Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms

Lead Sponsor

Uroplasty, Inc

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
•Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
•Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
•Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
•Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
•Subjects must remain off all antimuscarinics throughout participation in trial
•Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
•Capable of giving informed consent
•Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years

•Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
•Subjects who were not able or willing to follow original SUmiT Trial study schedule

Related studies

NCT07366918 · Urinary Bladder, Overactive

NCT05968885 · Urinary Bladder, Overactive, Urodynamics, and more

NCT06933407 · Urinary Incontinence, Urinary Incontinence, Stress, and more

NCT06336304 · Urinary Incontinence, Urinary Obstruction, and more

NCT01558856 · Urinary Bladder, Overactive