What this trial studies
Urge urinary incontinence (UUI) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder affecting healthcare systems worldwide. The efficacy of therapeutic exercise and neuromodulation in the treatment of UUI is evaluated, and these techniques are combined.
Conditions in scope
- Urge Urinary Incontinence
- Overactive Bladder (OAB)
Interventions
- Neuromodulation (Procedure) — A protocol of posterior tibial nerve electrostimulation will be implemented, inducing retrograde electrostimulation through the pelvic nerves, which are connected to the spinal cord via the sacral plexus at segments S2 and S3. It is recommended to conduct an average…
- Exercise (Procedure) — Participants will engage in a 60-minute exercise session, divided into two blocks: Block 1 will comprise 10 to 12 repetitions per set, aiming to achieve a perceived exertion level of 7 to 10 on the rating of perceived exertion (RPE).…
- Exercise control group (Procedure) — Exercise The control group engages in specific pelvic floor exercises, which are less complex in terms of neuromuscular processing, such as Kegel's exercise. The protocol for these exercises is standardized and conducted individually, comprising 8 to 12 sessions of 20-40…
- Sham Neuromodulation (Procedure) — A needle with a retractable handle will be used, commonly employed in experimental research with Streitberger and Kleinhenz placebo needles. This creates the appearance of insertion without penetrating the skin and allows the needles to remain in place for the…
Who can join
Women only · Ages 45 Years and up
Inclusion criteria
- Present with a diagnosis of urinary incontinence or overactive bladder
- Women of menopausal age (\>45 years)
- ≥3 months of duration
- Fulfill the established criteria for patient selection for neuromodulation treatment (urge urinary incontinence)
- Speak native Spanish or English
Exclusion criteria
- Prior or scheduled surgical procedures in the lumbar or abdominal region
- Presence of fractures or severe pathological conditions
- Current pregnancy or potential for pregnancy during the study period
- Neurological or psychiatric disorders
- Presence of stress urinary incontinence
- Female subjects with autoimmune diseases or malignancies
- Belonephobia
- Subjects who have undergone previous neuromodulation
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Valencia | Valencia | Catholic Univerity of Valencia | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2025-03-04
- Primary completion: 2026-11-10
- Last update posted: 2025-04-13
- First posted: 2025-01-20
Sponsor & contact
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- The Overactive Bladder Questionnaire-Short Form (At baseline, Post1month, Post3months, Post6months)
The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a concise, self-administered patient-reported outcomes instrument comprising two scales that assess symptom bother and health-related quality of life (HR-QOL) in patients with OAB. This self-administered, disease-specific questionnaire evaluates symptomatic discomfort (6 items) and health-related quality of life (HRQoL, 13 items) using a 6-point Likert scale. Scores are transformed to a 0-100 scale,…
Related ClearedRx care
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Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06783374 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.