Clinical trial NCT05977231: Efficacy of Conservative Treatments for Urinary Incontinence in Women
Official title: Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Incontinence
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Urodynamic study (intravesical pressure)
timeFrame: form the baseline to the post-treatment measurement (about 6 month post)
measure: Urodynamic study (abdominal pressure)
timeFrame: form the baseline to the post-treatment measurement (about 6 month post)
measure: Urodynamic study (detrusor pressure)
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
measure: Urodynamic study (Infused volume)
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
measure: Urodynamic study (voided volume)
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
measure: Pad test
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
measure: Bladder diary (voiding frequency)
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
measure: Bladder diary (voiding volume)
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
measure: Questionaire (UDI-6)
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
measure: Questionaire (IIQ-7)
timeFrame: from the baseline to the post-treatment measurement (about 6 month post)
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Obstetrics and Gynecology
Study officials:
affiliation: Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
name: Hui-Hsuan Lau, M.D.
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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.