Efficacy of Conservative Treatments for Urinary Incontinence in Women

Recruiting

• Conditions: Urinary Incontinence
• Interventions: Procedure: bPFMT; Procedure: BT + bPFMT; Procedure: BT + iVES; Procedure: BT; Procedure: bPFMT + iVES; Procedure: iVES

• Registration Number: NCT05977231
• Lead Sponsor: Mackay Medical College

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.

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-28
• Last Update Submitted: 2023-07-28
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Primary Completion: 2023-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
biofeedback-assisted pelvic floor muscle training (bPFMT)	bPFMT	Data obtained before and after the training.
BT+bPFMT	BT + bPFMT	Data obtained before and after the training.
BT+iVES	BT + iVES	Data obtained before and after the training.
Bladder training (BT)	BT	Data obtained before and after the training.
bPFMT+iVES	bPFMT + iVES	Data obtained before and after the training.
intra-vaginal electric stimulation (iVES)	iVES	Data obtained before and after the training.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology; 🇨🇳 New Taipei City, Taiwan