Evaluation of Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

NCT04140253 | Completed

• 1 other identifier: 24012019
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor muscle training in women who suffer from stress urinary incontinence

Conditions

Stress Urinary Incontinence in Women

Keywords

Stress urinary incontinence; Pelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

• Change in incontinence episode frequency

  The investigators will compare change in incontinence episode frequency in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone

  over 12 weeks of treatment

Secondary Outcomes (3)

• Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)

  over 12 weeks of treatment

• Change in Patient Global Impression of Improvement (PGI-I score)

  over 12 weeks of treatment

• Incidence of adverse events

  over 12 weeks of treatment

Study Arms (2)

Standard Duloxetine treatment

ACTIVE COMPARATOR

Peroral treatment with duloxetine at a dose of 40 mg twice a day

Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization

Standard Duloxetine treatment with PFMT

EXPERIMENTAL

Peroral treatment with duloxetine at a dose of 40 mg twice a day. Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.

Behavioral: Pelvic floor muscle training (PFMT) with lumbopelvic stabilization

Interventions

Pelvic floor muscle training (PFMT) with lumbopelvic stabilization BEHAVIORAL

Pelvic floor muscle training (PFMT) with lumbopelvic stabilization. 1. Educating of probands about anatomy, physiology, and pelvic floor muscles functions 2. Training of pelvic floor muscles in different position 3. Training of pelvic floor muscles with lumbopelvic stabilization Exercise 5 times a week for 20-30 minutes a day, after initial training with a physiotherapist.

Standard Duloxetine treatment; Standard Duloxetine treatment with PFMT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: woman with stress urinary incontinence
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman's willing to provide written informed consent
• Women over 18 years that experience uncomplicated stress urinary incontinence
• Score of the International Consultation on Urinary Incontinence Questionnaire ≥ 14 points
• Symptoms of urinary incontinence for at least 3 consecutive months
• Have at least seven urinary incontinence episodes per week
• Degree of pelvic organ prolapse ≤ 2 stage
• Willingness to accept the randomization process and fully participate in tests

You may not qualify if:

• Recent use of any pharmacologic agent used to treat symptoms of urinary incontinence in the past six months
• History of anti-incontinence surgery in the past 12 months
• Use of onabotulinumtoxinA for the treatment of urinary incontinence in the past 12 months
• History of pelvic prolapse repair or urethral surgery in the past 12 months
• History of pelvic floor muscle training in the past 12 months
• History of interstitial cystitis or bladder-related pain
• Chronic severe constipation
• Clinically significant renal or hepatic impairment
• Clinically significant heart impairment
• Pregnant woman, lactating, or actively trying to become pregnant
• Non-compliance with limitation of duloxetine treatment for mixed urinary incontinence
• Positive urinary tract infection
• Use of rehabilitation aids (pessary, urethral plugs, vaginal beads, etc.)
• Use of antidepressant therapy
• Insufficient understanding of pelvic floor exercises and/or omitting exercises

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava

Martin, 03601, Slovakia

Location

Related Publications (2)

• Hagovska M, Svihra J, Breza J Jr, Dubravicky J, Vargovcak M. A randomized, intervention parallel multicentre study to evaluate duloxetine and innovative pelvic floor muscle training in women with uncomplicated stress urinary incontinence-the DULOXING study. Int Urogynecol J. 2021 Jan;32(1):193-201. doi: 10.1007/s00192-020-04516-w. Epub 2020 Aug 27.

  PMID: 32852574 DERIVED

• Hagovska M, Svihra J. Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(6):e18834. doi: 10.1097/MD.0000000000018834.

  PMID: 32028393 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 25, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 10, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)