Single blind, randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women

Bo K, Talseth T, Holme I. Single blind, randomized controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999, 318:487-493.

Subjects: 107 females 24 to 70 yo

Groups – 6 months of treatment

• PFM exercises – 8 to 12 contractions TID with weekly PT visits
• Electrical stimulation – intermittent, 50 Hz, 30 min qd, monthly PFM re eval, instructed not to do PFM contractions
• Vaginal cones – 20 min per day, monthly PFM re eval
• Control – given pads

Outcomes

• Pad test
• Subjective assessment
• 3 day leak index
• 12h pad test
• Leakage index
• Social activity index

Results

• Adverse events
• PFM exercise group – none
• Electrical stimulation – 2 pain, 8 motivation and trouble using device
• Canes – 1 abd pain, 2 vaginitis, 1 bleeding, 14 motivation and trouble using device
• Sig greater improvement in PFM pressure in PFM exercise group over all others
• Decrease in pad use was sig higher in PFM exercise group over all other groups.
• No sig difference between electrical stimulation and vaginal cone group.
• No significant change in max urethral closure pressure for any group – do not see where this was one of their outcomes measures.
• 3 day leak index showed some significant (0.047) electrical stimulation vs control

Limitations of study were not reported, these are issues I have concern about

• Initial 24 h pad test was sig different in PFM group – 14.5 g vs cones group 52.3 g
• Also seems the initial PFM strength was different initially – PFM exercise group 11.0 cm H2O vs electrical stimulation 14.8
• Results social index was exactly the same for PFM exercise and electrical stimulation groups
• Ending PFM strength was almost the same PFM exercise (19.2) vs electrical stimulation (18.7).  Study reported change in PFM strength and because PFM exercise group started with less strength this item became significant.
• Discussion calls this a pragmatic study – attempting to reproduce clinical practice.  While it may be possible that electrical stimulation is handed to a patient and used without professional guidance (as this study suggested) I would say few PTs in the US use this model.  Most will see patients in clinic and most encourage PFM exercises during treatment. 
• Electrical stimulation has been studied in many different ways.  In my view electrical stimulation was not represented well in this study and deserves further research.