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NCT Number: NCT07710794

Transcutaneous Tibial Nerve Stimulation (TTNS) Patch in the Treatment of Patients With Lower Urinary Tract Symptoms (LUTS) After Benign Prostatic Hyperplasia (BPH) Surgery

The incidence of lower urinary tract symptoms (LUTS) with persistent overactive bladder (OAB) symptoms after benign prostatic hyperplasia (BPH) surgery ranges from approximately 5% to 35%, meaning that roughly one-third of patients remain troubled by symptoms such as urinary frequency, urgency, and increased nocturia following surgery.Current treatment options are limited. Although behavioral therapy (BT) is recommended as first-line treatment, patient compliance is often poor. Pharmacotherapy is associated with insufficient efficacy and adverse effects such as dry mouth, constipation, and cognitive impairment, which lead to low long-term medication adherence.

Transcutaneous tibial nerve stimulation (TTNS) has been proven effective in improving OAB symptoms and is recommended by multiple guidelines as one of the optional treatment modalities. However, research on its application in patients after BPH surgery remains lacking.The novel transcutaneous tibial nerve stimulation patch device offers the advantages of being non-invasive, portable, and suitable for home-based treatment. Whether combining this device with behavioral therapy can provide additional benefits for patients with refractory lower urinary tract symptoms after surgery needs to be verified through clinical research. Therefore, we plan to conduct this randomized controlled study to evaluate the efficacy and safety of the transcutaneous tibial nerve stimulation patch combined with behavioral therapy.

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Key information

Conditions

Lower Urinary Tract Symptoms (LUTS) BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shangdong, China

About this study

Eligible participants will be screened strictly according to the inclusion and exclusion criteria and enrolled until the required sample size is reached.

At enrollment, baseline data will be collected for all participants, including: (1) basic patient information, such as age and sex; (2) a standardized 72-hour voiding diary; (3) a current medication list; (4) the Overactive Bladder Symptom Score (OABSS); (5) the Patient Perception of Bladder Condition Scale (PPBC-S); (6) the Quality of Life scale (QOL); (7) the Self-Rating Anxiety Scale (SAS); (8) the International Prostate Symptom Score (IPSS).

Eligible participants will be randomly assigned to Group A or Group B in a 1:1 ratio. Participants in Group A will receive daily behavioral therapy, while participants in Group B will receive daily behavioral therapy plus transcutaneous tibial nerve stimulation (TTNS) using the patch, three times per week, 30 minutes per session, for a total of 12 weeks.

Follow-up visits will be conducted at Weeks 1, 4, 8, and 12 after enrollment. At each follow-up visit, the following data will be collected: (1) the standardized 72-hour voiding diary; (2) the current medication list; (3) OABSS; (4) PPBC-S; (5) QOL; (6) SAS; (7) IPSS; and (8) adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Male, aged 50 to 80 years. 2. Diagnosis of benign prostatic hyperplasia (BPH) confirmed by IPSS, imaging, PSA, pathology, or other relevant assessments.
  • Previous treatment with transurethral laser enucleation of the prostate for BPH.
  • Persistent overactive bladder symptoms one month after surgery, defined as an average of ≥8 voids per 24 hours documented on a 72-hour voiding diary.
  • Not currently using, or having discontinued at least 14 days prior to enrollment, all related medications (e.g., β3-adrenoceptor agonists, non-selective β-adrenoceptor agonists, or anticholinergics).
  • Medically stable and not requiring hospitalization. 7. Voluntary participation in this clinical study, with written informed consent signed by the participant before study initiation.

Exclusion criteria

  • 1. History of urinary tract infection, urinary tract malformation, obstruction, anatomical abnormality, or neurological disorder.
  • Known allergy to electrode gel or skin breakdown that precludes the use of surface electrodes.
  • Presence of psychiatric or cognitive impairment that renders the patient unable to cooperate with the study procedures.
  • Any serious comorbidity or condition that may hinder the patient's participation or increase the risk associated with surgical procedures.
  • Participation in another clinical trial within 3 months prior to screening that could potentially affect the results of this study.
  • Other conditions deemed unsuitable for participation by the investigator.

