Sunday, June 10, 2012

Sexual Function and Quality of Life of Women with Stress Urinary Incontinence: A Randomized Controlled Trial Comparing the Paula Method to Pelvic Floor Muscle Training Exercises. Liebergall-Wischnitzer M, Paltiel O, Celnikier D, Lavy Y, Manor O, Wruble A. J Sex Med. 2012, 9(6):1491-1721.

Pelvic Physiotherapy Distance Journal Club June 6, 2012
Michelle Spicka, DPT

Objective:  Comparing the effectiveness of the Paula method vs. the PFMT (pelvic floor muscle training) on sexual function (SF) and quality of life (QoL) of women with SUI.

The Paula Method is a circular muscle exercise protocol that works on the premise that all sphincters in the body are synchronized with the movement of one affecting the other.  The Paula method theory claims that one can rehabilitate damaged muscles by contracting and relaxing specific “circular” muscles in other areas of the body.  The exact mechanism is unknown though speculations have been raised that one sphincter affects others due to oscillations in the spinal cord.  The Paula method has been used in Israel for several decades and found to be effective in some clinical trials.

Subjects:  Women aged 20-65 with SUI symptoms (exclusion included pregnancy, breastfeeding women, 6 months post pelvic surgery, grade 3 or higher POP, pelvic radiation or other physical or mental limitations that limited physical activity).

Study Design/Method:  Participants were randomized to one of two research groups (Paula method or PFMT) and stratified by age and place of residence.  Nurses who performed the pad test and the research coordinator were blinded to the intervention group and baseline status.

The Incontinence Quality of Life Questionnaire and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire were administered before the intervention and after the 12 week intervention period.

Paula intervention (66 women): Three certified Paula method instructors worked with the participants which included one 45 minute private session per week for 12 weeks.  Paula exercises included the following: contracting and relaxing eyelids; contracting and relaxing the levator ani muscles alone or with long “sh” sound.

PFMT intervention (60 women): Ten PTs worked with PFMT groups which included 1-10 people for 30 minutes once a week for 4 weeks then 2 additional sessions 3 weeks apart were completed.  The PFMT exercise included the following: identifying the levator ani by raising the vagina from the chair the person is sitting on; contracting and releasing the levator ani muscle with prolonged contractions or rapid contractions or gradual contractions.

Comparison of group treatments:
Paula  group: 12 sessions, 45 min one-on-one session
PFMT group: 6 sessions, 30 min group session

Outcome/Results:  Both groups improved after the interventions with significant increases in the mean SF and QoL scores.

Conclusion: This RCT study demonstrated the effectiveness of 2 exercise methods on SF and QoL in women with SUI, adding important information to the limited knowledge of exercise as an effective treatment.  It supports exercise interventions as a first-line conservative management technique for women with UI and sexual dysfunction.

Additional Research:
1.       Liebergall, et al (J Womens Health. 2009 Mar;18(3):377-85.) found both the Paula method and pelvic floor muscle training were efficacious in women with SUI; the results suggest superiority of the Paula method in terms of cure rate (15.2% more “cures” in those randomized to the Paula method).  It should be noted there was a drop out rate of 26.6%, though.
2.       Liebergall, et al (Int Urogynecol J Pelvic Floor Dysfunct. 2005 Sep-Oct;16(5):345-51) performed a pilot study of 59 women who were randomly assigned to PFMT or the Paula method and found the Paula method was efficacious for SUI in that particular population of Israeli women.  It should be noted that both groups did show significant changes in urinary leakage compared to baseline.
3.       Resend, et al (Int Urogynecol J 23 Nov 2010) found the Paula method seems not to increase PFM activity in nulliparous women (without pelvic floor dysfunction). EMG of normals
4.       Bo, et al (Int Urogynecol J 23 Nov 2010) found the Paula method did not facilitate PFM contraction. 4D US of pregnant or postpartum women

Thought Questions:
1.       What does this mean for our clinical practice?

Journal club discussion
There was much discussion of the use of overflow / facilitation versus isolated PFM training.  The large volume of high quality studies are on isolated training however there is some (less powerful) evidence of the benefit of overflow / facilitation.  Large high quality studies are needed. 

Some of the overflow techniques are
·         Paula method
·         Beyond Kegels
·         Pilates
·         Postural restoration
·         Ball exercises
·         Group exercises

This article points out the decrease in detrusor contractions while swallowing

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