Safety summary

Medical device discomfort or pain

Medical device discomfort was reported in 9% (8/89) of people who had external NMES and 1% (1/91) of people who had intravaginal electrical stimulation in the randomised controlled trial of 180 people. Medical device pain was reported in 5% (4/89) and 1% (1/91) of people, respectively (Dmochowski 2019).

Urinary disorders

Dysuria and micturition urgency were reported in 1 person each who had external NMES and in no people who had intravaginal electrical stimulation in the randomised controlled trial of 180 people (Dmochowski 2019).

Skin disorders

Erythema and rash were reported in 1 person each who had external NMES and pruritis was reported in 1 person who had intravaginal electrical stimulation in the randomised controlled trial of 180 people. Skin irritation was reported in 3% (3/89) of people who had external NMES and 1% (1/91) of people who had intravaginal electrical stimulation (Dmochowski 2019).

Musculoskeletal disorders

Arthralgia and myalgia were reported in 1 person each who had external NMES and in no people who had intravaginal electrical stimulation in the randomised controlled trial of 180 people (Dmochowski 2019).

Anecdotal and theoretical adverse events

In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never happened).

For this procedure, professional experts did not describe any additional anecdotal or theoretical adverse events.