Pelvic Floor Disorders Clinical Trial
Official title:
Evaluating the Effectivenemss of Percutaneous Tibial Nerve Stimulation as a Treatment for Tenesmus in Patients With Pelvic Floor Disorders
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of General Surgery | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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