PTNS as a Treatment for Tenesmus
Evaluating the Effectivenemss of Percutaneous Tibial Nerve Stimulation as a Treatment for Tenesmus in Patients With Pelvic Floor Disorders
2 other identifiers
interventional
10
1 country
1
Brief Summary
The main research question is to see if Percutaneous Tibial Nerve Stimulation (PTNS) can improve the symptom of tenesmus in patients with pelvic floor disorders. This includes those who have rectal cancer in situ or who are post-rectal cancer treatment and have Anterior Resection Syndrome. The secondary research questions are to see if other pelvic floor symptoms and quality of life improves for this patient group and if levels of anxiety and depression improve for these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 16, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedOctober 21, 2014
October 1, 2014
8 months
October 16, 2014
October 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
improve the symptom of tenesmus in patients with pelvic floor disorders
The degree of success of the PTNS treatment will be measured by comparing the results from the COREFO, e-PAQ and HADS questionnaires before and after the 12 weeks of treatment. The treatment will be deemed successful if the post-treatment score is significantly lower than the pre-treatment score.
12 weeks
Study Arms (1)
tenesmus patients
OTHERPercutaneous Tibial Nerve Stimulation (PTNS) will be applied to all patients in the study
Interventions
Eligibility Criteria
You may qualify if:
- Patients that have tenesmus who are post-rectal cancer treatment and have Anterior Resection Syndrome.
- Patients that have tenesmus who have a rectal cancer.
- Patients that have tenesmus due to a gynaecological condition.
You may not qualify if:
- Anyone under the age of 18.
- Anyone with a pacemaker or implantable defibrillator.
- Anyone who is prone to excessive bleeding.
- Anyone who is pregnant or is planning on becoming pregnant throughout their time in the trial.
- Anyone with diabetic neuropathy, multiple sclerosis, Parkinson's disease or peripheral neuropathy.
- Inability to provide consent for the research study.
- Anatomical limitations that would prevent successful placement of needle electrode.
- Present evidence of external full thickness rectal prolapse.
- Stoma in situ.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General Surgery
Sheffield, South Yorkshire, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2014
First Posted
October 21, 2014
Study Start
August 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
October 21, 2014
Record last verified: 2014-10