Bilateral replacement of the uterosacral ligaments with a polyvinylidene fluoride (PVDF) mesh (DynaMesh, FEG Textiltechnik mbH) is more effective than medical treatment with solifenacin (Vesicare) for achieving continence in women with urgency urinary incontinence (UUI) associated with only minor pelvic organ prolapse, according to the interim results of a prospective, randomized, crossover clinical trial.
Köln, Germany-Bilateral replacement of the uterosacral ligaments with a polyvinylidene fluoride (PVDF) mesh (DynaMesh, FEG Textiltechnik mbH) is more effective than medical treatment with solifenacin (Vesicare) for achieving continence in women with urgency urinary incontinence (UUI) associated with only minor pelvic organ prolapse, according to the interim results of a prospective, randomized, crossover clinical trial.
Findings from the URGE 1 study were presented at the AUA annual meeting in San Diego.
“The results of our study refute the idea that UUI cannot be cured by surgical intervention unless a patient has more advanced prolapse, and they are consistent with the hypothesis that UUI is caused by defective uterosacral ligaments,” said first author Sebastian Ludwig, MD, a urogynecologist at University Hospital of Cologne, Köln, Germany.
The idea for performing uterosacral ligament augmentation to treat UUI in women with POP-Q stage I was based on a published report showing that suturing of the vaginal cuff to the uterosacral ligament combined with a pubovaginal sling cured UUI in 82% of women who were POP-Q stage II-IV (J Urol 2003; 169:1770-4).
“Most women with UUI, however, are POP-Q stage I,” Dr. Ludwig said.
Dr. Ludwig and senior author Wolfram Jäger, MD, professor of urogynecology at University Hospital of Cologne, presented data from a total of 77 women with UUI who were randomized to treatment with solifenacin, 10 mg daily (n=37), or to surgical intervention (n=40). The surgery is an open abdominal procedure in which the PVDF tapes are fixed to the sacral bones and at either the cervix when the uterus is intact (cervico-sacropexy) or the vagina (vagino-sacropexy) using non-absorbable sutures (Gynecol Obstet Invest 2012; 74:157-64)(www.cesa-vasa.com).
The study had a crossover design such that women who did not achieve continence after 4 months of medical therapy or 4 months after surgery were offered the alternate therapy.
Continence, defined as absence of involuntary leakage, was achieved by 16 women (40%) randomized to surgery but by only two women (5.4%) in the medication group. A total of 29 of the 35 women who did not respond adequately to medication and all 24 of the women who did not achieve continence after surgery were treated with the alternate intervention; continence rates were 44.8% for women who crossed over to surgery and 4.2% among the women who began taking solifenacin.
Another analysis considered the length of time women were able to hold their urine without experiencing involuntary leakage. At baseline, 25 women in the solifenacin arm and 26 women in the surgical arm were not able to hold urine longer than 3 minutes without involuntary leakage. Of those women, 16 who had undergone surgery (62%) but only one woman on medication became able to hold urine longer than 10 minutes without involuntary leakage.
Dr. Ludwig acknowledged that total continence was a rigorous endpoint for assessing efficacy, but he defended its use.
“A woman who is seeking intervention for UUI will likely not consider her treatment very successful if she has merely improved from experiencing eight leakage episodes daily to five,” he said.
Women who were non-responders in the URGE 1 study were offered the opportunity to enroll in the URGE 2 study, a randomized comparison of transobturator tape (TOT) surgery versus solifenacin.
“The surgical procedure is done using our standardized ‘TOT 8/4’ approach (Biomed Res Int 2016; 2016:4941304 [Epub 2016 Feb 15]) that provides anatomical reconstruction of Level 1 and Level 3,” said Dr. Ludwig.
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