Pelvic Organ ProlapsePhase 4PESSARYNCT01092624
Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse
A Phase 4 study testing Solifenacin and Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex in people with Pelvic Organ Prolapse, run by Hartford Hospital at 1 site in United States.
Trial summary
This study will evaluate the effect of pessary therapy, with and without Solifenacin (Vesicare), on symptoms of over active bladder and bladder function in women with overactive bladder symptoms and pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Solifenacin and Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2011
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age ≥ 18 years
- Have experienced symptoms of overactive bladder (e.g., urinary urgency, frequency, or urge incontinence) for at least 3 months. Specifically women must average 8 or more voids in 24 hours and have 3 or more episodes of urinary urgency or urge incontinence over the 72 hours when the diary is being completed.
- A practitioner trained in the pelvic organ prolapse quantification examination will evaluate each woman's pelvic organ support and vaginal dimensions. Women with a stage 1 or greater vaginal prolapse will be eligible for the study.
Who cannot join
- The presence of factors that would contraindicate use of antimuscarinic medications (e.g. urine retention, narrow angle glaucoma, uncontrolled constipation, dementia)
- An existing condition that would contraindicate use of a vaginal pessary (e.g., patient's vaginal length <6 cm)
- Patient is currently using a vaginal pessary.
- Patient is unable to tolerate an object in vagina
- Patient has a history of cervical, vaginal or endometrial cancer
- Patient is not able to speak English
Show all 10Show fewer
- Patient is currently using an anticholinergic medication, or has used one in the past 30 days
- Patients with mixed urine incontinence that is predominantly stress urine incontinence (determined by their baseline PFDI)
- Patients with a known allergy to solifenacin.
- Patients with severe hepatic impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled Parallel-Design Trial of the Effect of Solifenacin Treatment for Overactive Bladder in Women With Anterior Vaginal Wall Prolapse Managed With a Pessary (the "PESSARY" Study)
This study will evaluate the effect of pessary therapy, with and without Solifenacin (Vesicare), on symptoms of over active bladder and bladder function in women with overactive bladder symptoms and pelvic organ prolapse.
Study Hypotheses:
Null hypothesis, HO: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does not improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.
Alternate hypothesis, HA: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.
Read the detailed description
Pelvic organ prolapse (POP) affects approximately half of all women over age 501. The most common type of POP is anterior vaginal wall prolapse. Symptoms associated with POP include: voiding dysfunction, defecatory dysfunction and vaginal bulge symptoms. Treatments for pelvic organ prolapse include among other options, vaginal pessary or surgery. Several studies have documented improved vaginal bulge symptoms in women treated with a pessary2,3,4; however, data are sparse regarding the effect of pessaries on lower urinary tract symptoms, specifically with regard to over active bladder symptoms.
Overactive bladder, observed in approximately 40% of women 50 years of age or older, is very common in women with pelvic organ prolapse. Two retrospective studies have shown improvement in women with overactive bladder symptoms following treatment with a vaginal pessary. One study (using a non-validated questionnaire) found that, at two month follow-up, patients successfully fitted with a pessary experienced a reduction in slightly less than half of their urge incontinence symptoms.5 A second study (using the Sheffield pelvic organ prolapse symptom questionnaire), revealed that 4 months after insertion of a pessary, 38% of patients experienced reduced urinary urgency, and 29% experienced reduced urge urinary incontinence6. Despite these data, many women stop using a pessary secondary to complaints of increased urine incontinence. More information is needed on pessary therapy impact on bladder function.
Specific Aim(s):
This study will prospectively evaluate women with pelvic organ prolapse and overactive bladder symptoms treated with either
- a pessary and solifenacin, or
- a pessary and placebo. We will assess the effects of these therapies on overactive bladder symptoms over the course of the 14-week study.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Solifenacin, Placebo, Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex
- Keywords
- voiding dysfunction, defecatory dysfunction, vaginal bulge symptoms
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
Also called Vesicare
There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.
PlaceboDrug
There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.
Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latexDevice
There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Pessary and solifenacin | Experimental | Not described Receives: Drug: Solifenacin; Device: Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex |
| Pessary and placebo | Placebo comparator | Not described Receives: Drug: Placebo; Device: Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of These Therapies on Over-Active Bladder Symptoms
Using the PFDI and PFIQ and a standardized medication response questionnaire to assess each subject's response to either the placebo or the solinefacin at Week 6 and Week 14, we will evaluate the effect of these therapies on subjects' bladder symptoms over the course of the study.
