PTNS as a Treatment for Tenesmus

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Pelvic Floor Disorders

Clinical Trial Details

NCT number	NCT02270190
Study type	Interventional
Source	Sheffield Teaching Hospitals NHS Foundation Trust
Contact
Status	Recruiting
Phase	N/A
Start date	August 2014
Completion date	April 2015

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