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The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool incontinence.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacral nerve modulation | Device | electric stimulation of the sacral nerve using an implanted electrode and stimulator |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Considering the Treatment a Success After 5 Years | Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Considering the Treatment a Success After 1 Years | Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints | 1 year |
| Percentage of Patients Considering the Treatment a Success After 3 Years |
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Inclusion Criteria:
Exclusion Criteria:
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patients starting an SNM treatment for constipation or fecal incontinence between March 2006 and October 2015
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| Name | Affiliation | Role |
|---|---|---|
| Lukas Marti, MD | Cantonal Hospital of St. Gallen | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30646487 | Result | Widmann B, Galata C, Warschkow R, Beutner U, Ogredici O, Hetzer FH, Schmied BM, Post S, Marti L. Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study. J Neurogastroenterol Motil. 2019 Jan 31;25(1):159-170. doi: 10.5056/jnm17106. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FI Group | Patients suffering from fecal incontinence (only). |
| FG001 | Con Group | Patients suffering from fecal constipation (only). |
| FG002 | FI+Con Group | Patients suffering from fecal incontinence and constipation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Phase |
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| Study Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | FI Group | Patients suffering from fecal incontinence (only). |
| BG001 | Con Group | Patients suffering from fecal constipation (only). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Considering the Treatment a Success After 5 Years | Treatment is considered a success if a patients reports a subjective 50% reduction in disease related complaints | Rate of successfully treated patients based on time-to-event ("Kaplan-Meier") statistic | Posted | Number | 95% Confidence Interval | percentage of success | 5 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FI Group | Patients suffering from fecal incontinence (only). | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other: Broken or dislocated lead | Product Issues | Systematic Assessment | Stimulator lead broken or dislocated. Correct stimulation no longer possible |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other: Dislocated lead | Product Issues | Systematic Assessment | Stimulator lead dislocated. Correct stimulation no longer possible |
Observed death was unrelated to study treatment or study participation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lukas Marti | Department of Surgery, Cantonal Hospital St. Gallen | +41 71 494 11 11 | lukas.marti@kssg.ch |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
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Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints |
| 3 year |
| Number of Patients at Risk After 1 Year | patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/). | 1 year |
| Number of Patients at Risk After 3 Years | patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/). | 3 year |
| Number of Patients at Risk After 5 Years | patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/). | 5 year |
| Rate of Permanent Stimulator Implantations | Rate of patients who finished the test phase with an external stimulator successfully (subjective reporting and 50% reduction of Wexner score for incontinence) | 1 month |
| NOT COMPLETED |
|
|
| BG002 | FI+Con Group | Patients suffering from fecal incontinence and constipation. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients suffering from fecal constipation (only). |
| OG003 | FI+Con Group | Patients suffering from fecal incontinence and constipation. |
|
|
| Secondary | Percentage of Patients Considering the Treatment a Success After 1 Years | Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints | Posted | Number | 95% Confidence Interval | percentage of success | 1 year |
|
|
|
| Secondary | Percentage of Patients Considering the Treatment a Success After 3 Years | Treatment is considered a success if a patient reports a subjective 50% reduction in disease related complaints | Posted | Number | 95% Confidence Interval | percentage of success | 3 year |
|
|
|
| Secondary | Number of Patients at Risk After 1 Year | patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/). | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Number of Patients at Risk After 3 Years | patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/). | Posted | Number | participants | 3 year |
|
|
|
| Secondary | Number of Patients at Risk After 5 Years | patients at risk according time-to-event statistics, i.e. number of participants still under evaluation, i.e. all participants minus the ones who have died, dropped out, or move out at the time of evaluation (https://en.wikipedia.org/wiki/Kaplan%E2%80%93Meier\_estimator, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3059453/). | Posted | Number | participants | 5 year |
|
|
|
| Secondary | Rate of Permanent Stimulator Implantations | Rate of patients who finished the test phase with an external stimulator successfully (subjective reporting and 50% reduction of Wexner score for incontinence) | Posted | Count of Participants | Participants | 1 month |
|
|
|
| 59 |
| 28 |
| 59 |
| 11 |
| 59 |
| EG001 | Con Group | Patients suffering from fecal constipation (only). | 0 | 8 | 6 | 8 | 1 | 8 |
| EG002 | FI+Con Group | Patients suffering from fecal incontinence and constipation. | 0 | 12 | 4 | 12 | 0 | 12 |
|
| Device related infection | Infections and infestations | CTCAE | Systematic Assessment | A disorder characterized by an infectious process involving the use of a medical device |
|
| Pain | General disorders | CTCAE | Systematic Assessment |
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| Other: Pulse generator dislocation | Product Issues | Systematic Assessment |
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| Other: Device failure | Product Issues | Systematic Assessment | Loss of function of neural stimulator |
|
|
| Device related infection | Infections and infestations | CTCAE | Systematic Assessment | A disorder characterized by an infectious process involving the use of a medical device |
|
| Pain | General disorders | CTCAE | Systematic Assessment |
|
| Other | Product Issues | Systematic Assessment |
|
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| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |