The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training

The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training : Prospective Study

When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence; Pelvic Floor Disorders
• Intervention / Treatment: Device: Home-based pelvic muscle training devices or traditional PFMT at hospital

Detailed Description

The investigators will enroll participants with SUI or POP and allocate them into either the home-based pelvic floor muscle training (PFMT) group or traditional PFMT group. Participant satisfaction will be evaluated using a questionnaire score.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Huann-Cheng Horng; Phone Number: 886-(2) 2875-7826; Email: hchorng@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Huann-Cheng Horng, MD, PhD; Phone Number: 886-(2) 2875-7826; Email: hchorng@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with SUI and Pelvic organ prolapse could be enrolled for study

Description

Inclusion Criteria:

• Age > 18-year-old, non-pregnancy, SUI, bladder capacity > 300ml, RU<150ml, pelvic organ prolapse

Exclusion Criteria:

• recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Home-based pelvic muscle training devices group; Patients underwent pelvic muscle training by home-based device and at home.	Device: Home-based pelvic muscle training devices or traditional PFMT at hospital; Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital
Traditional pelvic muscle training devices group; Patients underwent traditional pelvic muscle training at hospital	Device: Home-based pelvic muscle training devices or traditional PFMT at hospital; Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The satisfication of pelvic muscle training (UDI-6)	The total score ranges from 0 to 18, with a higher score indicating that the patient experiences a greater degree of urinary distress.	up to 2 years
The satisfication of pelvic muscle training (ICIQ-SF)	The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.	up to 2 years
The satisfication of pelvic muscle training (IIQ-7)	The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.	up to 2 years
The satisfication of pelvic muscle training (POPDI-6)	POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms	up to 2 years
The satisfication of pelvic muscle training (PISQ-IR)	The PISQ-IR is a validated questionnaire in research for assessment of female sexual function. A higher score indicates a greater negative impact on sexual function.	up to 2 years

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Huann-Cheng Horng, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Pregnancy Complications; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Urinary Incontinence, Stress; Pelvic Floor Disorders
• Other Study ID Numbers: 2022-10-004A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No