Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary Incontinence

NCT06673875 | Recruiting DMC

• 1 other identifier: Aniball inco
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The eim is to evaluate the clinical effectiveness of pelvic floor muscle training (PFMT) in conservative therapy in women with objective, urodynamic stress urinary incontinence using home exercise training with the medical vaginal device versus standard pelvic floor muscle training-exercises

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; physiotherapy of pelvic floor; conservative treatment

Outcome Measures

Primary Outcomes (1)

• International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-SF) questionnaire

  Assessment of pelvic floor muscle rehabilitation training to change the clinical severity of urinary incontinence using the questionnaire - International Consultation on Incontinence Questionnaire - urinary incontinence short form (ICIQ-UI SF - range 0 to 21) at at time of initial urogynecology examination / after 8 weaks of training / and after 4 months of training/ at the time of output urogynecology examination - in the group with home exercises using the medical device Aniball-inco ( 1st group) vs. exercise of the pelvic floor muscles after education by a physiotherapist (2nd group).

  baseline at time of initial urogynecology examination/ after 8 weeks/ and after 4 months at output urogynecology examination

Secondary Outcomes (2)

• objective urodynamics parameters

  baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination

• objective measured parameters of urine leakage.

  baseline at time of initial urogynecologic check visit/ after 4 months at time of output urogynecology examination

Other Outcomes (1)

• Ultrasound parameters

  baseline at time of urogynecologic check visit/ after 4 months at time of output urogynecology examination

Study Arms (2)

Aniball-inco

EXPERIMENTAL

training muscles with vaginal device to excercise of pelvic floor muscle.

Device: vaginal device Aniball INCO

RHB

ACTIVE COMPARATOR

training muscles without device to excercise of pelvic floor muscle.

Procedure: conservative treatment of stress urinary incontinence - pelvic floor muscle training

Interventions

conservative treatment of stress urinary incontinence - pelvic floor muscle training PROCEDURE

evaluation of pelvic floor muscle rehabilitation to change the clinical severity of urinary incontinence

RHB

vaginal device Aniball INCO DEVICE

the firt group - the pelvic floor muscle training with vaginal device Aniball INCO according manual after education by the urogynecologist, who is educated in pelvic floor dysfunction. the second group - the pelvic floor muscle training without vaginal device, the education was performed by certified physiotherapist trained in pelvic floor disorder.

Aniball-inco

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, Czech Republic, 62500, Czechia

RECRUITING

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

• Martina Szypulova

  Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Szypulova

CONTACT

+420 773882260; szypulova.martina@fnbrno.cz

Martin Huser

CONTACT

+420 532233843; huser.martin@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine, gynecologist, urogynecologist, principal investigator

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: November 5, 2024
• Study Start: March 23, 2023
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2025

Locations

CZ (1)