Hypertonic Saline Injection For Urinary Incontinence

Turgut Ozal University

Status and phase: Completed; Phase 3

Conditions: Urinary Stress Incontinence

Treatments: Drug: Hypertonic (10%) saline; Procedure: Periurethral injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04812574

6175679-514.04.01-E.28641

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The patients who described Stress Urinary Incontinence or Mixed Urinary Incontinence, those who had incontinence during the Valsalva maneuver, patients with positive Marshal-Marchetti test, and those with post-void residual urine volume ≤100 mL were included in the study.

Exclusion criteria

Temporary urinary incontinence, delirium, urinary tract infection, urethritis, pure urge incontinence, nocturnal enuresis, decreased bladder compliance and detrusor contraction in the urodynamic study, leakage of urine with low bladder pressure, psychiatric conditions (severe depression and anxiety), body mass index (BMI) >35 kg/m2, and using drugs that may influence bladder storage or emptying

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Hypertonic Saline (10%) Injection

Experimental group

Description:

Periurethral hypertonic saline (10%) injection was performed in female patients with Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

Treatment:

Procedure: Periurethral injection

Drug: Hypertonic (10%) saline