A Novel Biofeedback for Urinary Incontinence in Women

NCT04638348 | Completed

• 1 other identifier: P0033900
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

A three-armed randomized pilot trial will be conducted with 51 women having stress urinary incontinence, to evaluate the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth. Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device. Study outcome measures include, feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.

Conditions

Stress Urinary Incontinence

Keywords

Biofeedback

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Number of participants recruited/screened in a week, the time taken for recruitment of participants, and reasons for declining to participate will be recorded.

  At the end of recruitment period

• Adherence

  The 0-10-point scale of the reliable tool (Cronbach's α=0.7059) developed to monitor long-term adherence to PFMT in women with UI (that quantifies adherence to home exercise as "low," "moderate," or "high") will be used to evaluate adherence to PFMT with and without the biofeedback device

  Post-intervention at 6 months

• Retention rate

  This will be calculated as the percentage of participants who completed assessments at 1, 3, and 6 months.

  Post-treatment at 1, 3 and 6 months

Secondary Outcomes (3)

• International Consultation on Incontinence Questionnaire-short form

  Baseline (pre-intervention), post-treatment at 1, 3 and 6 months

• one-hour pad test with stress test

  Baseline (pre-intervention), post-treatment at 1, 3 and 6 months

• Modified Oxford scale

  Baseline (pre-intervention), post-treatment at 1, 3 and 6 months

Study Arms (3)

New Biofeedback

EXPERIMENTAL

Women allocated to the new biofeedback group will be instructed to attach the biofeedback device to their underpants and then perform pelvic floor muscle training.

Device: New Biofeedback

Conventional Biofeedback

ACTIVE COMPARATOR

Women allocated to the conventional biofeedback group will undergo pelvic floor muscle training with the conventional biofeedback probe inserted in the vagina

Device: New Biofeedback

Control group

ACTIVE COMPARATOR

The control group will perform pelvic floor muscle training without any biofeedback device.

Device: New Biofeedback

Interventions

New Biofeedback DEVICE

Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.

Also known as: Conventional Biofeedback

Control group; Conventional Biofeedback; New Biofeedback

Eligibility Criteria

• Age: 35 Years - 60 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women in the age group of 35 to 60 years of age;
• non-pregnant;
• having stress urinary incontinence;
• experiencing mild to moderate urinary incontinence (obtaining a score of ≤ 12 on the short-form of the International Consultation on Incontinence Questionnaire (ICIQ-sf); and
• obtaining a mini-mental state examination (MMSE) score of ≥ 24.

You may not qualify if:

• being in the postpartum stage of \< 6 months;
• having severe pelvic organ prolapse (stages 3 and 4 on the Baden and Walker grading tool);
• women taking any medications that might cause urine retention;
• women having complicated UI due to radiation to pelvic region;
• obesity with a body mass index ≥ 30;
• women with incontinence secondary to other medical conditions or previous surgeries;
• women with severe psychological problems impairing participation in the study; and
• women having mixed or urge UI.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Kwong Wah Hospital: collaborator

Study Sites (1)

Kwong Wah Hospital

Kowloon, Hong Kong

Location

Related Publications (1)

• Kannan P, Cheing GLY, Fung BKY, Li J, Leung WC, Chung RCK, Cheung TW, Lam LF, Lee WY, Wong WC, Wong WH, Tang PYG, Chan PKL. Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial. Contemp Clin Trials. 2022 Dec;123:106991. doi: 10.1016/j.cct.2022.106991. Epub 2022 Nov 2.

  PMID: 36332826 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Priya Kannan, PhD

  The Hong Kong Polytechnic Unviersity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: February 1, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)