CystometryNCT06553469
Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury：A Prospective, Single-arm Study
An observational study of Cystometry and Sacral Neuromodulation, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury, as well as its preventive effect on complications of neurogenic lower urinary tract dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystometry, Sacral Neuromodulation, Ultrasound
- What is being tested?
- sacral neuromodulation
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The subjects were patients from Qilu Hospital, Shandong University.Recruitment process for research subjects:(1) Preliminary screening of patients based on admission and exclusion criteria;(2) Promote clinical trials to potential participants;(3) The assistant shall compile and organize the basic information and intention to participate in the trial of personnel who meet the recruitment requirements, inform them of the procedures for participating in the trial, and arrange for the recruitment of candidates to participate in the trial screening;(4) Researchers will further screen the recruited subjects according to the requirements of the experimental plan, and those who meet the requirements will be assigned to the group and included in the normal experimental procedure; For those that do not meet the requirements, notify the assistant to handle subsequent matters, such as explaining the work, distributing transportation subsidies, etc
Who may be able to join
- Age over 18 years old, gender not limited
- Diagnosed with urinary and defecation dysfunction caused by spinal cord injury
- Urodynamic examination suggests bladder dysfunction
- ASIA spinal cord injury classification: B, C, or D
- Safe bladder capacity>100ml
- Patients who can undergo sacral nerve regulation surgery after evaluation
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- If you plan not to combine medication during the study period, you need to stop taking the medication for at least 7 days before the screening period. If you plan to continue drug treatment during the study period, you need to maintain the same dosage or stop taking the medication after evaluation by a doctor.
- Voluntarily participate in this clinical study, and the subjects sign a written informed consent form before the start of the study.
- After testing treatment, if any of the following conditions are met, permanent implantation of a sacral nerve stimulator is feasible① The average daily frequency of urination during the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline;② The average urinary urgency score for the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline; ③ The number of urinary incontinence episodes in the last 3 days of experiential therapy decreased by ≥ 50% compared to baseline;④ The average urine output per session during the last 3 days of experiential therapy increased by ≥ 50% compared to baseline;⑤ The patient requires permanent implantation due to improvement in intestinal and sexual function, and after evaluation by the researcher, can undergo phase II treatment
Who cannot join
- Other causes of lower urinary tract dysfunction cannot be ruled out, or other diseases that may lead to lower urinary tract dysfunction cannot be ruled out
- Pregnant women, lactating women, women of childbearing age who plan to conceive or have no safe contraceptive measures during the study period
- Patients with mental and cognitive impairments, as well as those who are unable to cooperate with the experimental process
- Patients with untreated infections, coagulation disorders, malignant tumors, and other serious illnesses
- Individuals who have undergone other relevant surgical treatments within 3 months prior to enrollment (including but not limited to bladder wall injection of botulinum toxin type A), or have participated in other clinical trials
- Other situations that researchers consider inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
About this study
Official title: Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury
The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury, as well as its preventive effect on complications of neurogenic lower urinary tract dysfunction. We will use urodynamic examination results such as maximum bladder capacity and detrusor leak point pressure, combined with renal function and urinary ultrasound results, as our evaluation indicators. Follow up evaluations will be conducted at 6 and 12 months after permanent implantation, and periodic comparisons will be made with baseline data to gain a more comprehensive understanding of the effectiveness and safety of sacral nerve regulation surgery.
Read the detailed description
Spinal cord injury is a serious type of central nervous system injury that not only causes movement disorders, but also damages the bladder, intestines, and autonomic nervous circuits related to sexual function, leading to urinary and defecation disorders. Sacral nerve modulation is a technology that applies low-frequency electric pulse to specific sacral nerve continuously to affect and regulate the function of target organs, so as to treat urgent urinary incontinence, overactivity of bladder, urinary retention, fecal incontinence and other diseases. However, there is currently no consensus on whether this technology can treat urinary and defecation dysfunction caused by spinal cord injury, and its specific mechanism still needs to be studied. Existing research shows that this technique can reduce the excitability of sphincter by inhibiting the protective reflex to treat urinary retention; Treating detrusor overactivity by inhibiting detrusor muscle activity without affecting urethral resistance and detrusor muscle contraction during urination. This study hypothesizes that sacral nerve modulation intervention after spinal cord injury can reduce bladder spasms, maintain bladder compliance, bladder capacity, and low bladder filling pressure, delay the progression of bladder fibrosis and hydronephrosis after spinal cord injury, and improve symptoms such as constipation. Based on the above evidence and hypotheses, we designed a single arm clinical trial to evaluate the effectiveness and safety of sacral nerve modulation surgery in treating urinary and defecation dysfunction after incomplete spinal cord injury, especially in preventing complications such as bladder fibrosis and hydronephrosis. We also evaluated the impact of sacral nerve modulation surgery on the quality of life of patients after spinal cord injury, as well as the improvement effect of sacral nerve modulation surgery on urinary and reproductive system related symptoms and intestinal symptoms.
