Sacral ColpopexySEXQNCT01320631
Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
An observational study of Sacral Colpopexy and Pelvic Organ Prolapse, run by Atlantic Health System at 1 site in United States.
Trial summary
The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sacral Colpopexy, Pelvic Organ Prolapse
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male sexual partners of women who are sexually active and are scheduled to undergo a mesh augmented repair for pelvic organ prolapse referred to the Division of Urogynecology and Reconstructive Pelvic Surgery
Who may be able to join
- Sexually active couple at the time of pre-operative visit
- Female partner scheduled to undergo a mesh augmented repair
Who cannot join
- Not sexually active
- Use of other graft material than polypropylene mesh
- Contraindications to surgery based on existing medical conditions
- Pregnancy
- Desire for pregnancy in the future
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantic Health System
Morristown, New Jersey, 07960
About this study
The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. The investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). Another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse.
- Conditions
- Sacral Colpopexy, Pelvic Organ Prolapse
- Keywords
- uterine prolapse, vaginal prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacral ColpopexyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320631
- Sponsor's protocol ID
- R09-08-008
- Acronym
- SEXQ
- Status last verified
- Jun 2017
- First submitted
- 21 Mar 2011
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Culligan PJ, Haughey S, Lewis C, Priestley J, Salamon C. Sexual Satisfaction Changes Reported by Men After Their Partners' Robotic-Assisted Laparoscopic Sacrocolpopexies. Female Pelvic Med Reconstr Surg. 2019 Sep/Oct;25(5):365-368. doi: 10.1097/SPV.0000000000000574.
PubMed 29494351
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Sexual Experience and Its Impact on Quality of Life Before and After Their Sexual Partners Undergo Polypropylene Mesh Augmented Pelvic Floor Reconstruction
- ClinicalTrials.gov ID
- NCT01320631
- Acronym / sponsor ID
- SEXQ / R09-08-008
- Conditions
- Sacral Colpopexy, Pelvic Organ Prolapse
- Keywords
- uterine prolapse, vaginal prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. There are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. The investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. The sexual experience questionnaire (SEX-Q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). Another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male sexual partners of women who are sexually active and are scheduled to undergo a mesh augmented repair for pelvic organ prolapse referred to the Division of Urogynecology and Reconstructive Pelvic Surgery
Key inclusion criteria (2 listed)
- Sexually active couple at the time of pre-operative visit
- Female partner scheduled to undergo a mesh augmented repair
Key exclusion criteria (5 listed)
- Not sexually active
- Use of other graft material than polypropylene mesh
- Contraindications to surgery based on existing medical conditions
- Pregnancy
- Desire for pregnancy in the future
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Derived from this study: PubMed 29494351Culligan PJ, Haughey S, Lewis C, Priestley J, Salamon C. Sexual Satisfaction Changes Reported by Men After Their Partners' Robotic-Assisted Laparoscopic Sacrocolpopexies. Female Pelvic Med Reconstr Surg. 2019 Sep/Oct;25(5):365-368. doi: 10.1097/SPV.0000000000000574.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacral Colpopexy and Pelvic Organ Prolapse, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01320631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.