Hypertonic Saline Injection For Urinary Incontinence

Urinary Stress Incontinence Clinical Trial

Official title:

Periurethral Hypertonic Saline (10%) Injection for Female Stress Urinary Incontinence and Stress-Predominant Mixed Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812574
• Other study ID #: 6175679-514.04.01-E.28641
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2014
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2021
• Source: Turgut Ozal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 1, 2020
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Procedure:
• Periurethral injection
Patients were in the lithotomy position for the procedure. After preparation, topical Lidocaine gel was instilled around the meatus and a 16 F probe was attached. The catheter balloon was inflated to localize the bladder neck and to ensure that injections were performed in the correct anatomical plane. Hypertonic saline (10% NaCl) was injected to the alignment of the urethral meatus in the order of 3-6-9-12 hours of the clock (5 cc to each site, totaling 20 cc). Syringes with 27 Gauge (0.40 mm) outer diameter were used to ensure controlled injection. Since the female urethra is about 4 cm in length, the needle was advanced about 3 cm. Due to the possibility of significant pain with hypertonic saline, 2 cc of Lidocaine hydrochloride was added into the solution.

Drug:
• Hypertonic (10%) saline
Periurethral hypertonic saline (10%)

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya
Turkey	Turgut Ozal University	Malatya

Sponsors (2)

Lead Sponsor	Collaborator
Turgut Ozal University	Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Irwin GM. Urinary Incontinence. Prim Care. 2019 Jun;46(2):233-242. doi: 10.1016/j.pop.2019.02.004. Epub 2019 Apr 5. Review. — View Citation

Muth CC. Urinary Incontinence in Women. JAMA. 2017 Oct 24;318(16):1622. doi: 10.1001/jama.2017.15571. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Stamey Incontinence Grade at 24 months	All patients (SUI and MUI) were evaluated as follows: Grade 0: No incontinence; Grade 1: Incontinence with coughing or straining; Grade 2: Incontinence with change in position or walking; Grade 3: Total incontinence at all times	Change from baseline at 24 months
Primary	Change in the Urinary Distress Inventory-6 (UDI-6) scores at 1 month	Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.	Change from baseline at 1 month
Primary	Change in the Urinary Distress Inventory-6 (UDI-6) scores at 3 months	Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.	Change from baseline at 3 months
Primary	Change in the Urinary Distress Inventory-6 (UDI-6) scores at 6 months	Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.	Change from baseline at 6 months
Primary	Change in the Urinary Distress Inventory-6 (UDI-6) at 12 months	Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.	Change from baseline at 12 months
Primary	Change in the Urinary Distress Inventory-6 (UDI-6) scores at 18 months	Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.	Change from baseline 18 months
Primary	Change in the Urinary Distress Inventory-6 (UDI-6) scores at 24 months	Only MUI patients were evaluated with UDI-6 scale. UDI-6 is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.	Change from baseline 24 months
Primary	Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 1 month	All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.	Change from baseline at 1 month
Primary	Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 3 months	All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.	Change from baseline at 3 months
Primary	Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 6 months	All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.	Change from baseline at 6 months
Primary	Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 12 months	All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.	Change from baseline at 12 months
Primary	Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 18 months	All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.	Change from baseline at 18 months
Primary	Change in the Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) scores at 24 months	All patients (SUI and MUI) were evaluated with the ICIQ-FLUTS which is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life of the patients.	Change from baseline at 24 months
Primary	Change in the Incontinence Quality of Life Scale (I-QOL) scores at 1 month	All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).	Change from baseline at 1 month
Primary	Change in the Incontinence Quality of Life Scale (I-QOL) scores at 3 months	All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).	Change from baseline at 3 months
Primary	Change in the Incontinence Quality of Life Scale (I-QOL) scores at 6 months	All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).	Change from baseline at 6 months
Primary	Change in the Incontinence Quality of Life Scale (I-QOL) scores at 12 months	All patients (SUI and MUI) were evaluated with the I-QOL which 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).	Change from baseline at 12 months
Primary	Change in the Incontinence Quality of Life Scale (I-QOL) scores at 18 months	All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).	Change from baseline at 18 months
Primary	Change in the Incontinence Quality of Life Scale (I-QOL) scores at 24 months	All patients (SUI and MUI) were evaluated with the I-QOL which has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarassment (5 items).	Change from baseline at 24 months
Primary	Need for addtional treatment within the 1st month	Patients who are needed to treat with re-injection or other surgercal approaches.	Within the 1st month
Primary	Need for addtional treatment within 3 months after internvention.	Patients who are needed to treat with re-injection or other surgercal approaches.	Within the 3 months after internvention.
Primary	Need for addtional treatment within 6 months after internvention.	Patients who are needed to treat with re-injection or other surgercal approaches.	Within the 6 months after internvention.
Primary	Need for addtional treatment within 12 months after internvention.	Patients who are needed to treat with re-injection or other surgercal approaches.	Within the 12 months after internvention.
Primary	Need for addtional treatment within 18 months after internvention.	Patients who are needed to treat with re-injection or other surgercal approaches.	Within the 18 months after internvention.
Primary	Need for addtional treatment within 24 months after internvention.	Patients who are needed to treat with re-injection or other surgercal approaches.	Within the 24 months after internvention.
Primary	Presence of complication within 24 months after intervention	Presence of complication such as infection at injection site, urinary tract infection, hematuria, persistent pain, de novo urge incontinence) in all patients.	Within 24 months after intervention