Is sexual dysfunction in women after restorative proctocolectomy with ileal pouch anal anastomosis (IPAA) caused by autonomic pelvic nerve damage?

ISRCTN	ISRCTN92260350
DOI	https://doi.org/10.1186/ISRCTN92260350
Secondary identifying numbers	MEC 03/281 # 04.17.0283

Submission date: 20/07/2009
Registration date: 18/08/2009
Last edited: 18/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Willem Bemelman
Scientific

Meibergdreef 11
Amsterdam
1100 DD
Netherlands

Email	w.a.bemelman@amc.nl

Study information

Study design	Single-centre prospective clinical trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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)
Study acronym	Plexlab
Study objectives	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(s)	Medische Ethische Commissie approved on the 25th February 2004 (ref: MEC 03/281 # 04.17.0283)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2004
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	15
Key inclusion criteria	1. Female patients 2. Planned for a laparoscopic proctocolectomy with IPAA 3. Aged greater than 18 years 4. Informed consent
Key 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
Date of first enrolment	01/04/2004
Date of final enrolment	01/01/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Meibergdreef 11

Amsterdam
1100 DD
Netherlands

Sponsor information

Dutch Association for Gastroenterology (Nederlandse Vereniging voor Gastroenterologie) (Netherlands)
Research organisation

Prof. dr. C.B.H.W. Lamers
Postbus 657
Haarlem
2003RR
Netherlands

Website	http://www.nvge.nl/
"ROR"	https://ror.org/0203tey58

Funders

Funder type

Research organisation

Gastrostart (Netherlands) (ref: CL/MvG/20.3/PROJECT 15-2003)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan