Condition category
Digestive System
Date applied
20/07/2009
Date assigned
18/08/2009
Last edited
18/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nvge.nl/

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

Publication citations

Additional files

Editorial Notes