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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04812574
Other study ID # 6175679-514.04.01-E.28641
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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