Overactive BladderNCT06024005
Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder
A study testing Oral Solifenacin 5mg and Transcutaneous Posterior Tibial Nerve Stimulation (TTNS) in people with Overactive Bladder and Overactive Bladder Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Overactive bladder (OAB) syndrome is a symptom complex characterized by sudden urgency, frequent urination, nocturia, and urge incontinence without any identifiable organic cause, significantly impacting the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome
- What is being tested?
- Oral Solifenacin 5mg and Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2023to 24 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with a diagnosis of OAB and unresponsive to first-line treatment,
- Absence of genito-urinary system malformations that may cause pollacullaire,
- Volunteering to participate in the research,
- To be literate in Turkish
Who cannot join
- Having a urinary tract infection,
- Having pelvic organ prolapse greater than stage 2,
- To be diagnosed with stress type urinary incontinence,
- Having narrow-angle glaucoma, myasthenia gravis and severe gastro-intestinal diseases,
- Patients undergoing hemodialysis,
- Having severe liver or kidney failure,
Show all 11Show fewer
- Pregnancy,
- Having a pacemaker
- Presence of epilepsy,
- The presence of built-in metal in the ankle
- Open ankle wound
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, School of Medicine, Department of Obstetrics and Gynecology
Izmir, 35100
About this study
Official title: A Prospective Randomized Controlled Trial: Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Oral Solifenacin Treatments' Effects in Women Between 18-80 Years Old Who Have Overactive Bladder
Overactive bladder (OAB) syndrome is a symptom complex characterized by sudden urgency, frequent urination, nocturia, and urge incontinence without any identifiable organic cause, significantly impacting the quality of life. One of the most prominent symptoms is the urgency to urinate accompanied by a sudden sensation of bladder fullness.
There are various treatment options available for managing OAB, including conservative therapy, pharmacotherapy, and surgical management. High-level evidence supports solifenacin as the standard medical treatment for OAB, offering advantages such as not being affected by food intake, efficacy regardless of gender, and high bioavailability. However, it is known to cause discontinuation of treatment in many cases due to the occurrence of side effects. Posterior tibial nerve stimulation (PTNS) is a neuromodulation technique that has been internationally recognized and proven effective in the treatment of OAB, providing several advantages. It can be applied through two methods: percutaneous (PTNS) and transcutaneous (TTNS). PTNS is an invasive method that requires specialized equipment and a trained healthcare professional, which limits its routine use due to treatment costs.
In the literature, it is stated that in the treatment of OAB, alone or combined PTNS applications are superior to drug monotherapies, but there are limited studies on this subject. Therefore, the study aim was to compare the efficacy, side effects and quality of life of solifenacin and TTNS.
Read the detailed description
According to the inclusion and exclusion criteria, 34 female patients with OAB were enrolled in the study. The patients were randomly divided into two groups, with 17 individuals in each group. Patients with odd case numbers were assigned to the Oral Solifenacin group, while those with even case numbers were assigned to the TTNS group.
Prior to treatment, the sociodemographic characteristics, birth history, and past treatment information of all participants were recorded. Basic urogynecological evaluation, pelvic floor ultrasound, and urine culture were performed. To assess symptoms and quality of life, the Overactive Bladder Assessment Form (OAB-V8), Incontinence Quality of Life Scale (I-QQL), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a three-day bladder diary were used. After 6 weeks of treatment, all evaluations were repeated. The treatment regimen consisted of once-daily oral solifenacin for the medication group and 2 sessions per week, 30 minutes per session, for 12 sessions using the Urostim-2 device for the TTNS group. The stimulation intensity was increased until a motor or sensory response was obtained, and the threshold value was determined. The entire TTNS procedure was performed under the supervision of an expert physician at the Urogynecology Outpatient Clinic of Ege University Hospital. Statistical analysis was conducted using SPSS 20.0.
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome
- Being tested
- Oral Solifenacin 5mg, Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
- Keywords
- Overactive Bladder, Transcutaneous Electric Nerve Stimulation, Neuromodulation, Urge Urinary Incontinence, Quality of Life
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Solifenacin 5mgDrug
Also called Kinzy 5mg
Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks
Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)Device
Also called Urostim 2
Application of TTNS twice a week for 6 weeks, with each session for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Device Group | Active comparator | Transcutaneous device group with Urostim 2 Receives: Device: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS) |
| Drug Group | Active comparator | Drug Group with Kinzy 5 mg Receives: Drug: Oral Solifenacin 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Total Daily Incontinence Episodes
It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.
