NCT05977231

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jan 2023Dec 2028

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

August 4, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

July 13, 2023

Last Update Submit

July 28, 2023

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (10)

  • 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)

Study Arms (6)

Bladder training (BT)

Data obtained before and after the training.

Procedure: BT

biofeedback-assisted pelvic floor muscle training (bPFMT)

Data obtained before and after the training.

Procedure: bPFMT

intra-vaginal electric stimulation (iVES)

Data obtained before and after the training.

Procedure: iVES

BT+bPFMT

Data obtained before and after the training.

Procedure: BT + bPFMT

BT+iVES

Data obtained before and after the training.

Procedure: BT + iVES

bPFMT+iVES

Data obtained before and after the training.

Procedure: bPFMT + iVES

Interventions

BTPROCEDURE

A program of BT (including exercise and muscle training)

Bladder training (BT)
bPFMTPROCEDURE

A bPFMT program at home

biofeedback-assisted pelvic floor muscle training (bPFMT)
iVESPROCEDURE

An iVES program at home

intra-vaginal electric stimulation (iVES)
BT + bPFMTPROCEDURE

Combination of BT and bPFMT

BT+bPFMT
BT + iVESPROCEDURE

Combination of BT and iVES

BT+iVES
bPFMT + iVESPROCEDURE

Combination of bPFMT and iVES

bPFMT+iVES

Eligibility Criteria

Age20 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Adult female patient diagnosed with urinary incontinence through clinical assessment
  • Diagnosed at Mackay Memorial Hospital and underwent non-surgical treatment and subsequent follow-up.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology

New Taipei City, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34453426BACKGROUND

  • 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.

    PMID: 31609735BACKGROUND

  • 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.

    PMID: 28681849BACKGROUND

  • 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.

    PMID: 30545535BACKGROUND

  • Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Effect of intra-vaginal electric stimulation on bladder compliance in stress urinary incontinence patients: the involvement of autonomic tone. Front Neurosci. 2024 Aug 7;18:1432616. doi: 10.3389/fnins.2024.1432616. eCollection 2024.

    PMID: 39170685DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hui-Hsuan Lau, M.D.

    Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan

    STUDY CHAIR

Central Study Contacts

Hui-Hsuan Lau, M.D.

CONTACT

+886-975-835928huihsuan1220@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Office of Research and Development staff

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 4, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2028

Last Updated

August 4, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

For we uncertain if this might violate personal information laws in our country.

Locations

TW(1)