Efficacy of Conservative Treatments for Urinary Incontinence in Women

Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Hui-Hsuan Lau, M.D.; Phone Number: +886-975-835928; Email: huihsuan1220@gmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Recruiting
    • Department of Obstetrics and Gynecology
    • Contact: Hui-Hsuan Lau, PhD; Phone Number: +886 975-835928; Email: huihsuan1220@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Diagnosed at Mackay Memorial Hospital, the adult female patient was clinically assessed and diagnosed with urinary incontinence. Non-surgical treatments were administered, followed by subsequent monitoring and follow-up.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urodynamic study (intravesical pressure)	intravesical pressure (cmH2O)	form the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (abdominal pressure)	abdominal pressure (cmH2O)	form the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (detrusor pressure)	detrusor pressure (cmH2O)	from the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (Infused volume)	infused volume (ml)	from the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (voided volume)	voided volume (ml)	from the baseline to the post-treatment measurement (about 6 month post)
Pad test	The weight of Pad (g) before and after testing	from the baseline to the post-treatment measurement (about 6 month post)
Bladder diary (voiding frequency)	the daily voiding frequency (times)	from the baseline to the post-treatment measurement (about 6 month post)
Bladder diary (voiding volume)	the daily voiding volume (ml)	from the baseline to the post-treatment measurement (about 6 month post)
Questionaire (UDI-6)	The urogenital distress inventory-6 (UDI-6)	from the baseline to the post-treatment measurement (about 6 month post)
Questionaire (IIQ-7)	incontinence impact questionnaire-7 (IIQ-7)	from the baseline to the post-treatment measurement (about 6 month post)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Nat Rev Dis Primers. 2017 Nov 16;3:17097.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 23MMHIS058e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For we uncertain if this might violate personal information laws in our country.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No