An interventional study of Transcutaneous Tibial Nerve Stimulation (TTNS) and Behavioral Treatment in Lower Urinary Tract Symptoms (LUTS) and BPH (Benign Prostatic Hyperplasia), sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 1 site in China. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
Among 21 studies in Lower Urinary Tract Symptoms with a site in China — 10 open to participants now, 10 under way, 1 of them phase 3. Lower Urinary Tract Symptoms · China.
Among the 21 studies in Lower Urinary Tract Symptoms with a site in China, this one is the 14th largest by planned enrollment of the 16 interventional ones that give a count, is one of 5 that started in 2026, is one of 11 with no phase, and was the 19th registered.
417 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
Browse Lower Urinary Tract Symptoms studies →10 of the 21 studies in Lower Urinary Tract Symptoms with a site in China are open now. Recruiting first, the newest first:
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 50+ · Men only
Chinese PLA General Hospital · Sites in China
Ages 40+ · Men only · Healthy volunteers
Société Internationale d'Urologie · Sites in China, United States, Canada and 18 more countries
Ages 18+ · Men only
Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Sites in China
Ages 40–80 · Men only
Zhongda Hospital · Sites in China
Ages 50–85 · Men only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 59 Lower Urinary Tract Symptoms studies recruiting now, 39 (66%) set no upper age limit and 11 (19%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.
This study: 50 Years to 80 Years · male · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 5 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is below the median of 100 across 272 interventional studies indexed under Lower Urinary Tract Symptoms.
Median enrollment 110 across the 16 interventional studies, 7,500 across the 5 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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3 of 21 have an industry lead sponsor. The 10 most frequent:
Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.
Qilu Hospital of Shandong University has 1 study filed under Lower Urinary Tract Symptoms — fewer than ten, so there is no comparison to draw.
4 of the studies in Lower Urinary Tract Symptoms with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07146386Phase 3Shanghai Huilun Pharmaceutical Co., Ltd.A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia | 2027-01 |
| NCT07710794Qilu Hospital of Shandong UniversityTranscutaneous Tibial Nerve Stimulation (TTNS) Patch in the Treatment of Patients With Lower Urinary Tract Symptoms (LUTS) After Benign Prostatic Hyperplasia (BPH) Surgery | 2027-01-31 |
| NCT06867315First Affiliated Hospital of Zhejiang UniversityTransperineal Irreversible Electroporation for Benign Prostatic Hyperplasia | 2027-05-29 |
| NCT07736807Zhongda HospitalEarly Electroacupuncture for Post-TURP LUTS | 2027-07-01 |
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Among the 21 studies in Lower Urinary Tract Symptoms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
1. Male, aged 50 to 80 years. 2. Diagnosis of benign prostatic hyperplasia (BPH) confirmed by IPSS, imaging, PSA, pathology, or other relevant assessments.
3. Previous treatment with transurethral laser enucleation of the prostate for BPH.
4. 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.
5. 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).
6. Medically stable and not requiring hospitalization. 7. Voluntary participation in this clinical study, with written signed by the participant before study initiation.
Exclusion Criteria:
1. History of urinary tract infection, urinary tract malformation, obstruction, anatomical abnormality, or neurological disorder.
2. Known allergy to electrode gel or skin breakdown that precludes the use of surface electrodes.
3. Presence of psychiatric or cognitive impairment that renders the patient unable to cooperate with the study procedures.
4. Any serious comorbidity or condition that may hinder the patient's participation or increase the risk associated with surgical procedures.
5. Participation in another clinical trial within 3 months prior to screening that could potentially affect the results of this study.
6. Other conditions deemed unsuitable for participation by the investigator.
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.
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.
Behavioral: Behavioral Treatment
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.
Device: Transcutaneous Tibial Nerve Stimulation (TTNS) · Behavioral: Behavioral Treatment
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.
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.
The frequency of daily urination over a period of three days
Standardized 72-hour voiding diary, record the frequency of daily urination over a period of three days
Time frame: From enrollment to the end of treatment at 12 weeks
The urgency severity、nocturia frequency and number of incontinence episodes over a period of three days
Standardized 72-hour voiding diary, record 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
Overactive Bladder Symptom Score (OABSS)
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Patient Perception of Bladder Condition Scale (PPBC-S)
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Quality of Life (QOL) Scale
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.
Time frame: From enrollment to the end of treatment at 12 weeks
International Prostate Symptom Score (IPSS)
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).
Time frame: From enrollment to the end of treatment at 12 weeks
Self-Rating Anxiety Scale (SAS)
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Safety endpoints and the occurrence of adverse events
including pain and infection at the stimulation site, tibial nerve injury (e.g., motor dysfunction, neuralgia), and urological complications.
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: Undecided
Start is estimated for Jun 2026; primary completion for Jan 2027, 7 months later.
Of 98 non-industry interventional studies with no phase under Lower Urinary Tract Symptoms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 7 months is below that.
Counting every sponsor, half of 119 studies reached it within 27 months; a quarter within 11 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Lower Urinary Tract Symptoms →
Qilu Hospital of Shandong University →