An observational controlled study on vaginal blood flow, sexual functioning, bladder and bowel function after radiation therapy following nerve-sparing radical hysterectomy for early stage cervical cancer (FIGO IA2-IIA).

The primary treatment for women with early-stage (FIGO IA2 - IIA) cervical
cancer is radical hysterectomy with pelvic lymphadenectomy (RHL). In
approximately one third of women, surgery is followed by postoperative
radiation therapy. Radiation therapy is administered if the parametrium is
tumor positive or the surgical margins (especially the vaginal margin) are
positive. Additionally, tumor characteristics (tumor size > 40 mm, invasion
depth > 15 mm and lympho-vascular space invasion) can be taken into account to
advise women postoperative radiation therapy since these criteria seem to
result in worse prognosis. When two out of three characteristics are met in a
patient, postoperative radiation is advised, for it is known to improve the
prognosis1.
Although the results in terms of survival for low stage cervical carcinoma are
reasonably good, the morbidity is still a matter of concern. Besides
infertility due to the treatment, problems with miction, defecation and
sexuality may effect quality of life.

With the conventional RHL, the pelvic autonomic nerves (especially the
hypogastic plexus) are damaged. This leads to disrupted autonomic innervation
of the bladder, rectum, and the blood vessels in the vaginal wall.
Consequently, patients often experience various postoperative complaints
concerning sexual functioning, bowel and bladder function. Externalbeam
radiation therapy also causes sexual dysfunction and vaginal changes by chronic
fibrotic changes in pelvic tissue.Studies on rectal carcinoma have shown that
pre-operative radiation therapy is a significant risk factor for overall
decreased sexual functioning, both in men and women. After surgery, alone or in
combination with radiation therapy, several symptoms related to sexual
dysfunction appeared to be the primary sources of symptom-induced distress.

A preliminary study by Pieterse et al (CME protocolno. P05.095) on nerve
sparing RHL has shown outcomes of less disrupted vaginal blood flow in
response to sexual stimuli in patients after nerve sparing RHL compared to
conventional RHL4. Vaginal blood flow in nerve sparing RHL showed to be
comparable to women after simple hysterectomy and women without hysterectomy.
This study will reveal the relative impact of nerve-sparing surgery and
external beam radiation on sexual functioning, bladder- and bowel function.

In this controlled (studygroups from P05-095 will serve as controls)
observational study, the effects of radiation therapy after nerve-sparing
radical hysterectomy for early stage cervical cancer on sexual function,
bladder and bowel function is assessed with the use of VPA (Vaginal Pulse
Amplitude) measurement and validated questionnaires.

Hypothesis:

External beam radiation after nerve sparing radical hysterectomy will undo the
positive effect of nerve-sparing surgery on of the well known sexual-, bladder-
and bowel complaints as observed after treatment for early stage cervical
cancer.

An observational study with the use of questionnaires and vaginal pulse
amplitude (VPA) measuring by photoplethysmography. Women who have been treated
in the past with radical hysterectomy and post-operative radiation therapy will
be approached and asked to participate. Participating women are asked to fill
in three validated questionnaires: EORTC QLQ-C30 (general quality of life
questionnaire for cancer patients), EORTC QLQ-CX24 (cervix carcinoma-specific
quality of life questionnaire) and the Gynaecologic Leiden Questionnaire
(specific questionnaire for sexual and pelvic floor symptoms). Copyright
holding authorities have approved the use of the questionnaires.
Furthermore, VPA will be measured to evaluate genital arousal.

The outcome of both the questionnaires as well as the VPA measurement will be
compared for women after conventional radical hysterectomy without
post-operative radiation therapy, after normal hysterectomy and normal
controles (studygroups from P05-095).

For this study, the patient will visit the LUMC once. During the first part of
this visit, written informed consent will be obtained. Subjects will fill out
the questionnaires. Subsequently, the researcher will explain all procedures of
the vaginal plethysmography in detail. She also shows and explains the devices
used in the genital measurement.

The second part of the visit will consist of the experimental session with the
vaginal photoplethysmography and the neutral and erotic filmfragements. After
this experimental procedure, a brief exit-interview will take place.

It is possible that some parts of this study may be experienced as unpleasant,
such as watching erotic film excerpts or the insertion of the measuring device.
The odds of experiencing pain when inserting the measuring device is very low,
due to the size of the device (shape and size are similar to a tampon) en the
smoothness of the material. Further, vaginal lubricants may be used to insert
the measuring device. At any moment during the experiment the experiment can be
stopped if the women wants so.