Measured: 14-Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: sponsor closed study due to poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Paul Tulikangas, MD, Principal investigator, Hartford Hospital, Women's Specialty Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092624
- Sponsor's protocol ID
- TULI003042
- Other IDs
- VESI-9I04
- Acronym
- PESSARY
- Status last verified
- Nov 2011
- First submitted
- 4 Mar 2010
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Parallel-Design Trial of the Effect of Solifenacin Treatment for Overactive Bladder in Women With Anterior Vaginal Wall Prolapse Managed With a Pessary (the "PESSARY" Study)
- ClinicalTrials.gov ID
- NCT01092624
- Acronym / sponsor ID
- PESSARY / TULI003042
- Conditions
- Pelvic Organ Prolapse
- Keywords
- voiding dysfunction, defecatory dysfunction, vaginal bulge symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor closed study due to poor enrollment
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Mar 2010 (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.
This study will evaluate the effect of pessary therapy, with and without Solifenacin (Vesicare), on symptoms of over active bladder and bladder function in women with overactive bladder symptoms and pelvic organ prolapse.
Study Hypotheses:
Null hypothesis, HO: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does not improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.
Alternate hypothesis, HA: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.
Detailed description
Pelvic organ prolapse (POP) affects approximately half of all women over age 501. The most common type of POP is anterior vaginal wall prolapse. Symptoms associated with POP include: voiding dysfunction, defecatory dysfunction and vaginal bulge symptoms. Treatments for pelvic organ prolapse include among other options, vaginal pessary or surgery. Several studies have documented improved vaginal bulge symptoms in women treated with a pessary2,3,4; however, data are sparse regarding the effect of pessaries on lower urinary tract symptoms, specifically with regard to over active bladder symptoms.
Overactive bladder, observed in approximately 40% of women 50 years of age or older, is very common in women with pelvic organ prolapse. Two retrospective studies have shown improvement in women with overactive bladder symptoms following treatment with a vaginal pessary. One study (using a non-validated questionnaire) found that, at two month follow-up, patients successfully fitted with a pessary experienced a reduction in slightly less than half of their urge incontinence symptoms.5 A second study (using the Sheffield pelvic organ prolapse symptom questionnaire), revealed that 4 months after insertion of a pessary, 38% of patients experienced reduced urinary urgency, and 29% experienced reduced urge urinary incontinence6. Despite these data, many women stop using a pessary secondary to complaints of increased urine incontinence. More information is needed on pessary therapy impact on bladder function.
Specific Aim(s):
This study will prospectively evaluate women with pelvic organ prolapse and overactive bladder symptoms treated with either
- a pessary and solifenacin, or
- a pessary and placebo. We will assess the effects of these therapies on overactive bladder symptoms over the course of the 14-week study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pessary and solifenacin | Experimental | Drug: Solifenacin, Device: Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex |
| Pessary and placebo | Placebo comparator | Drug: Placebo, Device: Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Age ≥ 18 years
- Have experienced symptoms of overactive bladder (e.g., urinary urgency, frequency, or urge incontinence) for at least 3 months. Specifically women must average 8 or more voids in 24 hours and have 3 or more episodes of urinary urgency or urge incontinence over the 72 hours when the diary is being completed.
- A practitioner trained in the pelvic organ prolapse quantification examination will evaluate each woman's pelvic organ support and vaginal dimensions. Women with a stage 1 or greater vaginal prolapse will be eligible for the study.
Key exclusion criteria (10 listed)
- The presence of factors that would contraindicate use of antimuscarinic medications (e.g. urine retention, narrow angle glaucoma, uncontrolled constipation, dementia)
- An existing condition that would contraindicate use of a vaginal pessary (e.g., patient's vaginal length <6 cm)
- Patient is currently using a vaginal pessary.
- Patient is unable to tolerate an object in vagina
- Patient has a history of cervical, vaginal or endometrial cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolifenacinAlso: VesicareThere will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily. | Drug | Pessary and solifenacin |
| PlaceboThere will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily. | Drug | Pessary and placebo |
| Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latexThere will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily. | Device | Pessary and placebo, Pessary and solifenacin |
Primary outcome
The Effect of These Therapies on Over-Active Bladder Symptoms
Time frame: 14-Weeks
Using the PFDI and PFIQ and a standardized medication response questionnaire to assess each subject's response to either the placebo or the solinefacin at Week 6 and Week 14, we will evaluate the effect of these therapies on subjects' bladder symptoms over the course of the study.
Results and safety
The study was stopped early (reason given: sponsor closed study due to poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
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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.
Paul Tulikangas, MD principal investigator
Hartford Hospital, Women's Specialty Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin and Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex in people with Pelvic Organ Prolapse, run by Hartford Hospital 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 Nov 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: sponsor closed study due to poor enrollment). Results are not available in the source record.
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.
What does the primary outcome measure?
The Effect of These Therapies on Over-Active Bladder Symptoms (time frame: 14-Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2011.