An interventional study of Intravaginal ES and BT in Urinary Bladder, Overactive, sponsored by Pamukkale University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Pamukkale University · Not applicable, Interventional, and Other
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of IVES vs perineal ES in women with idiopathic OAB.
The main questions aimed to be answered are:
Is Intravaginal Electrical Stimulation (IVES) or perineal ES more effective on clinical parameters related to incontinence and quality of life in women with idiopathic overactive bladder (OAB)? Participants (n:63) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 3 groups using a randomization table. The first group will receive IVES and bladder training (n:21), second group will receive perineal ES and bladder training (n:21) and third group will receive bladder training (n=21) . Measurements will be performed twice in total, before and at the end of treatment (8th week).
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 63 is close to the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Pamukkale University is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, IVES will be administered in addition to BT. IVES will be performed in the lithotomy position using a vaginal probe and a stimulation device (Enraf Nonius Myomed 632). IVES will be performed three days a week for 20 minutes per day for 8 weeks, totaling 24 sessions. Stimulation parameters will be a frequency of 10 Hz, a 5-10 second work-rest cycle, and a 100 ms pulse width. A symmetrical biphasic pulse wave can be delivered in the range of 1-100 mA (based on the patient's discomfort level feedback) . IVES sessions will be performed by a physical medicine and rehabilitation physician.
Other: Intravaginal ES
Perineal ES will be administered in the lithotomy position using a combined electrotherapy stimulation device with surface electrodes (Enraf Nonius Myomed 632). Perineal ES will be administered 20 minutes per day, 3 days per week, for 8 weeks, for a total of 24 sessions. Stimulation parameters will be 10 Hz frequency, 5-10 s work-rest cycle, and 100 µs pulse width. A symmetrical biphasic current wave can be delivered in the 1-100 mA range (depending on the patient's discomfort level feedback). In this application, five 2 cm diameter surface electrodes will be used: four electrodes symmetrically in the perianal region and one electrode (ground-neutral electrode) on the leg. Patients will not perform voluntary contractions during ES. Surface electrodes will be used individually for each patient. Perineal ES sessions will be performed by a physical medicine and rehabilitation physician
Other: Perineal ES
All women will be informed about BT, which consists of four stages lasting 30 minutes. A written brochure will then be provided as a program that can be implemented at home. In the first stage, women will be informed about the location of the BT, pelvic anatomy, and pathophysiology. Following this informational session, they will be demonstrated how to squeeze the BT at least once using digital palpation techniques to suppress urgency. In the second stage, which includes urgency suppression strategies, the aim is to delay urination, inhibit detrusor contraction, and prevent urgency by squeezing the BT several times in a row, taking deep breaths, focusing on another task for a while, and self-motivating themselves. In the third stage, a timed voiding program will be initiated. This will be carried out in two steps: timed voiding and increasing the time between voids by keeping a voiding diary. In the final stage, women will be encouraged to continue BT
Other: BT
IVES will be performed in the lithotomy position using a vaginal probe and a stimulation device . IVES will be performed three days a week for 20 minutes per day for 8 weeks, totaling 24 sessions. Stimulation parameters will be a frequency of 10 Hz, a 5-10 second work-rest cycle, and a 100 ms pulse width. A symmetrical biphasic pulse wave can be delivered in the range of 1-100 mA (based on the patient's discomfort level feedback).
