Efficacy of Conservative Treatments for Urinary Incontinence in Women

Sponsor
Mackay Medical College (Other)
Overall Status
Recruiting
CT.gov ID
NCT05977231
Collaborator
(none)
60
1
72
0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: BT
  • Procedure: bPFMT
  • Procedure: iVES
  • Procedure: BT + bPFMT
  • Procedure: BT + iVES
  • Procedure: bPFMT + iVES

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Bladder training (BT)

Data obtained before and after the training.

Procedure: BT
A program of BT (including exercise and muscle training)

biofeedback-assisted pelvic floor muscle training (bPFMT)

Data obtained before and after the training.

Procedure: bPFMT
A bPFMT program at home

intra-vaginal electric stimulation (iVES)

Data obtained before and after the training.

Procedure: iVES
An iVES program at home

BT+bPFMT

Data obtained before and after the training.

Procedure: BT + bPFMT
Combination of BT and bPFMT

BT+iVES

Data obtained before and after the training.

Procedure: BT + iVES
Combination of BT and iVES

bPFMT+iVES

Data obtained before and after the training.

Procedure: bPFMT + iVES
Combination of bPFMT and iVES

Outcome Measures

Primary Outcome Measures

  1. Urodynamic study (intravesical pressure) [form the baseline to the post-treatment measurement (about 6 month post)]

    intravesical pressure (cmH2O)

  2. Urodynamic study (abdominal pressure) [form the baseline to the post-treatment measurement (about 6 month post)]

    abdominal pressure (cmH2O)

  3. Urodynamic study (detrusor pressure) [from the baseline to the post-treatment measurement (about 6 month post)]

    detrusor pressure (cmH2O)

  4. Urodynamic study (Infused volume) [from the baseline to the post-treatment measurement (about 6 month post)]

    infused volume (ml)

  5. Urodynamic study (voided volume) [from the baseline to the post-treatment measurement (about 6 month post)]

    voided volume (ml)

  6. Pad test [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) [from the baseline to the post-treatment measurement (about 6 month post)]

    the daily voiding frequency (times)

  8. Bladder diary (voiding volume) [from the baseline to the post-treatment measurement (about 6 month post)]

    the daily voiding volume (ml)

  9. Questionaire (UDI-6) [from the baseline to the post-treatment measurement (about 6 month post)]

    The urogenital distress inventory-6 (UDI-6)

  10. Questionaire (IIQ-7) [from the baseline to the post-treatment measurement (about 6 month post)]

    incontinence impact questionnaire-7 (IIQ-7)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Obstetrics and Gynecology New Taipei City Taiwan

Sponsors and Collaborators

  • Mackay Medical College

Investigators

  • Study Chair: Hui-Hsuan Lau, M.D., Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chin-Tsung Shen, The Office of Research and Development staff, Mackay Medical College
ClinicalTrials.gov Identifier:
NCT05977231
Other Study ID Numbers:
  • 23MMHIS058e
First Posted:
Aug 4, 2023
Last Update Posted:
Aug 4, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2023