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

NCT05778552 | Recruiting

• 1 other identifier: 2022-10-004A
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Disorders; Pelvic Organ Prolapse; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

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

Interventions

Home-based pelvic muscle training devices or traditional PFMT at hospital DEVICE

Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital

Home-based pelvic muscle training devices group; Traditional pelvic muscle training devices group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders; Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Huann-Cheng Horng

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huann-Cheng Horng

CONTACT

886-(2) 2875-7826; hchorng@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 21, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)