A written brochure will then be provided as a program that can be implemented at home. In the first stage, women will be informed about the location of the BT, pelvic anatomy, and pathophysiology. Following this informational session, they will be demonstrated how to squeeze the BT at least once using digital palpation techniques to suppress urgency. In the second stage, which includes urgency suppression strategies, the aim is to delay urination, inhibit detrusor contraction, and prevent urgency by squeezing the BT several times in a row, taking deep breaths, focusing on another task for a while, and self-motivating themselves. In the third stage, a timed voiding program will be initiated. This will be carried out in two steps: timed voiding and increasing the time between voids by keeping a voiding diary. In the final stage, women will be encouraged to continue BT
Perineal ES will be administered in the lithotomy position using a combined electrotherapy stimulation device with surface electrodes. Perineal ES will be administered 20 minutes per day, 3 days per week, for 8 weeks, for a total of 24 sessions. Stimulation parameters will be 10 Hz frequency, 5-10 s work-rest cycle, and 100 µs pulse width. A symmetrical biphasic current wave can be delivered in the 1-100 mA range (depending on the patient's discomfort level feedback). In this application, five 2 cm diameter surface electrodes will be used: four electrodes symmetrically in the perianal region and one electrode (ground-neutral electrode) on the leg. Patients will not perform voluntary contractions during ES. Surface electrodes will be used individually for each patient. Perineal ES sessions will be performed by a physical medicine and rehabilitation physician.
Improvement in rate incontinence episodes
Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
Time frame: Change from baseline Improvement in incontinence episodes at the 8th week after the treatment
The 24-hour pad test
The 24-hour pad test was carried out to evaluate the severity of incontinence
Time frame: Change from baseline the severity of incontinence at the 8th week after the treatment
Symptom severity
Overactive Bladder Questionnaire (OAB-V8) will be used to evaluate symptom severity in women with OAB in the study. The OAB-V8 consists of 8 questions in which patients can be classified as symptom severity: none (0), very little (1), a little (2), quite a few (3), very (4), and too many (5). The total score ranges from 0-40.
Time frame: Change from baseline symptom severity at the 8th week after the treatment
Frequency of voiding, nocturia, number of pads
The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.
Time frame: Change from baseline Frequency of voiding, nocturia, number of pads at the 8th week after the treatment
The Quality of Life
The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence. The scale consists of 7 questions and is scored on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 21 points. High scores mean bad results.
Time frame: Change from baseline the Quality of Life at the 8th week after the treatment
Anxiety and Depression level
The Hospital Anxiety and Depression Scale (HAD), validated and reliability tested in Turkey in 1987, assesses levels of anxiety and depression. It comprises 14 questions, seven for anxiety and seven for depression, scored on a four-point Likert scale. Scores are summed for each subscale: questions 1, 3, 5, 7, 9, 11, and 13 for anxiety, and questions 2, 4, 6, 8, 10, 12, and 14 for depression. In Turkey, cutoff scores are 10/11 for anxiety and 7/8 for depression, indicating risk.
Time frame: Change from baseline anxiety and Depression level at the 8th week after the treatment
Assessment of sexual functions Assessment of sexual functions
In the evaluation of sexual function, the Female Sexual Function Index questionnaire is used, consisting of 19 questions assessing six main factors: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain/discomfort. The highest possible total raw score is 95, while the lowest is 4. After multiplying the coefficients, the highest score is 36, and the lowest is 2. Impact coefficients used for scoring are: 0.6 for sexual desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. An Female Sexual Function Index score below 26.55 is indicative of sexual dysfunction
Time frame: Change from baseline assessment of sexual functions at the 8th week after the treatment
Cure and improvement rates
Cure and improvement rates will be recorded in all groups at the end-of-treatment assessments. Values under 1.3 g in the 24-hour pad test will be considered as "cure", while a 50% or greater reduction in wet weight compared to baseline measurements at the end of treatment will be considered as "improvement
Time frame: Change from baseline cure and improvement rates at the 8th week after the treatment
Treatment Satisfaction Level
At the end of the treatment, participants will be asked to evaluate their satisfaction level with the administered treatment using a Likert scale ranging from 1 to 5 (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, 1=very dissatisfied).
Time frame: Change from baseline Treatment Satisfaction Level at the 8th week after the treatment
Pelvic Floor Muscle (PFM) Strength
PFM strength will be assessed using the Peritron 9300 device
Time frame: Change from baseline Pelvic Floor Muscle (PFM) Strength at the 8th week after the treatment
Side Effects
All patients will be questioned about side effects such as numbness, fatigue, pain in and around the pelvic floor muscle, and changes and discomfort associated with defecation, drowsiness, headache, fatigue, and asthenia.
Time frame: 8th week
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 12 months is below that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
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