Biofeedback-Assisted pelvic floor muscle training combined with a short-duration drug regimen is safe and effective in women with overactive bladder: A randomized controlled trial

Eur J Obstet Gynecol Reprod Biol. 2024 Oct:301:166-172. doi: 10.1016/j.ejogrb.2024.07.050. Epub 2024 Aug 2.

Abstract

Objective: We hypothesized that combination therapy would provide a synergistic effect to improve treatment outcomes for overactive bladder (OAB), thus enhancing the motivation for continuous exercise, and that it would be associated with fewer adverse events than monotherapy. Therefore, we investigated whether biofeedback-assisted pelvic floor muscle training (PFMT), drug therapy, or a combination of both would be more effective in improving the symptoms of OAB.

Study design: This randomized controlled trial included women diagnosed with OAB. Group 1 received biofeedback-assisted pelvic muscle floor training (PFMT) for 12 weeks; group 2 took 5 mg of solifenacin/day for 12 weeks; and group 3 received 5 mg of solifenacin/day in combination with biofeedback-assisted PFMT during the first 4 weeks and biofeedback-assisted PFMT for another 8 weeks. All participants had 5 follow-up visits. The primary outcomes were objective improvement of OAB symptoms and quality of life. The secondary outcomes were treatment-related adverse events, subjective improvement of OAB symptoms, and electromyographic activity of pelvic floor muscle (PFM) contraction.

Results: All participants reported significant improvement of OAB symptoms and quality of life. Participants in group 2 experienced more pronounced adverse events than those in group 3. Intervention duration was positively associated with subjective improvement in OAB symptoms in groups 2 and 3. Drug-related adverse events, including dry mouth, myalgia, and restlessness, had a negative impact on the subjective improvement of OAB symptoms in group 2. In group 1, exercise adherence was positively correlated with subjective improvement of OAB symptoms, whereas in group 3, PFM contraction and biofeedback effect were positively correlated with symptom improvement.

Conclusion: Combination therapy is efficacious in treating women with OAB.

Keywords: Bio-assisted surface electromyographic program; Combined therapy; Drug; Overactive bladder; Pelvic floor muscle training.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Biofeedback, Psychology* / methods
  • Combined Modality Therapy
  • Exercise Therapy* / methods
  • Female
  • Humans
  • Middle Aged
  • Pelvic Floor* / physiopathology
  • Quality of Life
  • Solifenacin Succinate* / administration & dosage
  • Solifenacin Succinate* / therapeutic use
  • Treatment Outcome
  • Urinary Bladder, Overactive* / drug therapy
  • Urinary Bladder, Overactive* / therapy

Substances

  • Solifenacin Succinate