rate at a medium-term follow-up. The majority of the subgroup with concomitant SUI were cured without a second simultaneous procedure.