Efficacy of Conservative Treatments for Urinary Incontinence in Women

Urinary Incontinence Clinical Trial

Official title:

Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977231
• Other study ID #: 23MMHIS058e
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: July 2023
• Source: Mackay Medical College
• Contact: Hui-Hsuan Lau, M.D.
• Phone: +886-975-835928
• Email: huihsuan1220[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Medical College

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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