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.
The aim of the study is to discover if PTNS can be used to reduce the symptoms in those
patients with tenesmus due to their pelvic floor disorders. These pelvic floor disorders
include rectal cancer in situ, Anterior Resection Syndrome developed after rectal-cancer
treatment, or gynaecological problems. Gynaecological problems that can cause tenesmus
include radiotherapy for gynaecological cancer, ovarian cysts, pelvic organ prolapse and
hysterectomy.
Currently, there is a lack of treatment options available to manage patients with tenesmus
and it is hoped that PTNS will provide a simple, non-invasive treatment to this wide patient
group with distressing symptoms. Assessment of symptom improvement will be used by analysing
the change in scores on the COREFO, e-PAQ and HADS questionnaires, which will be completed
pre and post treatment. COREFO is a validated questionnaire which includes questions
specifically relating to tenesmus. e-PAQ is a validated questionnaire which looks at all
aspects of the pelvic floor (bowel, urinary, vaginal, sexual) along with quality of life.
HADS is a validated questionnaire classifying the patient's degree of anxiety and depression
as either "normal", "borderline abnormal" or "abnormal".
There have been two pilot studies looking into the effect of PTNS in improving symptoms in
Anterior Resection Syndrome patients. However, full papers have not been published of this
data. These two studies assessed symptom improvement using questionnaires, but they did not
use COREFO, e-PAQ or HADS, or include patients who currently have rectal cancer (i.e. not
Anterior Resection Syndrome patients) or gynaecological problems and have the same tenesmus
symptoms. Thus this makes this research an original proposal. e-PAQ is widely used in STH to
assess pelvic floor symptoms, and thus its use here enables comparison with other patient
groups who also have PTNS as a treatment option.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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