Contact information
Type
Scientific
Primary contact
Prof Willem Bemelman
ORCID ID
Contact details
Meibergdreef 11
Amsterdam
1100 DD
Netherlands
w.a.bemelman@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC 03/281 # 04.17.0283
Study information
Scientific title
A prospective clinical trial of autonomic pelvic nerve damage in women with sexual dysfunction after restorative proctocolectomy with ileal pouch anal anastomosis (IPAA)
Acronym
Plexlab
Study hypothesis
Sexual dysfunction after ileal pouch anal anastomosis (IPAA) is common. The most systematic physical reaction to sexual stimulation is an increase in vaginal vasocongestion. Damage to the autonomic nerves disrupt this process. Genital response can be assessed by vaginal pulse amplitude using vaginal photoplethysmography. To date, little is known about the contribution of damage to the pelvic autonomic nerves. Aim of this prospective study was to assess whether IPAA is associated with autonomic pelvic nerve damage and changes in subjective indices of sexual function in women.
Ethics approval
Medische Ethische Commissie approved on the 25th February 2004 (ref: MEC 03/281 # 04.17.0283)
Study design
Single-centre prospective clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ulcerative colitis
Intervention
During sexual stimulation (visual and vibrotactile) changes in vaginal vasocongestion were measured by vaginal photoplethysmography. This is currently the most sensitive, specific and reliable instrument for measuring vaginal vasocongestion. Vaginal pulse amplitude (VPA) fluctuations reflect phasic changes in the blood content of the illuminated capillary bed of the vaginal wall at each heart beat, with greater amplitudes indicating increased vasoengorgement. Concurrently, quality of life (36-item short form health survey [SF-36]) and sexual functioning (Female Sexual Function Index [FSFI], Female Sexual Distress Scale [FSDS]) were assessed using validated questionnaires.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Measured pre- and post-operatively:
1. Difference in VPA
2. Feelings of sexual arousal and estimated lubrication
3. Difference in psychological and sexual functioning
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/04/2004
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female patients
2. Planned for a laparoscopic proctocolectomy with IPAA
3. Aged greater than 18 years
4. Informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
15
Participant exclusion criteria
1. Prior midline laparotomy
2. Operation on genitals
3. Diabetes mellitus
4. History of sexual abuse
5. Pre-existent sexual dysfunction
6. Use of medication with a possible effect on sexual response
7. Presence of a depressive disorder
Recruitment start date
01/04/2004
Recruitment end date
01/01/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 11
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Dutch Association for Gastroenterology (Nederlandse Vereniging voor Gastroenterologie) (Netherlands)
Sponsor details
Prof. dr. C.B.H.W. Lamers
Postbus 657
Haarlem
2003RR
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Gastrostart (Netherlands) (ref: CL/MvG/20.3/PROJECT 15-2003)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary