Hypertonic Saline Injection For Urinary Incontinence

Status Completed

Clinical Trial Summary

The investigators aimed to evaluate the effectiveness and safety of periurethral hypertonic saline (10% NaCl) injection for the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI) in women.

Clinical Trial Description

This single-center prospective pre-post interventional study was conducted between January 2014 and April 2018 with 65 women (44 SUI, 21 MUI). Quality of life was evaluated with the Incontinence Quality of Life Scale (I-QoL) and the lower urinary tract symptoms of women were evaluated with the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Incontinence status was assessed via the Stamey Incontinence Grade scale. Patients with MUI also were evaluated using the Urinary Distress Inventory-6 (UDI-6). The need for additional treatment (re-injection, other surgical approaches, etc.) was recorded. Participants were followed up to 24 months after intervention. All outcomes of interest and complications were evaluated/recorded at six preplanned visits (postoperative 1st, 3rd, 6th, 12th, 18th, 24th months). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04812574
Study type	Interventional
Source	Turgut Ozal University
Contact
Status	Completed
Phase	Phase 3
Start date	January 1, 2014
Completion date	June 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02867748` - TVT-ABBREVO Versus SERASIS for the Treatment of Female Urinary Stress Incontinence: 1 Year Outcomes of a Comparative Study With 2 Trans-obturator Sub Mid Urethral Slings	N/A
Recruiting	`NCT02617797` - Radiofrequency in the Female Stress Urinary Incontinence	N/A
Active, not recruiting	`NCT02538991` - TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence	N/A
Completed	`NCT02480231` - Mid-Urethral Sling Tensioning Trial	N/A
Terminated	`NCT02591381` - Transcorporal Versus Standard Artificial Urinary Sphincter Placement	N/A
Completed	`NCT00984958` - Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure	N/A
Completed	`NCT00190567` - Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence	Phase 2
Completed	`NCT02423486` - The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback	N/A
Completed	`NCT01754558` - One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence	N/A
Recruiting	`NCT00136071` - Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) Versus Transobturator Tape-Mentor (TOT) in the Management of Urodynamic Stress Urinary Incontinence	N/A
Completed	`NCT00190619` - Efficacy and Safety of Duloxetine	Phase 3
Completed	`NCT04288648` - Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
Active, not recruiting	`NCT05182632` - Tele-rehabilitation Group Program for Urinary Incontinence in Older Women	N/A
Completed	`NCT03672461` - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women	N/A
Completed	`NCT02407145` - Safety and Efficacy of PVDF (DynaMesh®-SIS Soft) Retropubic Midurethral Slings in Stress Urinary Incontinence in Women
Completed	`NCT01784172` - Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial	Phase 2
Recruiting	`NCT02935803` - A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients	N/A
Active, not recruiting	`NCT02039830` - Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women	N/A
Recruiting	`NCT04817839` - Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures	N/A
Completed	`NCT03439527` - Multisystem Cell Therapy for Improvement of Urinary Continence	Phase 1