- Conditions
- Cystometry, Sacral Neuromodulation, Ultrasound
- Being tested
- sacral neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral neuromodulationDevice
After screening according to the inclusion and exclusion criteria, the subjects were enrolled in the study. The sacral nerve regulation treatment was divided into two phases. Phase I was the testing phase, during which the sacral nerve stimulation electrode component was implanted. After the electrode was implanted, it was tested for 2-4 weeks. According to the urine diary and scale scores, if the symptoms improved by ≥ 50%, or if the patient requested to continue with Phase II and was evaluated by the researcher as suitable for implantation, Phase II (permanent implantation phase) treatment was performed, during which the sacral nerve stimulation pulse generator component was implanted
| Study group | Role | What they receive |
|---|---|---|
| SNM group | After screening according to the inclusion and exclusion criteria, the subjects were enrolled in the study. The sacral nerve regulation treatment was divided into two phases. Phase I was the testing phase, during which sacral nerve stimulation electrode component implantation was performed. After electrode implantation, testing was conducted for 2-4 weeks. According to the urine diary and scale scores, if the symptoms improved by ≥ 50%, or if the patient requested to continue with phase II and was evaluated by the researcher as suitable for implantation, phase II (permanent implantation phase) treatment was performed, and sacral nerve stimulation pulse generator component implantation was performed.During the trial period, all patients in the intervention group received routine care for neurogenic lower urinary tract dysfunction, including regular clean interval catheterization (CIC), in addition to sacral nerve regulation therapy Receives: Device: sacral neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
urodynamics
To examine function of bladder
Measured: 3,6,12 month
renal function
To examine function of kidney
Measured: 3,6,12 month
Urinary ultrasound
morphological change of urinary system
Measured: 3,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CystometryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lipeng Chen, Dortor, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553469
- Sponsor's protocol ID
- YL01
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Jazayeri SB, Maroufi SF, Mohammadi E, Dabbagh Ohadi MA, Hagen EM, Chalangari M, Jazayeri SB, Safdarian M, Zadegan SA, Ghodsi Z, Rahimi-Movaghar V. Incidence of traumatic spinal cord injury worldwide: A systematic review, data integration, and update. World Neurosurg X. 2023 Feb 1;18:100171. doi: 10.1016/j.wnsx.2023.100171. eCollection 2023 Apr.
PubMed 36910686Quadri SA, Farooqui M, Ikram A, Zafar A, Khan MA, Suriya SS, Claus CF, Fiani B, Rahman M, Ramachandran A, Armstrong IIT, Taqi MA, Mortazavi MM. Recent update on basic mechanisms of spinal cord injury. Neurosurg Rev. 2020 Apr;43(2):425-441. doi: 10.1007/s10143-018-1008-3. Epub 2018 Jul 11.
PubMed 29998371Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, Rosenbluth JP, Presson AP, Myers JB; Neurogenic Bladder Research Group (NBRG.org). Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury. BMC Urol. 2018 Aug 29;18(1):72. doi: 10.1186/s12894-018-0383-y.
PubMed 30157824
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sacral Nerve Modulation on Urinary and Defecation Dysfunction After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06553469
- Acronym / sponsor ID
- YL01
- Conditions
- Cystometry, Sacral Neuromodulation, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the long-term efficacy of sacral nerve modulation surgery in the treatment of neurogenic lower urinary tract dysfunction caused by incomplete spinal cord injury, as well as its preventive effect on complications of neurogenic lower urinary tract dysfunction. We will use urodynamic examination results such as maximum bladder capacity and detrusor leak point pressure, combined with renal function and urinary ultrasound results, as our evaluation indicators. Follow up evaluations will be conducted at 6 and 12 months after permanent implantation, and periodic comparisons will be made with baseline data to gain a more comprehensive understanding of the effectiveness and safety of sacral nerve regulation surgery.
