Apparatus and method for treating female urinary incontinence

Apparatus for remodeling a treatment site within the urinary tract of a female patient, the urinary tract including a urethra and a bladder having bladder neck outlet, the apparatus comprising:

• an elongated shaft having proximal and distal ends and a diameter adapted to be inserted within the urethra;
• a handle secured to the proximal end;
• a balloon disposed on the elongated shaft adjacent the distal end, the balloon adapted to be inflated in the bladder to a diameter sufficient to prevent retraction of the balloon through the bladder neck outlet into the urethra;
• and
• a plurality of needle electrodes disposed circumferentially within the shaft and adapted to be coupled to a source of RF energy, the plurality of needle electrodes being selectively deployable from within the shaft to penetrate tissue surrounding the urethra,
• wherein the plurality of needle electrodes are disposed a predetermined distance proximally of the balloon, so that when the balloon is inflated within the bladder and retracted proximally, the balloon engages the bladder neck outlet and disposes the plurality of electrodes at the treatment site.

A method for treatment of female urinary incontinence in a human female having a urinary tract including a urethra and a bladder having a bladder neck outlet the method comprising:

• providing a device having a shaft with proximal and distal ends, a handle secured to the proximal end, an expandable member disposed adjacent the distal end, and a plurality of needle electrodes disposed a predetermined distance proximally of the expandable member and movable between retracted positions within the shaft and extended positions extending from the shaft;
• inserting the distal end and expandable member of the device through the urethra, through the bladder neck outlet and into the bladder;
• expanding the expandable member within the bladder;
• retracting the handle proximally to seat the expandable member against the bladder neck outlet, thereby aligning the plurality of electrodes with the treatment site;
• moving the plurality of needle electrodes from the retracted positions to the extended positions to advance the needle electrodes into tissue surrounding the urethra at the treatment site;
• and
• supplying radio frequency energy to the plurality of needle electrodes for a predetermined time to remodel tissue surrounding the urethra at the treatment site.