A pilot randomized controlled trial to evaluate pelvic floor muscle training for urinary incontinence among gynecological cancer survivors, Rutledge TL, et al, Gynecol Oncol 132(2014)154-158.

Cindy Neville

Pelvic PT Distance Journal Club, April 8, 2015

Background:

Same authors previously reports high rates of UI (67% of 200) and sexual dysfunction among gynecological cancer survivors

Rutledge TL, Heckman SR, Qualls C, Muller CY, Rogers RG. Pelvic floor disorders and sexual function in gynecologic cancer survivors: a cohort study. Am J Obstet Gynecol 2010;203(5):514e1–7 [Epub 2010/09/28].

·         effectiveness of PFMT and behavioral therapy, has not been evaluated in gynecologic cancer survivors.

·         effectiveness of these interventions may differ in cancer survivors since radiation, chemotherapy and radical pel-vic surgery can result in significant anatomical functional changes in the pelvis and lower urinary tract, including damage of nerve fibers and compromise of vascular supply with resultant fibrosis.

Subjects: Fig 1

98 women screened for enrollment

inclusion: > 30, hx uterine, cervical, ovarian, or vulvar CA, dz and rx free x one year, no evidence of cancer,

58 were excluded, 23 refused to participate, 3 excluded for other reasons

40 women were randomized into 2 groups

1- usual care/ “no training” 3, dced intervention, 3 lost to f/u, n=17

2- PFMT + behavioral, 1 dced intervention, 1 lost to f./u n=19

no differences in 2 groups

obesity common

endometrial cancer most common

Methods:

Screened for UI using Sandvik ISI, QUID, UDI-6, IIQ-7

Randomized to group

Rx group-  handout and instruction describing behavioral management tips for urinary incontinence. information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urinary urgency by decreasing fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials ( based on Burgio KL, Kraus SR, Menefee S, Borello-France D, Corton M, Johnson HW, et al. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial. Ann Intern Med 2008;149(3):161–9 [Epub 2008/08/06].)

Rx group received a clinic visit in which the provider  confirmed appropriate contraction of the pelvic floor by palpation of the levator ani during a contraction and rated the strength of the contraction using the Brink's scale. The provider performing the training attended two pelvic floor physical therapy sessions with experienced pelvic floor PTs feedback was given to participants to avoid contraction of abdominal, gluteal, or adductor muscles.

PFMT training program was explained to the participant verbally and in written form. 10 pelvic floor muscle contractions with a goal of holding the contraction for 5 s; women were asked to perform 3 sets daily for the twelve week study period.

Rx groupreceived a re- minder phone call approximately four weeks after the first study visit.

Control group: usual care in clinic, no training, education, or exercises , same questionnaires, PFM assessment at 12 wks using the Brink's scale.

Both groups answered all questionnaires and Pt Global Impression (PGI) of Improvement scale at 12 wks

training program was offered to the women in the control group after they completed the study if still incontinent

Results:

Mean age 57

SUI most common based on QUID, 70%, mixed UI seen in 25% , median ISI score was 3 for rx group and 4 for control group, = moderate to severe UI; no change in this score after 3 months

the majority of women in the treatment group reported improvement in their urinary incontinence. At three months, 80% of the PFMT group and 40% of the control group reported that their urinary in- continence was “much better” or “very much better” as evaluated by the Patient Global Impression of Improvement scale (p = 0.02).

At three months, 70% of the PFMT group and 50% of the control group reported lack of bother from their urinary incontinence, as assessed by UDI-6,p = 0.62, not different.

No change in the condition specific quality of life scores (IIQ-7)   between the two groups as compared pre and post intervention.

treatment group demonstrated significant improvement in the measure of pelvic floor muscle function as measured by the Brink's score (p = 0.0001). The average Brink's score was 3 points higher in the treatment group at the three month evaluation compared with the study enrollment score.

Limitations: single center, small sample size, short duration and intensity of rx program, evaluator at 12 wks not blinded , PFMT no provided by qualified PTs

Strengths: random assignment, use of validated outcomes

Discussion:

three-month pelvic floor muscle training program in combination with behavioral therapy resulted in significant improvement in urinary incontinence symptoms for gynecologic cancer survivors; 80% of survivors felt their condition had improved or was cured versus a 40% improvement in the control group who received usual care.

PGI-I, ISI and Brink's scores all demonstrated significant improvement for the treatment group in our study.

No improvement in condition-specific quality of life or bother from incontinence was shown

Questions for discussion:

Why did they use the Brink scale? What other measure might have been more objective?

What type of training did they have by experienced pelvic PTs and who provided the intervention, all MDs?

What other interventions would have been appropriate since the majority had SUI?

Why did the severity score not change?

What other interventions might be offered to further improve  QOL and decr Sx in these women?