Clinical trial NCT04812574: Hypertonic Saline Injection For Urinary Incontinence
Official title: Periurethral Hypertonic Saline (10%) Injection for Female Stress Urinary Incontinence and Stress-Predominant Mixed Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Stress Incontinence
Keywords: Female
Stress Urinary Incontinence
Stress-Predominant Mixed Incontinence
Hypertonic Saline Injection
Therapy
Lead sponsor: Turgut Ozal University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2021-03-23
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center prospective before-after (pre-post) interventional study, in which the effectiveness and safety of periurethral hypertonic saline injection were evaluated in female stress urinary incontinence and stress-predominant mixed urinary incontinence patients.
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Stamey Incontinence Grade at 24 months
timeFrame: Change from baseline at 24 months
measure: Change in the Urinary Distress Inventory-6 (UDI-6) scores at 1 month
timeFrame: Change from baseline at 1 month
measure: Change in the Urinary Distress Inventory-6 (UDI-6) scores at 3 months
timeFrame: Change from baseline at 3 months
measure: Change in the Urinary Distress Inventory-6 (UDI-6) scores at 6 months
timeFrame: Change from baseline at 6 months
measure: Change in the Urinary Distress Inventory-6 (UDI-6) at 12 months
timeFrame: Change from baseline at 12 months
measure: Change in the Urinary Distress Inventory-6 (UDI-6) scores at 18 months
timeFrame: Change from baseline 18 months
measure: Change in the Urinary Distress Inventory-6 (UDI-6) scores at 24 months
timeFrame: Change from baseline 24 months
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month
timeFrame: Change from baseline at 1 month
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 months
timeFrame: Change from baseline at 3 months
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 months
timeFrame: Change from baseline at 6 months
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 12 months
timeFrame: Change from baseline at 12 months
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 18 months
timeFrame: Change from baseline at 18 months
measure: Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 24 months
timeFrame: Change from baseline at 24 months
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month
timeFrame: Change from baseline at 1 month
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months
timeFrame: Change from baseline at 3 months
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months
timeFrame: Change from baseline at 6 months
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 12 months
timeFrame: Change from baseline at 12 months
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 18 months
timeFrame: Change from baseline at 18 months
measure: Change in the Incontinence Quality of Life Scale (I-QOL) scores at 24 months
timeFrame: Change from baseline at 24 months
measure: Need for addtional treatment within the 1st month
timeFrame: Within the 1st month
measure: Need for addtional treatment within 3 months after internvention.
timeFrame: Within the 3 months after internvention.
measure: Need for addtional treatment within 6 months after internvention.
timeFrame: Within the 6 months after internvention.
measure: Need for addtional treatment within 12 months after internvention.
timeFrame: Within the 12 months after internvention.
measure: Need for addtional treatment within 18 months after internvention.
timeFrame: Within the 18 months after internvention.
measure: Need for addtional treatment within 24 months after internvention.
timeFrame: Within the 24 months after internvention.
measure: Presence of complication within 24 months after intervention
timeFrame: Within 24 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal University
city: Malatya
country: Turkey
facility: İnonu University
Study officials:
affiliation: Turgut Ozal University
name: İbrahim N Tahtali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Irwin GM. Urinary Incontinence. Prim Care. 2019 Jun;46(2):233-242. doi: 10.1016/j.pop.2019.02.004. Epub 2019 Apr 5.
citation: Muth CC. Urinary Incontinence in Women. JAMA. 2017 Oct 24;318(16):1622. doi: 10.1001/jama.2017.15571. No abstract available.