Efficacy of Conservative Treatments for Urinary Incontinence in Women

Official title

Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence

Overview

To conduct a retrospective study to examine the effect of these conservative treatments to the symptoms and quality of life of patients with urinary incontinence. The investigators will use both subjective and objective assessment parameters, such as self-report symptoms, bladder diary, pad test and urodynamic study to access the improvement.

Detailed description

Urinary incontinence is a common problem among women. The main types include stress incontinence, urge incontinence, and overflow incontinence. Other underlying pathology, such as cancer or neurologic disease can also cause urinary incontinence. To limit the medical expenses and possible complications of surgical treatment, the current treatment guidelines recommend conservative treatment as the first choice. According to American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) guidelines, the first-line treatment for non-neurologic overactive bladder should be behavioral therapy, such as bladder training, water restriction, and pelvic floor muscle training, physiological feedback, pessary, etc. Bladder training aims to increase the time interval between voids, and to increase the bladder capacity by self-adjusted schedules. Pelvic floor muscle training strengthens the pelvic floor muscles to provide urethral support to prevent urine leakage and suppress urgency. There is strong evidence that pelvic floor muscle training is beneficial for stress urinary incontinence.

The second-line treatment is medication, including anticholinergic drugs and ß3 adrenoceptor-acting agents. Anticholinergic drugs can reduce bladder detrusor contraction, and ß3 adrenoceptor-acting agents can relax the detrusor and increase bladder capacity.

Interventions

• Procedure BT
  A program of BT (including exercise and muscle training)
• Procedure bPFMT
  A bPFMT program at home
• Procedure iVES
  An iVES program at home
• Procedure BT + bPFMT
  Combination of BT and bPFMT
• Procedure BT + iVES
  Combination of BT and iVES
• Procedure bPFMT + iVES
  Combination of bPFMT and iVES

Primary outcome measures

• Urodynamic study (intravesical pressure) [Time frame: form the baseline to the post-treatment measurement (about 6 month post)]
• Urodynamic study (abdominal pressure) [Time frame: form the baseline to the post-treatment measurement (about 6 month post)]
• Urodynamic study (detrusor pressure) [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]
• Urodynamic study (Infused volume) [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]
• Urodynamic study (voided volume) [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]
• Pad test [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]
• Bladder diary (voiding frequency) [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]
• Bladder diary (voiding volume) [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]
• Questionaire (UDI-6) [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]
• Questionaire (IIQ-7) [Time frame: from the baseline to the post-treatment measurement (about 6 month post)]

Eligibility criteria

Inclusion criteria

• Adult female patient diagnosed with urinary incontinence through clinical assessment
• Diagnosed at Mackay Memorial Hospital and underwent non-surgical treatment and subsequent follow-up.

Exclusion criteria

• Choosing invasive or surgical treatment options (such as bladder botulinum toxin injection, urethral sling surgery).
• Unable to comply with regular follow-up for at least one year.
• Pregnant women
• Patients with a history of neuromuscular disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Taiwan · 1 center

• Department of Obstetrics and Gynecology — New Taipei City

Publications

• Denisenko AA, Clark CB, D'Amico M, Murphy AM. Evaluation and management of female urinary incontinence. Can J Urol. 2021 Aug;28(S2):27-32. PMID 34453426
• Wallace SL, Miller LD, Mishra K. Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. Curr Opin Obstet Gynecol. 2019 Dec;31(6):485-493. doi: 10.1097/GCO.0000000000000584. PMID 31609735
• Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42. PMID 28681849
• Lin HY, Tsai HW, Tsui KH, An YF, Lo CC, Lin ZH, Liou WS, Wang PH. The short-term outcome of laser in the management of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction. Taiwan J Obstet Gynecol. 2018 Dec;57(6):825-829. doi: 10.1016/j.tjog.2018.10.010. PMID 30545535
• Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Effect of intra-vaginal electric stimulation on bladder compliance in stress urinary incontinence patients: the involvement of autonomic tone. Front Neurosci. 2024 Aug 7;18:1432616. doi: 10.3389/fnins.2024.1432616. eCollection 2024. PMID 39170685

Identifiers

NCT: NCT05977231 · 23MMHIS058e

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