Autologous muscle precursor cell injection into the bladder neck improves the symptoms of stress urinary incontinence in adult females.

BACKGROUND

The transplantation of autologous muscle precursor cells (MPCs) is effective in the regeneration of muscle in multiple pathologies. This phase I clinical trial sought to use MPCs to treat stress urinary incontinence (UI).

METHODS

Female patients with either stress urinary incontinence (SUI) or congenitally acquired UI had thigh muscle biopsies prior to MPC expansion and processing. The MPCs were injected directly into the bladder neck. Symptoms were measured using pad weight tests (1-h and 3-day), baseline questionnaires (Urogenital Distress Inventory [UDI-6], Incontinence Impact Questionnaire [IIQ-7]), and self-reported accident frequencies.

RESULTS

Ten women aged 16-75 were included. For the 8 SUI subjects, there was a reduction in pad weight between pre- and post-treatment for the 1-h (P < .0001) and 3-day (P = .0076) pad tests after adjusting for age, gravida, and body mass index. The reduction was observed by the 6-week post-treatment visit and remained relatively constant thereafter. There was no evidence of a difference among the 4 post-treatment pad weights for either the 1-h (P > .05) or the 3-day (P > .05) pad tests. Similarly, there was evidence of a reduction from pre- to post-treatment in UDI-6 (P = .0034), IIQ-7 (P = .0455), and the number of self-reported accidents (P = .0656). There was no evidence of regression during the post-treatment visits for UDI-6 (P > .5), IIQ-7 (P > .25), and the number of self-reported accidents (P > .25). The 2 subjects with congenital incontinence did not improve (P > .05).

CONCLUSIONS

Autologous thigh muscle-derived MPC injection into the bladder neck is a safe and well-tolerated treatment for acquired stress UI in adult women.