Treatment and study plan

Transcutaneous Tibial Nerve Stimulation (TTNS)

Device

Participants in Group A will receive daily behavioral therapy, while participants in Group B will receive daily behavioral therapy plus transcutaneous tibial nerve stimulation (TTNS) using the patch, three times per week, 30 minutes per session, for a total of 12 weeks.

Behavioral Treatment

Behavioral

Participants in Group A will receive daily behavioral therapy, while participants in Group B will receive daily behavioral therapy plus transcutaneous tibial nerve stimulation (TTNS) using the patch, three times per week, 30 minutes per session, for a total of 12 weeks.

Primary outcomes

  1. The frequency of daily urination over a period of three days

    Time frame: From enrollment to the end of treatment at 12 weeks

    Standardized 72-hour voiding diary, record the frequency of daily urination over a period of three days

Secondary outcomes

  1. The urgency severity、nocturia frequency and number of incontinence episodes over a period of three days

    Time frame: From enrollment to the end of treatment at 12 weeks

    Standardized 72-hour voiding diary, record the urgency severity、nocturia frequency and number of incontinence episodes over a period of three days

  2. Overactive Bladder Symptom Score (OABSS)

    Time frame: From enrollment to the end of treatment at 12 weeks

    The OABSS score is mainly used for initial severity grading, with total scores ranging from 0 to 15: 0-5 as mild, 6-11 as moderate, and 12-15 as severe.

  3. Patient Perception of Bladder Condition Scale (PPBC-S)

    Time frame: From enrollment to the end of treatment at 12 weeks

    The PPBC-S is a single-item, self-reported scale used to assess the patient's global perception of their bladder condition. The score ranges from 1 to 6, with higher scores indicating greater bother caused by the bladder condition. A score of 1 or 2 is generally regarded as mild, 3 or 4 as moderate, and 5 or 6 as severe.

  4. Quality of Life (QOL) Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

    The QOL scale used is the International Prostate Symptom Score quality of life question (IPSS-QoL). It is a single-item, self-reported assessment that asks: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" The score ranges from 0 (delighted) to 6 (terrible), with higher scores indicating a poorer quality of life due to urinary symptoms. A score of 0-1 is generally considered good, 2-3 as mixed, and 4-6 as poor.

  5. International Prostate Symptom Score (IPSS)

    Time frame: From enrollment to the end of treatment at 12 weeks

    The IPSS is a validated, self-administered questionnaire used to assess the severity of lower urinary tract symptoms. It consists of seven questions covering incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is scored from 0 to 5, yielding a total score ranging from 0 to 35. Severity is graded as mild (0-7), moderate (8-19), and severe (20-35).

  6. Self-Rating Anxiety Scale (SAS)

    Time frame: From enrollment to the end of treatment at 12 weeks

    The SAS is a self-administered questionnaire designed to assess the level of anxiety in patients. It consists of 20 items, each scored on a 4-point scale (1-4) based on the frequency of symptoms over the past week. The raw total score is multiplied by 1.25 to obtain a standardized score ranging from 25 to 100. Higher scores indicate greater anxiety severity. A standardized score of 50 or above suggests clinically significant anxiety, with 50-59 classified as mild, 60-69 as moderate, and ≥70 as severe.

  7. Safety endpoints and the occurrence of adverse events

    Time frame: From enrollment to the end of treatment at 12 weeks

    including pain and infection at the stimulation site, tibial nerve injury (e.g., motor dysfunction, neuralgia), and urological complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Li

CONTACT

[email protected]

+8618560089113

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Transcutaneous Tibial Nerve Stimulation (TTNS) Patch Combined With Behavioral Therapy (BT) Versus Behavioral Therapy in the Treatment of Patients With Lower Urinary Tract Symptoms (LUTS) After Benign Prostatic Hyperplasia (BPH) Surgery: a Prospective, Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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