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 |
| Protocol serial number | MEC 03/281 # 04.17.0283 |
| Sponsor | Dutch Association for Gastroenterology (Nederlandse Vereniging voor Gastroenterologie) (Netherlands) |
| Funder | Gastrostart (Netherlands) (ref: CL/MvG/20.3/PROJECT 15-2003) |
- 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
Scientific
Meibergdreef 11
Amsterdam
1100 DD
Netherlands
| w.a.bemelman@amc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre prospective clinical trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Measured pre- and post-operatively: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
