Prolotherapy treatment for bladder dysfunction

The Treatment Efficacy of Prolotherapy in Bladder Voiding Dysfunction

This study is testing if prolotherapy, which uses glucose injections, can help people with bladder problems feel better when current medications aren't working well.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Taichung Armed Forces General Hospital (other gov)
• Locations: 1 site (Taichung, Other (Non US))
• Trial ID: NCT05485142 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of prolotherapy, a treatment involving glucose injections, for patients suffering from overactive and underactive bladder conditions. It aims to address the limitations of current medications, which often have side effects leading to patient dropout. The trial will involve 80 participants who will receive weekly injections near the posterior tibial nerve for four weeks, followed by monthly follow-ups for three months. Various assessments, including symptom scores and a voiding diary, will be utilized to evaluate treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 20 years old diagnosed with overactive or underactive bladder who can complete a voiding diary and questionnaires.

Not a fit: Patients with severe urinary incontinence, pelvic organ prolapse, or other significant urinary tract issues may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with bladder voiding dysfunction, improving their quality of life.

How similar studies have performed: While similar approaches using neuromodulation have shown promise, the use of prolotherapy for this specific condition is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Adults over 20 years-old.
2. The patient who meets the diagnostic criteria of overactive bladder or underactive bladder.
3. The patient who capable to complete 3-days voiding diary and the questionnaire.

Exclusion Criteria:

1. Severe stress urinary incontinence or severe pelvic organ prolapse.
2. Acute urinary tract infection.
3. Active hematuria, urolithiasis, or neoplasm of urinary tract.
4. Acute skin lesion over the ankle injection site or the patient who could not tolerate ankle injection.
5. Pregnant women.

Where this trial is running

Taichung, Other (Non US)

• Taichung Armed Forces General Hospital — Taichung, Other (Non US), Taiwan (RECRUITING)

Study contacts

• Principal investigator: Jing-dung Shen — Taichung Armed Forces General Hospital
• Study coordinator: Jing-dung Shen, MD

Conditions: Overactive Bladder, Underactive Bladder, neural prolotherapy, detrusor underactivity, overactive bladder