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Saturday, May 11, 2013

TRANSVAGINAL E-STIM with SURFACE EMG BIOFEEDBACK IN MANAGING STRESS UI IN WOMEN OF PREMENOPAUSAL AGE: A double-blind, placebo-controlled, randomized clinical trial

Terlikowski, R, etal International Urogynecology Journal – 27 February 2013
Reviewer:  Jane O’Brien, PT, MSPT – 05.08.13
Background:   PFMT for SUI can have improvement rates as high as 70% short term… Long term declines to 50% maybe due to declining adherence rates to program.
ES helps strengthen PFM, ease SUI, can help control urgency by acting on nerves and decreasing bladder irritability. Ideal parameters seem to be 20-50HZ, 15-30 min, at max tolerable intensity for 4-12 weeks.
Surface EMG (sEMG) , evals SUI treatment outcome by recording change in voltage over the muscle fiber membrane that initiates the contraction. Skeletal muscle: relationship btw EMG activity and force ie higher activity level correspond to increase force.

Biofeedback: electrodes transduce muscle potentials into an auditory or visual signal to help person to learn to increase or decrease the muscle activity.
Strong evidence exists for TVES as effective treatment for SUI, but not as much on other therapies.
 
Primary Aim – To evaluate results of Transvaginal E-Stim (TVES and SEMG) for Stress UI in premenopausal women.
Subjects: 
 102 Premenopausal Women with Stress UI
 Group 1 Active – 68 ( TVES+sEMG),
 Group 2 Placebo – 34 ( same but parameters were set to level of no physiological effect.. 2hz, 50 us, 2 s stim, 60 s off, ramp of 8s.)
 Patients with urodynamically confirmed SUI were Randomized via computer generated random sequence given in sealed envelope to Group 1- active 68 and Group 2 – placebo 34.
 Groups were similar at start

Study Method –
Participants were taught ways to prevent incontinence and suppress urge via education on bladder control, lifestyle interventions ( wt. redux, relieving constipation, smoking cessation, caffeine redux, fluid mgmt, clothing, redux stress, habit/behaviors correction and voiding position)
Initial exam: POP and PFD assessment in sitting and after voiding, PFM strength via palpation, GYN palpated int/ext vaginal and rectal muscles for pain, strength, coordination, endurance. Oxford scale used for effort ( 0 nil, 1 flicker, 2 weak, 3 medium with slight lift of finger and on resistance, 4 strong lifts finger with light resistance, 5 very strong, lifts finger against strong resistance.)
Cough stress test done : Post void residual obtained, bladder filled to 300 ml, pt coughed with Valsalva while supine. If no leak, same procedure done in standing. ( + if leakage occurred).
Uroflowmetry performed on all participants. Bladder emptied via Catheter, filled via Foley Cath, 250 ml. distilled water. Pt stood with pre-weighed pad in underwear for the tests ( see below), pad reweighed after tests for net weight. Leakage more than 1 gram is positive.
Cough 10X, bear down ten times, 10 knee bends, jump up and down 10 x, wash hands under cold water 1 min, walk up and down 5 stairs 10 x, walk hall 10 min,

Treatment:  8 weeks – 2 sessions a day – Both groups were taught by PT, treatments were done at home, weekly monitor of machine for compliance.
Group 1: TVES with sEMG (10-40Hz, 200-250us, 15s/30s duty cycle, 20 min increased to 40 min),
Group 2: TVES with sEMG 2Hz, 50 us, 2 s on, 60off, ramp 8s.
Evaluated Pre and Post with
  *Pad Test (three 24 hour, weeks 0,8,16), five pads, worn max 6 hrs, except at night. After use, sealed in sealed bag given to tester.  Positive if wt exceeded 8g.
  * Voiding Diary (7days)
  * Urodynamics Test see page 14 of study.
  * Individual Quality of Life (I-QOL) Scores 100 best, 0 worst. Done at weeks 0,8, 16.
Double Blinded – subjects / yes; Treating Therapist and MD assessors/Treating GYNs / yes

Assessing Outcomes – all participants were accounted for:
Dropouts:  Group 1 / 64 – 4 W/D
       Group 2 / 29 – 5 W/D
Treatment Effect / Results
 Mean urinary leakage on 24 hour pad test: significant reduction after 8th week in Active Group (19.5±13.6 vs 39.8±28.5)

Mean urinary leakage on 24 hour pad test:  signif. Redux in active group at end of week 8 and week 16 vs placebo.– ( 8.2±14.8 vs 14.6±18.9 and 6.1±11.4 vs 18.2±20.8)
 significantly improved muscle strength on Oxford scale after week 8 and 16.(4.2 vs. 2.6 and 4.1 vs. 2.7)
 7 Day void log – no change between groups in frequency. But, Group 1 had decrease in Severity of sx  ofurine loss, nocturia, and number of pads used.

Severity of symptoms reduced in Group 1as shown on I-QOL score ( 78.2 ±17.9 vs 55.9 ±14.2 week 8 and 80.8 ±24.1 vs 50.6 ±14.9 for week 16. )

Urodynamic data… no signif difference btw groups.
Conclusion
TVES and SEMG trustworthy treatment for premenopausal women with SUI – but reliability needs to be stablished
Clinical significance
1.)PFM strength increases most with TVES and sEMG in first 2 months, stays preserved month 4.  Helps with compliance, goal setting.
2) Can help teach isolation of PFMs
3) Effective treatment for the busy patient who cannot attend PT/ltd. PT visits. 
4) is TVES with EMG more effective than TVES alone?

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