Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse

NCT01092624 | Terminated Phase 4

• 2 other identifiers: TULI003042VESI-9I04
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pelvic Organ Prolapse

Keywords

voiding dysfunction; defecatory dysfunction; vaginal bulge symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  14-Weeks

Study Arms (2)

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

Interventions

Solifenacin DRUG

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.

Also known as: Vesicare

Pessary and solifenacin

Placebo DRUG

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.

Pessary and placebo

Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex DEVICE

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.

Pessary and placebo; Pessary and solifenacin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Hartford Hospital: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Solifenacin Succinate; Palliative Care

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paul Tulikangas, MD

  Hartford Hospital, Women's Specialty Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 25, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 4, 2011

Record last verified: 2011-11

Locations

US (1)