Detailed description
Spinal cord injury is a serious type of central nervous system injury that not only causes movement disorders, but also damages the bladder, intestines, and autonomic nervous circuits related to sexual function, leading to urinary and defecation disorders. Sacral nerve modulation is a technology that applies low-frequency electric pulse to specific sacral nerve continuously to affect and regulate the function of target organs, so as to treat urgent urinary incontinence, overactivity of bladder, urinary retention, fecal incontinence and other diseases. However, there is currently no consensus on whether this technology can treat urinary and defecation dysfunction caused by spinal cord injury, and its specific mechanism still needs to be studied. Existing research shows that this technique can reduce the excitability of sphincter by inhibiting the protective reflex to treat urinary retention; Treating detrusor overactivity by inhibiting detrusor muscle activity without affecting urethral resistance and detrusor muscle contraction during urination. This study hypothesizes that sacral nerve modulation intervention after spinal cord injury can reduce bladder spasms, maintain bladder compliance, bladder capacity, and low bladder filling pressure, delay the progression of bladder fibrosis and hydronephrosis after spinal cord injury, and improve symptoms such as constipation. Based on the above evidence and hypotheses, we designed a single arm clinical trial to evaluate the effectiveness and safety of sacral nerve modulation surgery in treating urinary and defecation dysfunction after incomplete spinal cord injury, especially in preventing complications such as bladder fibrosis and hydronephrosis. We also evaluated the impact of sacral nerve modulation surgery on the quality of life of patients after spinal cord injury, as well as the improvement effect of sacral nerve modulation surgery on urinary and reproductive system related symptoms and intestinal symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNM group | – | Device: sacral neuromodulationAfter screening according to the inclusion and exclusion criteria, the subjects were enrolled in the study. The sacral nerve regulation treatment was divided into two phases. Phase I was the testing phase, during which sacral nerve stimulation electrode component implantation was performed. After electrode implantation, testing was conducted for 2-4 weeks. According to the urine diary and scale scores, if the symptoms improved by ≥ 50%, or if the patient requested to continue with phase II and was evaluated by the researcher as suitable for implantation, phase II (permanent implantation phase) treatment was performed, and sacral nerve stimulation pulse generator component implantation was performed.During the trial period, all patients in the intervention group received routine care for neurogenic lower urinary tract dysfunction, including regular clean interval catheterization (CIC), in addition to sacral nerve regulation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The subjects were patients from Qilu Hospital, Shandong University.Recruitment process for research subjects:(1) Preliminary screening of patients based on admission and exclusion criteria;(2) Promote clinical trials to potential participants;(3) The assistant shall compile and organize the basic information and intention to participate in the trial of personnel who meet the recruitment requirements, inform them of the procedures for participating in the trial, and arrange for the recruitment of candidates to participate in the trial screening;(4) Researchers will further screen the recruited subjects according to the requirements of the experimental plan, and those who meet the requirements will be assigned to the group and included in the normal experimental procedure; For those that do not meet the requirements, notify the assistant to handle subsequent matters, such as explaining the work, distributing transportation subsidies, etc
Key inclusion criteria (9 listed)
- Age over 18 years old, gender not limited
- Diagnosed with urinary and defecation dysfunction caused by spinal cord injury
- Urodynamic examination suggests bladder dysfunction
- ASIA spinal cord injury classification: B, C, or D
- Safe bladder capacity>100ml
Key exclusion criteria (6 listed)
- Other causes of lower urinary tract dysfunction cannot be ruled out, or other diseases that may lead to lower urinary tract dysfunction cannot be ruled out
- Pregnant women, lactating women, women of childbearing age who plan to conceive or have no safe contraceptive measures during the study period
- Patients with mental and cognitive impairments, as well as those who are unable to cooperate with the experimental process
- Patients with untreated infections, coagulation disorders, malignant tumors, and other serious illnesses
- Individuals who have undergone other relevant surgical treatments within 3 months prior to enrollment (including but not limited to bladder wall injection of botulinum toxin type A), or have participated in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacral neuromodulationAfter screening according to the inclusion and exclusion criteria, the subjects were enrolled in the study. The sacral nerve regulation treatment was divided into two phases. Phase I was the testing phase, during which the sacral nerve stimulation electrode component was implanted. After the electrode was implanted, it was tested for 2-4 weeks. According to the urine diary and scale scores, if the symptoms improved by ≥ 50%, or if the patient requested to continue with Phase II and was evaluated by the researcher as suitable for implantation, Phase II (permanent implantation phase) treatment was performed, during which the sacral nerve stimulation pulse generator component was implanted | Device | SNM group |
Primary outcome
urodynamics
Time frame: 3,6,12 month
To examine function of bladder
renal function
Time frame: 3,6,12 month
To examine function of kidney
Urinary ultrasound
Time frame: 3,6,12 month
morphological change of urinary system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 36910686Jazayeri SB, Maroufi SF, Mohammadi E, Dabbagh Ohadi MA, Hagen EM, Chalangari M, Jazayeri SB, Safdarian M, Zadegan SA, Ghodsi Z, Rahimi-Movaghar V. Incidence of traumatic spinal cord injury worldwide: A systematic review, data integration, and update. World Neurosurg X. 2023 Feb 1;18:100171. doi: 10.1016/j.wnsx.2023.100171. eCollection 2023 Apr.
- Background: PubMed 29998371Quadri SA, Farooqui M, Ikram A, Zafar A, Khan MA, Suriya SS, Claus CF, Fiani B, Rahman M, Ramachandran A, Armstrong IIT, Taqi MA, Mortazavi MM. Recent update on basic mechanisms of spinal cord injury. Neurosurg Rev. 2020 Apr;43(2):425-441. doi: 10.1007/s10143-018-1008-3. Epub 2018 Jul 11.
- Background: PubMed 30157824Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, Rosenbluth JP, Presson AP, Myers JB; Neurogenic Bladder Research Group (NBRG.org). Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury. BMC Urol. 2018 Aug 29;18(1):72. doi: 10.1186/s12894-018-0383-y.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lipeng Chen, Dortor study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystometry and Sacral Neuromodulation, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Li, Dortor (18560089113, yanli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urodynamics (time frame: 3,6,12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553469, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.