Endoscopic injection of glutaraldehyde cross-linked collagen for the treatment of intrinsic sphincter deficiency in women.
OBJECTIVE
To determine the clinical efficacy, safety, and durability of endoscopically injected glutaraldehyde cross-linked (GAX) collagen for the treatment of intrinsic sphincter deficiency (ISD) in women.


METHODS
Forty-two women with a mean age of 64 years (range, 28 to 88) underwent injection of GAX collagen for ISD. Collagen was injected via a transurethral or periurethral approach. Treatment outcome was based on the change in stress leak point pressures (SLPP) and individual incontinence grades before and after collagen injection.


RESULTS
With a mean follow-up of 46 months (range, 10 to 66), 83% were cured (n = 17), greatly improved (n = 5), or improved (n = 13), and 17% were unchanged (n = 3) or worse (n = 4). The median number of treatments was 2 (range, 1 to 8). The 22 women greatly improved or cured required a mean of 2.4 collagen injection treatments, whereas the 20 women who were improved, unchanged, or worse had a mean of 4.1 treatments (P = 0.009). The mean amount of collagen injected per patient was 28.3 cc (range, 2.5 to 85). The group of women who were greatly improved or cured had a mean of 17.5 cc of collagen injected, whereas those who were improved, unchanged, or worse had a mean of 39.5 cc injected (P = 0.002). Mean pretreatment SLPPs of women improved, greatly improved, or cured versus the women unchanged or worse were not significantly different (P = 0.015). The 35 women who were improved or cured had a significant increase in mean SLPP of 65.4 cm H2O (P = 0.001) compared to a mean change in SLPP of 14.7 cm H2O in those women who were unchanged or worse (P = 0.038).


CONCLUSIONS
GAX collagen injection for the treatment of stress urinary incontinence secondary to ISD appears to be safe, effective, and durable; hence, it should be considered the treatment of choice in appropriately selected female patients.
Richardson
T D
TD
University of Michigan Medical Center, Department of Surgery, Ann Arbor, USA.
Kennelly
M J
MJ
Faerber
G J
GJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003094:Collagen / Q000627:therapeutic use*; D003432:Cross-Linking Reagents / Q000627:therapeutic use*; D003558:Cystoscopy; D004724:Endoscopy; D005260:Female; D006801:Humans; D007267:Injections; D008875:Middle Aged; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000628:therapy*; D014563:Urodynamics / Q000502:physiology
D003432:Cross-Linking Reagents; C048470:glutaraldehyde-cross-linked collagen; D003094:Collagen