Exclusion of Elderly Women From Published Randomized Trials of Stress Incontinence Surgery

Morse, Abraham N.; Labin, Lisa C.; Young, Stephen B.; Aronson, Michael P.; Gurwitz, Jerry H.

doi:10.1097/01.aog.0000136484.37027.79

Cited by 46 publications

(24 citation statements)

References 11 publications

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“…With advancing age, detrusor hyperactivity and impaired contractility can lead to urinary retention, along with low maximum urethral closure pressure due to changes in sphincter enervation [8,10] . However, not enough data exist in the literature regarding the efficacy and safety of the well-established TVT procedure in elderly women [4] .…”

Section: Discussionmentioning

confidence: 99%

“…The tension-free vaginal tape (TVT) procedure, which was introduced by Ulmsten and Petros [2] in 1995, is nowadays the most frequent surgical intervention performed for SUI [3] . However, until recently elderly women were excluded from published randomized trials of stress incontinence surgery [4] . Treatment of SUI in elderly women is influenced by the higher incidence of comorbidities and detrusor and urethral physical alterations [5] .…”

Section: Introductionmentioning

confidence: 99%

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Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence in Geriatric Patients

Touloupidis

Papatsoris²,

Thanopoulos³

et al. 2006

Gerontology

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Objective: To evaluate the safety and efficacy of tension-free vaginal tape (TVT) for the treatment of stress urinary incontinence (SUI) in geriatric patients. Patients and Methods: Fifty-one women, aged 65–80 (mean 72.3) years, underwent a TVT procedure for genuine SUI from 2001 to 2004. A urodynamic test together with uroflowmetry were performed. The patients’ SUI bother score was assessed using a visual analog scale (VAS). Results: The mean operative time was 25 (range 14–29) min and mean hospitalization time was 1.2 (range 1–2) days. Bladder perforation occurred in 3 cases (5.8%) and was managed conservatively. Pre- and postoperative maximum flow rate were not significantly different (p > 0.05). The patients’ SUI bother score estimated by the VAS was statistically significantly improved (p < 0.0001). After a mean follow-up of 35.6 (range 14–60) months, 49 patients (96%) had no SUI, while 2 patients (3.9%) had persistent SUI. Also, during the follow-up 5 patients (9.8%) were diagnosed with de novo urgency due to detrusor overactivity and 1 patient (1.9%) had persistent dysuria that was resolved with urethrolysis. Conclusions: SUI in elderly women can be safely treated with the TVT procedure in the vast majority of the patients. However, bladder perforation during surgery and de novo urgency postoperatively should be taken into account.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence in Geriatric Patients

Touloupidis

Papatsoris²,

Thanopoulos³

et al. 2006

Gerontology

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“…A systematic review found the median percentage of women aged 70 or older who participated in surgical trials for SUI was 3.8%, while the number of surgeries for SUI performed on this population of women is estimated at 16%. 50 As the outcomes of surgery may be different in this population, the older woman should be encouraged to participate in clinical studies.…”

Section: Research Involving the Older Womanmentioning

confidence: 99%

Prolapse and Incontinence Surgery in Older Women

et al. 2008

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Purpose-Pelvic floor disorders including urinary incontinence, pelvic organ prolapse and fecal incontinence are common problems encountered by the older woman. With the increasing population of older American women, urologists and gynecologists can expect to provide evaluation and treatment of these conditions with increasing frequency. These conditions are amenable to both medical and surgical therapies.Materials and Methods-Contemporary published articles (year 2003 to present) that included older women undergoing urogynecologic surgical procedures were included in this review. Current data on morbidity, mortality and/or surgical outcomes are presented along with evidencebased pre, intra and post-operative surgical management strategies.Results-The older woman can expect similar operative risks as well as subjective and objective anatomic and quality-of-life outcomes as that of younger women undergoing pelvic floor surgery. Conclusion-The decision for surgical intervention for the treatment of pelvic floor disorders should not be based on chronologic age alone. Prior to selection of a specific surgical procedure, all existing pelvic floor defects should be evaluated. Further research is required to understand the impact that surgery for pelvic floor disorders has on anatomic, physiologic, and functional outcomes in older women.

