Does Bladder Training Improve the Efficacy of Nerve Stimulation in Women With Refractory Overactive Bladders

NACompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

July 24, 2014

Primary Completion Date

March 31, 2019

Study Completion Date

March 25, 2019

Conditions
Overactive Bladder
Interventions
BEHAVIORAL

Bladder Training (BT)

All patients randomised to PTNS + BT group will have BT with the nurse for 20 minutes during PTNS sessions (which last 30 minutes). Since BT is recommended by NICE for a duration of 6 weeks. BT will be discussed for the first 6 sessions of the 12 week PTNS treatment cycle.

DEVICE

Percutaneous Tibial Nerve stimulation

"A needle electrode insertion site is located on the inner aspect of either leg approximately three fingerbreadths (5 cm or 2) cephalad to the medial malleolus and approximately one fingerbreadth (2 cm or ¾) posterior to the tibia. The needle electrode head is gently tapped to pierce the skin, maintaining a 60° angle, and insert to a depth of approximately 2cm. The electrode is then connected to the stimulator and the current setting needed is determined by the test mode on the stimulator. Once the current setting is known, the stimulator is started on the therapy mode which delivers the current for 30 minutes and shuts off automatically after 30 minutes. The needle is then removed and stimulator disconnected. The treatment involves twelve weekly sessions of 30 minutes each."

Trial Locations (1)

PL6 8DH

Plymouth Hospitals NHS Trust (PHNT), Plymouth

All Listed Sponsors
lead

University Hospital Plymouth NHS Trust

OTHER

NCT02107820 - Does Bladder Training Improve the Efficacy of Nerve Stimulation in Women With Refractory Overactive Bladders | Biotech Hunter | Biotech Hunter