Measured: 6 weeks
Evaluation of Quality of Life
The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores. It is meaningful for patients. It is standardized. It takes into account the patient's daily activities. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
Measured: 6 weeks
Secondary outcomes (3)
Symptom Assessment
Overactive Bladder Assessment Form (OAB-V8), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A higher score means a worse outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
Measured: 6 weeks
Symptom Assessment
Urogenital Distress Inventory (UDI-6), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
Measured: 6 weeks
Symptom Assessment
Incontinence Impact Questionnaire (IIQ-7), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start18 Apr 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Ozgur Yeniel, Ege University
- Investigators
- Ahmet Ozgur OY Yeniel, Principal investigator, Ege University School of Medicine, Department of Obstetrics and Gynecology,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024005
- Sponsor's protocol ID
- TTNS for OAB
- Status last verified
- Sep 2023
- First submitted
- 2 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial: Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Oral Solifenacin Treatments' Effects in Women Between 18-80 Years Old Who Have Overactive Bladder
- ClinicalTrials.gov ID
- NCT06024005
- Acronym / sponsor ID
- TTNS for OAB
- Conditions
- Overactive Bladder, Overactive Bladder Syndrome
- Keywords
- Overactive Bladder, Transcutaneous Electric Nerve Stimulation, Neuromodulation, Urge Urinary Incontinence, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overactive bladder (OAB) syndrome is a symptom complex characterized by sudden urgency, frequent urination, nocturia, and urge incontinence without any identifiable organic cause, significantly impacting the quality of life. One of the most prominent symptoms is the urgency to urinate accompanied by a sudden sensation of bladder fullness.
There are various treatment options available for managing OAB, including conservative therapy, pharmacotherapy, and surgical management. High-level evidence supports solifenacin as the standard medical treatment for OAB, offering advantages such as not being affected by food intake, efficacy regardless of gender, and high bioavailability. However, it is known to cause discontinuation of treatment in many cases due to the occurrence of side effects. Posterior tibial nerve stimulation (PTNS) is a neuromodulation technique that has been internationally recognized and proven effective in the treatment of OAB, providing several advantages. It can be applied through two methods: percutaneous (PTNS) and transcutaneous (TTNS). PTNS is an invasive method that requires specialized equipment and a trained healthcare professional, which limits its routine use due to treatment costs.
In the literature, it is stated that in the treatment of OAB, alone or combined PTNS applications are superior to drug monotherapies, but there are limited studies on this subject. Therefore, the study aim was to compare the efficacy, side effects and quality of life of solifenacin and TTNS.
Detailed description
According to the inclusion and exclusion criteria, 34 female patients with OAB were enrolled in the study. The patients were randomly divided into two groups, with 17 individuals in each group. Patients with odd case numbers were assigned to the Oral Solifenacin group, while those with even case numbers were assigned to the TTNS group.
Prior to treatment, the sociodemographic characteristics, birth history, and past treatment information of all participants were recorded. Basic urogynecological evaluation, pelvic floor ultrasound, and urine culture were performed. To assess symptoms and quality of life, the Overactive Bladder Assessment Form (OAB-V8), Incontinence Quality of Life Scale (I-QQL), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a three-day bladder diary were used. After 6 weeks of treatment, all evaluations were repeated. The treatment regimen consisted of once-daily oral solifenacin for the medication group and 2 sessions per week, 30 minutes per session, for 12 sessions using the Urostim-2 device for the TTNS group. The stimulation intensity was increased until a motor or sensory response was obtained, and the threshold value was determined. The entire TTNS procedure was performed under the supervision of an expert physician at the Urogynecology Outpatient Clinic of Ege University Hospital. Statistical analysis was conducted using SPSS 20.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Group | Active comparator | Device: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)Transcutaneous device group with Urostim 2 |
| Drug Group | Active comparator | Drug: Oral Solifenacin 5mgDrug Group with Kinzy 5 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients with a diagnosis of OAB and unresponsive to first-line treatment,
- Absence of genito-urinary system malformations that may cause pollacullaire,
- Volunteering to participate in the research,
- To be literate in Turkish
Key exclusion criteria (11 listed)
- Having a urinary tract infection,
- Having pelvic organ prolapse greater than stage 2,
- To be diagnosed with stress type urinary incontinence,
- Having narrow-angle glaucoma, myasthenia gravis and severe gastro-intestinal diseases,
- Patients undergoing hemodialysis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Solifenacin 5mgAlso: Kinzy 5mgOral solifenacin (Kinzy 5mg) use once a day for 6 weeks | Drug | Drug Group |
| Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)Also: Urostim 2Application of TTNS twice a week for 6 weeks, with each session for 30 minutes | Device | Device Group |
Primary outcome
Number of Total Daily Incontinence Episodes
Time frame: 6 weeks
It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.
Evaluation of Quality of Life
Time frame: 6 weeks
The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores. It is meaningful for patients. It is standardized. It takes into account the patient's daily activities. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
3 secondary outcomes
Symptom Assessment
Time frame: 6 weeks
Symptom Assessment
Time frame: 6 weeks
Symptom Assessment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Ozgur OY Yeniel principal investigator
Ege University School of Medicine, Department of Obstetrics and Gynecology,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Solifenacin 5mg and Transcutaneous Posterior Tibial Nerve Stimulation (TTNS) in people with Overactive Bladder and Overactive Bladder Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Total Daily Incontinence Episodes (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.