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“…Pubmed search "older women and apical prolapse" revealed only one retrospective study specifically designed to examine postoperative outcomes among older women 11 .The underrepresentation of this group in clinical trials 12 further limits our ability to assess this important clinical area. The rich array of longitudinal inpatient, outpatient, and emergency room data from Medicare files is well suited to study outcomes after prolapse surgeries in women ≥ 65 years in the United States.…”

Section: Introductionmentioning

confidence: 99%

Readmission and Prolapse Recurrence After Abdominal and Vaginal Apical Suspensions in Older Women

Sanses

Hanley

Zhang

et al. 2017

Obstetrical &Amp; Gynecological Survey

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Objective-Our objective was to evaluate 30-day readmission, 12-month prolapse recurrence, and complications after apical surgeries in older women.Methods-A retrospective cohort study was conducted using [2002][2003][2004][2005][2006][2007][2008][2009][2010][2011] Medicare data in women ≥65 years who underwent abdominal sacrocolpopexy with synthetic mesh, or vaginal uterosacral, or sacrospinous colpopexy with 12-months follow-up. Vaginal mesh procedures were excluded. The primary outcome was 30-day inpatient readmission. Secondary outcomes were complications and prolapse recurrence, defined as either reoperation or pessary insertion. We used Pearson Chi-square, Fisher's tests and ANOVAs to examine difference between surgical treatment groups. Odds Ratio (OR) utilizing Charlson Comorbidity Index, age, race, and procedure type were calculated to assess the differences in the outcomes probability.Results-Out of 3015 women, 863 underwent abdominal sacrocolpopexy, 510 -uterosacral, and 1642 -sacrospinous ligament suspensions. The 30-day readmission was 7.4% (95% Confidence Interval (CI) 5.7-9.2%), OR= 2.4 (95% CI 1.7-3.5, p<0.01) after abdominal sacrocolpopexy, 4.5% (95% CI 2.7-6.3%), OR=1.3 (95% CI 0.8-2.1, p=0.3) after uterosacral compared to 3.5% (95% CI 2.6-4.4% p<0.01) after sacrospinous ligament suspensions. Prolapse recurrence did not differ between the groups 8.2% (95% CI 6.4-10.1%), 10.6% (95% CI 7.9-13.3%), and 9.9%, (95 CI 8.4-11.3%, p=0.3), respectively. Women had 30-day gastrointestinal complications 6.1% (95% CI 4.5-7.7%), 1.2% (95% CI 0.2-2.1%), and 1.1% (95% CI 0.6-1.6%, p<0.01); surgical site infections 5.9% (95% CI 4.3-7.5%), 3.1% (95% 1.6-4.7%) and 3.7% (95% CI 2.8-4.6%, p=0.01); genitourinary complications 10.9% (95% CI 8.8-13%), 17.7% (95% CI 14.3-21%), and 13.6% (95% CI 12-15.3%, p<0.01); and medical complications 7.4% (95% CI 5.7-9.2%), 7.8% (95% CI 5.5-10.2%), and 4.4% (95% CI 3.4-5.4%, p<0.01); (all after abdominal sacrocolpopexy, uterosacral, and sacrospinous ligament suspensions, respectively). HHS Public Access PrécisVaginal apical prolapse suspensions compared to abdominal sacrocolpopexy are associated with lower rates of postoperative 30-day readmissions without 12-month prolapse recurrence increase among older women.

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Exclusion of Elderly Women From Published Randomized Trials of Stress Incontinence Surgery

Abstract: Our review of the published literature suggests that elderly women are underrepresented in clinical trials of stress incontinence surgery. Efforts should be made to include more elderly women in clinical trials of stress incontinence surgery.

Cited by 46 publications

References 11 publications

Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence in Geriatric Patients

Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence in Geriatric Patients

Prolapse and Incontinence Surgery in Older Women

Readmission and Prolapse Recurrence After Abdominal and Vaginal Apical Suspensions in Older Women

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