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NCT Number: NCT05977231

Efficacy of Conservative Treatments for Urinary Incontinence in Women

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology

New Taipei City, Taiwan

Location status: Recruiting

Location contact

Hui-Hsuan Lau, PhD

CONTACT

[email protected]

+886 975-835928

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BT

Procedure

A program of BT (including exercise and muscle training)

bPFMT

Procedure

A bPFMT program at home

iVES

Procedure

An iVES program at home

BT + bPFMT

Procedure

Combination of BT and bPFMT

BT + iVES

Procedure

Combination of BT and iVES

bPFMT + iVES

Procedure

Combination of bPFMT and iVES

Primary outcomes

  1. Urodynamic study (intravesical pressure)

    Time frame: form the baseline to the post-treatment measurement (about 6 month post)

    intravesical pressure (cmH2O)

  2. Urodynamic study (abdominal pressure)

    Time frame: form the baseline to the post-treatment measurement (about 6 month post)

    abdominal pressure (cmH2O)

  3. Urodynamic study (detrusor pressure)

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    detrusor pressure (cmH2O)

  4. Urodynamic study (Infused volume)

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    infused volume (ml)

  5. Urodynamic study (voided volume)

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    voided volume (ml)

  6. Pad test

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    The weight of Pad (g) before and after testing

  7. Bladder diary (voiding frequency)

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    the daily voiding frequency (times)

  8. Bladder diary (voiding volume)

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    the daily voiding volume (ml)

  9. Questionaire (UDI-6)

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    The urogenital distress inventory-6 (UDI-6)

  10. Questionaire (IIQ-7)

    Time frame: from the baseline to the post-treatment measurement (about 6 month post)

    incontinence impact questionnaire-7 (IIQ-7)

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Hsuan Lau, M.D.

CONTACT

[email protected]

+886-975-835928

Sponsors and collaborators

Lead sponsor

Mackay Medical College

Other

Registry information

Official study title

Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence

Important dates

Study start
2023
Primary completion
2023
Study completion
2028
First posted
Aug 4, 2023
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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