Outcomes of the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms (GLADIOLUS) Study - Diane Newman

July 17, 2023

Diane Newman shares the outcomes of the GLADIOLUS study, a randomized controlled trial examining the efficacy of a group-administered behavioral treatment for older adult women with urinary incontinence (UI). The trial compared the effectiveness of a structured bladder health class against a brochure covering bladder training and pelvic floor muscle training. This study involved women over 55 who hadn't received prior treatments for UI, recruited from multiple universities across the U.S. Results showed a significant improvement in UI symptoms for women who took part in the bladder health class, leading to reductions in UI frequency, severity, and distress, along with enhanced quality of life. These improvements were observed regardless of changes in pelvic floor muscle strength. Dr. Newman suggests that such group-based interventions are effective, easily scalable, and can reach large populations, potentially being implemented at community centers, hospitals, or medical practices.


Diane K. Newman, DNP, ANP-BC, BCB-PMD, FAAN, Adjunct Professor of Urology in Surgery, Research Investigator Senior, Perelman School of Medicine, University of Pennsylvania, and Former Co-Director of the Penn Center for Continence and Pelvic Health, Philadelphia, PA

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Diane Newman: Welcome. I'm Diane Newman. I'm an adult nurse practitioner and continence nurse specialist. For the past 15 years, I've been doing research in this area. And I've had two large research projects looking at the use of a bladder health class. And both of those have been published. And I thought I'd share with you one of the outcomes of the GLADIOLUS study where we looked at women with urge incontinence to see whether their symptoms improved. It was called Group-Administered Behavioral Treatment in Reducing Urinary Incontinence in Women. And it was a randomized controlled trial. So, I think that this would be really helpful in your practice. So, group learning achieves decreased incidents of lower urinary tract symptoms, or The GLADIOLUS Project. Now the aim of this study was to compare the effectiveness of a novel group administered behavioral treatment to no treatment in older adult women with stress, urgency or mixed urinary incontinence in a multi-center setting.

And this was based on previous research, which was the use of a bladder health class. It was a prospective randomized controlled trial. And basically what that means is that we had one group receive the class, the other group was randomized to just a brochure that we developed, which is a handout about bladder training, pelvic floor muscle training. And it was a multi-site study where we enrolled individuals at the University of Pennsylvania in Philadelphia, University of Alabama in Birmingham, and the University of Michigan in Ann Arbor. How did we get these women? Well, we did mass mailing recruitment letters were sent to women over the age or equal to 55 years of age. And they had to be treatment naive, and I think that's what's important about this study because a lot of the studies that you see on drug therapy for, say, overactive bladder urgency frequency, patients have previously been treated.

These women could not have been previously treated, either with drug, surgery or behavioral therapy. They were pre-screened by phone, and then they were referred for our individual centers. And we did baseline screening and randomization. Our inclusion/exclusion criteria is they had to be over or equal to age of 55. They had to have stress urgency or mixed UI based on the ICIQ. So, that is a questionnaire that's validated and used a lot for research, which asks them questions about stress incontinence urgency frequency, but they had to have symptoms for three months or more. They could not have pelvic organ prolapse, pelvic cancers or bladder surgery. They could not have again, prior treatments. And then the ICI-UI short form score greater than three, which means that they had to have one or more score for urinary leakage and one or more score for volume loss, so severity of the urine loss.

And this is our two groups which we randomize. The group bladder treatment was teaching protocol to our face-to-face group session. It was a class and you can see all the information in that class. It was a self-management information. They also received a CD of the exercise program that you'll find on this website, that walked them through pelvic floor muscle exercises. The control got just a pamphlet., And at the end of the study the study was 12 months long, so we followed them over 12 months, they were given the CD. And this is exactly what we gave them. So, you can see the brochure on the left. They got a little magnet that they put on their refrigerator as far as to remind them to do the exercises, and then they got the CD that was an exercise that actually I recorded. Now the outcome measures were the change in ICIQ, urinary incontinence short form. Secondaries, we did have them do a three-day bladder diary.

Pad weights, we actually weighed pads in this group, provocative cough stress tests and other validated measurements to look at quality of life. And we also did a pelvic floor muscle strength test, which is the Brink test, which has been used in research before, that actually with digital palpation, you have the patient tighten around your fingers with the pelvic examination, and you would rate the duration, the strength of the contraction. There's a scale that we use that's been validated. So, these patients went through four of those examinations. Okay? The evaluator who did the exam was blinded, so they did not know which group that individual went to. And again, we saw them at baseline three months, six months, and nine months, and 12 months. The results, we randomized 463 women evenly split between two groups. We only had 7.3% withdrawal over those 12 months.

The retention of the study was absolutely excellent. You don't see that in a lot of studies. Usually, people fall out, but not in this. There were no differences between the groups in age, race, education, income, living with a partner, BMI, medical and surgical histories. And this is the demographics. You see that we had a good percentage of almost 50% of black African American. We did have Hispanic in smaller numbers. And again, in a lot of incontinence, overactive bladder studies, you have mostly Caucasian, but we really hit a nice number of African American. And you can see the educational level. The thing that is interesting is this is a fairly highly educated group of individuals, their employment and their annual household income. Outcomes, there was no significant differences between the group bladder treatment and control in the primary and secondary outcomes for baseline.

In the follow-up, there was significant increase in the Brink pelvic floor muscle strength. There was no significant differences in the Brink's testing of the pelvic floor muscle. And these are the scores. Okay? We hit statistically significance though at the six, nine and 12 months. So, the longer they did and after they learned about the bladder health class, and the longer they practiced those behavioral treatments, you saw improvement. So, basically in the secondary outcomes, there was significant improvement in favor of the bladder health class over control in all time points. And the number of leaks on a three-day diary went down. 24 hour pad tests, provocative cough stress tests, the MESA questionnaire score, the incontinence quality of life, and the patient global impression-improvement. And this is the data that you can see that improvement.

And again, this class literally improve these patient symptoms, treatment-naive women with urgency incontinence. And the pelvic floor muscle score as far as changing their pelvic floor muscle strength didn't improve that much. And that's why a lot of us feel that the pelvic floor muscle, the strength may not be as important as the use of the muscle when you need the muscle, like the stress strategy. And that was part of the class that we taught them. So, that might be more important. And as far as the patient global impression of their improvement was significantly improved in the bladder health class group. So, basically a novel group behavioral treatment, we say group because the class had at least five or above women. And there's probably something about the fact that the women were together that could share their stories, ask questions, learn from one another, that may have been part of the intervention.

It was effective in reducing UI frequency, severity and bother, improving quality of life for all levels of UI severity per ICIQ-UI short form and baseline, regardless of lack of pelvic floor muscle strength improvement. So, this is an easily scalable intervention that increases the opportunity to reach large populations. So, I thought that might be helpful for you to see as far as what can work. Classes can be done at community centers, at your hospital, at your practice. You can train community partners to do the class, but basically they can improve symptoms. Thank you very much.
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